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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001634-10 | EudraCT Number |
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This study seeks to evaluate the efficacy and safety of ABBV-8E12 in participants with early Alzheimer's disease (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo for ABBV-8E12 every 4 weeks for 96 weeks |
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| ABBV-8E12 300 mg | Experimental | ABBV-8E12 300 mg every 4 weeks for 96 weeks |
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| ABBV-8E12 1000 mg | Experimental | ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
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| ABBV-8E12 2000 mg | Experimental | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-8E12 | Drug | ABBV-8E12 solution for IV infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Over Time in CDR-SB Score | The CDR-SB is a numeric scale used to quantify the severity of symptoms of dementia. A qualified health professional assesses a participant's cognitive and functional performance in 6 areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The CDR scale gives a score from 0 to 3 for each of the 6 areas, with a lower value being desirable. The sum of these 6 areas, the CDR-SB score, can range from 0 to 18, with a lower value being desirable. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | A TEAE was defined as an adverse event (AE) that began on or after the first study drug dose date and no more than 20 weeks after the last dose of study drug. An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. Serious AEs (SAEs) were defined as an event that results in death, is life-threatening, results in hospitalization or prolongs hospitalization, is a congenital abnormality, results in persistent or significant disability/incapacity, or is an important medical event. Events were rated in severity as mild, moderate, or severe, and were categorized as having a reasonable possibility or no reasonable possibility of relationship to study drug. | From first dose of study drug up to last dose of study drug plus 20 weeks (up to Week 112) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses | Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99. | |
| Time to Cmax (Tmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses |
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Inclusion Criteria:
Subject who meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have:
Subject has a positive amyloid positron emission tomography (PET) scan.
Subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4.
The subject has an identified, reliable, study partner (e.g., family member).
If using medications to treat symptoms related to AD, doses must be stable for at least 12 weeks prior to randomization.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University of Arizona Medical Center Phoenix /ID# 151536 | Phoenix | Arizona | 85006 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41281734 | Derived | Wang D, Florian H, Lynch SY, Robieson W, Zhuang R, Kusiak C, Ross JL, Walsh JR, Graff O. Using AI-generated digital twins to boost clinical trial efficiency in Alzheimer's disease. Alzheimers Dement (N Y). 2025 Nov 22;11(4):e70181. doi: 10.1002/trc2.70181. eCollection 2025 Oct-Dec. |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing, please refer to the link below.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo for ABBV-8E12 every 4 weeks for 96 weeks |
| FG001 | ABBV-8E12 300 mg | ABBV-8E12 300 mg every 4 weeks for 96 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 2, 2020 | Jul 5, 2022 |
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| placebo for ABBV-8E12 | Drug | placebo solution for intravenous (IV) infusion |
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| Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99. |
| Serum Concentration at the End of a Dose Interval (Ctrough) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses | Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99. |
| Half-Life (T1/2) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses | Harmonic mean is presented in the data table. | Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99. |
| Area Under the Concentration-Time Curve From Dosing (Time 0) to Day 28 (AUC0-28) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses |
| Day 1 (Dose 1): pre-infusion, up to Day 29 (trough level before Dose 2). Day 85 (Dose 4): pre-infusion, up to Day 113 (trough level before Dose 5). See Outcome Measure description above for complete time point details. |
| Cmax/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses | Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99. |
| AUC0-28/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses |
| Day 1 (Dose 1): pre-infusion, up to Day 29 (trough level before Dose 2). Day 85 (Dose 4): pre-infusion, up to Day 113 (trough level before Dose 5). See Outcome Measure description above for complete time point details. |
| Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) Total Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in mild cognitive impairment (MCI) patients. The Total Score of the ADAS-Cog-14 ranges from 0 to 90, with a higher score representing greater impairment. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Comprehension of Spoken Language score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Constructional Praxis Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in ADAS-Cog-14 Commands Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Commands Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in ADAS-Cog-14 Delayed Word Recall Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Delayed Word Recall Score of the ADAS-Cog-14 ranges from 0 to 10, with a higher score representing greater impairment. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in ADAS-Cog-14 Ideational Praxis Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Ideational Praxis Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in ADAS-Cog-14 Maze Task Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Maze Task Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in ADAS-Cog-14 Number Cancellation Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Number Cancellation Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in ADAS-Cog-14 Naming Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Naming Score of the ADAS-Cog-14 ranges from 0 to 5 with a higher score representing greater impairment. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in ADAS-Cog-14 Orientation Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Orientation Score of the ADAS-Cog-14 ranges from 0 to 8, with a higher score representing greater impairment. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in ADAS-Cog-14 Word Recall - Number of Words Not Recalled Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Recall - Number of Words Not Recalled Score of the ADAS-Cog-14 ranges from 0 to 10, with a higher score representing greater impairment. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in ADAS-Cog-14 Remember Word Recognition Instructions Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Remember Word Recognition Instructions Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in ADAS-Cog-14 Spoken Language Ability Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Spoken Language Ability Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in ADAS-Cog-14 Word Find Difficulty Spontaneous Speech Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Find Difficulty Spontaneous Speech Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in ADAS-Cog-14 Word Recognition Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Recognition Score of the ADAS-Cog-14 ranges from 0 to 12, with a higher score representing greater impairment. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in Functional Activities Questionnaire (FAQ) Score | The FAQ measures level of assistance (functional disability) needed for carrying out instrumental activities in daily living (iADLs). The FAQ score ranges from 0 - 30 and consists of 10 items (each scored from 0 - 3), which measure a specific iADL in the past 4-weeks: [1) writing checks, paying bills, keeping financial records; 2) assembling tax or business records; 3) shopping alone; 4) playing a game of skill; 5) making coffee or tea; 6) preparing a balanced meal; 7) keeping track of current events; 8) attending to and understanding a television program, book, or magazine; 9) remembering appointments, family occasions, medications; and 10) traveling out of the neighborhood]. Performance in each category is rated from 0 - 3 as follows: 0 - normal; 1 - has difficulty, but does by self; 2 - requires assistance; or 3 - dependent. The FAQ was administered by a trained interviewer. Higher scores indicate a greater requirement of assistance. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI) General Condition Score | The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning. Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening. | Baseline, Week 48, Week 96 |
| Change From Baseline Over Time in ADCS-CGIC-MCI Cognition Score | The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning. Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening. | Baseline, Week 48, Week 96 |
| Change From Baseline Over Time in ADCS-CGIC-MCI Behavior Score | The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning. Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening. | Baseline, Week 48, Week 96 |
| Change From Baseline Over Time in ADCS-CGIC-MCI Functional Abilities Score | The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning (functional abilities). Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening. | Baseline, Week 48, Week 96 |
| Change From Baseline Over Time in University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) - Total Score | The UPSA-Brief is a performance-based instrument which uses a series of tasks and roleplay scenarios to evaluate a person's functional capacity in two areas of basic living skills (i.e., financial skills and communication skills). Scores range from 0 to 100; a higher score of the UPSA-Brief is desirable. | Baseline, Week 48, Week 96 |
| Change From Baseline Over Time in 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients With Mild Cognitive Impairment (ADCS-MCI-ADL-24) Total Score | The ADCS-MCI-ADL-24 is a 24-item, study partner-based assessment of activities of daily living designed specifically for AD patients and is completed by a trained rater. The scale assesses functional activities such as cooking, household chores, shopping, keeping appointments, social interactions and hobbies. Items are assessed according to whether they were performed in the past 4 weeks and, if so, some items are further assessed as to whether they were performed independently, with supervision, or with physical help. Scores on the ADCS-ADL-MCI range from 0 to 69, where higher score indicates greater capability to carry out activities of daily living. | Baseline, Week 48, Week 96 |
| Change From Baseline Over Time in Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - Total Scale Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. Total score can range from 40 to 160 with a higher score representing a better outcome. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in RBANS - Coding Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Coding Total Score of the RBANS ranges from 0 to 89, with a higher score representing a better outcome. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in RBANS - Digit Span Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Digit Span Total Score of the RBANS ranges from 0 to 8, with a higher score representing a better outcome. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in RBANS - Figure Copy Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Figure Copy Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in RBANS - Figure Recall Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Figure Recall Total Score of the RBANS ranges from 0 to 18, with a higher score representing a better outcome. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in RBANS - List Recognition Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Recognition Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in RBANS - List Learning Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Learning Total Score of the RBANS ranges from 0 to 40, with a higher score representing a better outcome. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in RBANS - Line Orientation Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Line Orientation Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in RBANS - List Recall Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Recall Total Score of the RBANS ranges from 0 to 10, with a higher score representing a better outcome. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in RBANS - Picture Naming Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Picture Naming Total Score of the RBANS ranges from 0 to 10, with a higher score representing a better outcome. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in RBANS - Semantic Fluency Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Semantic Fluency Total Score of the RBANS ranges from 0 to 40, with a higher score representing a better outcome. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in RBANS - Story Memory Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Story Memory Total Score of the RBANS ranges from 0 to 24, with a higher score representing a better outcome. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in RBANS - Story Recall Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Story Recall Total Score of the RBANS ranges from 0 to 12, with a higher score representing a better outcome. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Total Score | The MMSE is a brief, 30-point questionnaire, administered by a trained rater, which provides a quantitative measure of cognitive status in adults and is widely used to screen for cognitive impairment and to estimate the severity of cognitive impairment at a given point in time in AD participants. The MMSE ranges from 0 to 30, with lower scores indicating greater impairment. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in Neuropsychiatry Inventory (NPI) Total Score | The NPI is used to assess changes in the participant's behavior that occurred in a defined period of time (4 weeks). The NPI assesses 12 behavioral domains on the dimensions of frequency and severity. Frequency is rated on a scale where 0 = absent, 1 = occasionally, 2 = often, 3 = frequently, 4 = very frequently. Severity is rated on a scale where 0 = absent, 1 = mild, 2 = moderate, 3 = severe. For each of the domains, 3 scores are obtained: frequency, severity, and total (product of frequency and severity; ranges from 0 to 12, with a lower score desirable). A total NPI score can be calculated by summing the domain total scores. Total Score ranges from 0 to 144 with a lower score desirable. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Change From Baseline Over Time in Alzheimer's Disease Composite Score (ADCOMS) Score | ADCOMS score is a composite score which is a weighted linear combination of the selected individual scale items from ADAS-Cog-14 (see description in Outcome Measure 10) , MMSE (see description in Outcome Measure 45), and CDR-SB (see description in Outcome Measure 1) scales. The ADCOMS score ranges from 0 to 1.97, with a lower score desirable. | Baseline, Week 24, Week 48, Week 72, Week 96 |
| Banner Sun Health Res Inst /ID# 151895 |
| Sun City |
| Arizona |
| 85351 |
| United States |
| Irvine Clinical Research /ID# 162331 | Irvine | California | 92614 | United States |
| Ucsd /Id# 152467 | La Jolla | California | 92037 | United States |
| Ray Dolby Brain Health Center /ID# 154965 | San Francisco | California | 94113 | United States |
| Univ California, San Francisco /ID# 152053 | San Francisco | California | 94143-2204 | United States |
| Brain Matters Research /ID# 147796 | Delray Beach | Florida | 33445 | United States |
| Neuropsychiatric Research Center of Southwest Florida /ID# 162332 | Fort Myers | Florida | 33912 | United States |
| Mayo Clinic /ID# 151236 | Jacksonville | Florida | 32224 | United States |
| Synexus Clinical Research US, Inc. /ID# 147804 | Orlando | Florida | 32806-1044 | United States |
| University of South Florida /ID# 151890 | Tampa | Florida | 33612 | United States |
| Synexus Clinical Research US, Inc /ID# 151633 | The Villages | Florida | 32162-7116 | United States |
| Emory Midtown Infectious Disease Clinic /ID# 151492 | Atlanta | Georgia | 30322 | United States |
| Atlanta Center for Medical Research /ID# 151550 | Atlanta | Georgia | 30331 | United States |
| NeuroStudies.net, LLC /ID# 152746 | Decatur | Georgia | 30030 | United States |
| Great Lakes Clinical Trials /ID# 152754 | Chicago | Illinois | 60640 | United States |
| Advocate Lutheran General Hospital /ID# 152052 | Park Ridge | Illinois | 60068 | United States |
| Southern IL Univ School of Med /ID# 151769 | Springfield | Illinois | 62702 | United States |
| Indiana University /ID# 151861 | Indianapolis | Indiana | 46202 | United States |
| University of Kansas Medical Center - Alzheimer's Disease Center /ID# 151554 | Fairway | Kansas | 66205 | United States |
| University of Kentucky Chandler Medical Center /ID# 152753 | Lexington | Kentucky | 40536 | United States |
| Johns Hopkins Bayview Med Cnt /ID# 151893 | Baltimore | Maryland | 21224 | United States |
| Massachusetts General Hospital /ID# 151770 | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Physicians /ID# 151882 | Boston | Massachusetts | 02115 | United States |
| Hattiesburg Clinic /ID# 202388 | Hattiesburg | Mississippi | 39401 | United States |
| Princeton Medical Institute /ID# 152934 | Princeton | New Jersey | 08540 | United States |
| Scott Research Inc. /ID# 151880 | Laurelton | New York | 11413 | United States |
| North Shore University Hospital /ID# 151632 | New Hyde Park | New York | 11040 | United States |
| Duke Cancer Center /ID# 147828 | Durham | North Carolina | 27710-3000 | United States |
| Oregon Health and Science University /ID# 151690 | Portland | Oregon | 97239 | United States |
| Keystone Clinical Studies LLC /ID# 202305 | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Rhode Island Hospital /ID# 151538 | Providence | Rhode Island | 02903 | United States |
| Vanderbilt University Medical Center /ID# 154547 | Nashville | Tennessee | 37232-0011 | United States |
| Kerwin Research Center /ID# 147815 | Dallas | Texas | 75231-4316 | United States |
| Houston Methodist Hospital /ID# 154810 | Houston | Texas | 77030 | United States |
| McGovern Medical School /ID# 204860 | Houston | Texas | 77054 | United States |
| University of Utah /ID# 151858 | Salt Lake City | Utah | 84112-5500 | United States |
| Integrated Neurology Services /ID# 154863 | Alexandria | Virginia | 22310 | United States |
| The Kinghorn Cancer Centre /ID# 152632 | Darlinghurst | New South Wales | 2010 | Australia |
| Griffith University /ID# 152635 | Southport | Queensland | 4222 | Australia |
| Austin Health /ID# 152637 | Heidelberg | Victoria | 3084 | Australia |
| The Royal Melbourne Hospital /ID# 202633 | Parkville | Victoria | 3050 | Australia |
| Australian Alzheimer's Res Fou /ID# 152634 | Nedlands | Western Australia | 6009 | Australia |
| Neurodegenerative Disorders Research /ID# 152826 | West Perth | Western Australia | 6005 | Australia |
| UCL Saint-Luc /ID# 152847 | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium |
| Universitair Ziekenhuis Leuven /ID# 152642 | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Groupe Sante CHC - Clinique du MontLegia /ID# 152846 | Liège | 4000 | Belgium |
| Parkwood Institute /ID# 164204 | London | Ontario | N6C 0A7 | Canada |
| Toronto Memory Program /ID# 147863 | Toronto | Ontario | M3B 2S7 | Canada |
| Rigshospitalet /ID# 153192 | Copenhagen Ø | Capital Region | 2100 | Denmark |
| Clinical Research Services Turku /ID# 152845 | Turku | Southwest Finland | 20520 | Finland |
| Ita-Suomen Yliopisto /ID# 152959 | Kuopio | 70210 | Finland |
| AOU di Modena /ID# 152394 | Modena | Emilia-Romagna | 41126 | Italy |
| Policlinico Agostino Gemelli /ID# 152396 | Rome | Lazio | 00168 | Italy |
| Duplicate_AOU Policlinico Umberto I /ID# 163144 | Rome | Lazio | 00185 | Italy |
| Azienda Ospedaliera di Perugia /ID# 152397 | Perugia | Umbria | 06129 | Italy |
| IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli /ID# 152395 | Brescia | 25125 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152401 | Milan | 20122 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda /ID# 152391 | Milan | 20162 | Italy |
| Universitair Medisch Centrum Utrecht /ID# 163576 | Utrecht | 3584 CX | Netherlands |
| CGM Research Trust /ID# 152827 | Burwood | 8083 | New Zealand |
| Fundacion CITA Alzheimer Fundazioa /ID# 152645 | Donostia / San Sebastian | Basque Country | 20009 | Spain |
| Fundacio ACE /ID# 152643 | Barcelona | 08028 | Spain |
| Hospital Clinic de Barcelona /ID# 152646 | Barcelona | 08036 | Spain |
| Hospital Clinico Universitario San Carlos /ID# 153703 | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre /ID# 152647 | Madrid | 28041 | Spain |
| Karolinska University Hospital Huddinge /ID# 156705 | Stockholm | Stockholm County | 171 77 | Sweden |
| Sahlgrenska University Hospital Molndal /ID# 154465 | Mölndal | Västra Götaland County | 431 80 | Sweden |
| FG002 | ABBV-8E12 1000 mg | ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| FG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
| COMPLETED |
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| NOT COMPLETED |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo for ABBV-8E12 every 4 weeks for 96 weeks |
| BG001 | ABBV-8E12 300 mg | ABBV-8E12 300 mg every 4 weeks for 96 weeks |
| BG002 | ABBV-8E12 1000 mg | ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| BG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score | The CDR-SB is a numeric scale used to quantify the severity of symptoms of dementia. A qualified health professional assesses a participant's cognitive and functional performance in 6 areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The CDR scale gives a score from 0 to 3 for each of the 6 areas, with a lower value being desirable. The sum of these 6 areas, the CDR-SB score, can range from 0 to 18, with a lower value being desirable. | Mean | Standard Deviation | score on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline Over Time in CDR-SB Score | The CDR-SB is a numeric scale used to quantify the severity of symptoms of dementia. A qualified health professional assesses a participant's cognitive and functional performance in 6 areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The CDR scale gives a score from 0 to 3 for each of the 6 areas, with a lower value being desirable. The sum of these 6 areas, the CDR-SB score, can range from 0 to 18, with a lower value being desirable. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | A TEAE was defined as an adverse event (AE) that began on or after the first study drug dose date and no more than 20 weeks after the last dose of study drug. An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. Serious AEs (SAEs) were defined as an event that results in death, is life-threatening, results in hospitalization or prolongs hospitalization, is a congenital abnormality, results in persistent or significant disability/incapacity, or is an important medical event. Events were rated in severity as mild, moderate, or severe, and were categorized as having a reasonable possibility or no reasonable possibility of relationship to study drug. | Safety Dataset: participants who received at least 1 dose of study drug. | Posted | Number | participants | From first dose of study drug up to last dose of study drug plus 20 weeks (up to Week 112) |
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| Secondary | Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses | Intensive Pharmacokinetic Cohort: Among the first 48 participants enrolled in the study, those who received ABBV-8E12 and had an evaluable PK assessment at given time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99. |
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| Secondary | Time to Cmax (Tmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses | Intensive Pharmacokinetic Cohort: Among the first 48 participants enrolled in the study, those who received ABBV-8E12 and had an evaluable PK assessment at given time point. | Posted | Median | Full Range | hours | Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99. |
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| Secondary | Serum Concentration at the End of a Dose Interval (Ctrough) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses | Intensive Pharmacokinetic Cohort: Among the first 48 participants enrolled in the study, those who received ABBV-8E12 and had an evaluable PK assessment at given time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99. |
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| Secondary | Half-Life (T1/2) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses | Harmonic mean is presented in the data table. | Intensive Pharmacokinetic Cohort: Among the first 48 participants enrolled in the study, those who received ABBV-8E12 and had an evaluable PK assessment at given time point. | Posted | Mean | Standard Deviation | days | Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99. |
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| Secondary | Area Under the Concentration-Time Curve From Dosing (Time 0) to Day 28 (AUC0-28) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses |
| Intensive Pharmacokinetic Cohort: Among the first 48 participants enrolled in the study, those who received ABBV-8E12 and had an evaluable PK assessment at given time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg.day/mL | Day 1 (Dose 1): pre-infusion, up to Day 29 (trough level before Dose 2). Day 85 (Dose 4): pre-infusion, up to Day 113 (trough level before Dose 5). See Outcome Measure description above for complete time point details. |
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| Secondary | Cmax/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses | Intensive Pharmacokinetic Cohort: Among the first 48 participants enrolled in the study, those who received ABBV-8E12 and had an evaluable PK assessment at given time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL/mg | Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99. |
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| Secondary | AUC0-28/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses |
| Intensive Pharmacokinetic Cohort: Among the first 48 participants enrolled in the study, those who received ABBV-8E12 and had an evaluable PK assessment at given time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg.day/mL/mg | Day 1 (Dose 1): pre-infusion, up to Day 29 (trough level before Dose 2). Day 85 (Dose 4): pre-infusion, up to Day 113 (trough level before Dose 5). See Outcome Measure description above for complete time point details. |
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| Secondary | Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) Total Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in mild cognitive impairment (MCI) patients. The Total Score of the ADAS-Cog-14 ranges from 0 to 90, with a higher score representing greater impairment. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Comprehension of Spoken Language score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Constructional Praxis Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in ADAS-Cog-14 Commands Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Commands Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in ADAS-Cog-14 Delayed Word Recall Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Delayed Word Recall Score of the ADAS-Cog-14 ranges from 0 to 10, with a higher score representing greater impairment. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in ADAS-Cog-14 Ideational Praxis Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Ideational Praxis Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in ADAS-Cog-14 Maze Task Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Maze Task Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in ADAS-Cog-14 Number Cancellation Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Number Cancellation Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in ADAS-Cog-14 Naming Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Naming Score of the ADAS-Cog-14 ranges from 0 to 5 with a higher score representing greater impairment. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in ADAS-Cog-14 Orientation Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Orientation Score of the ADAS-Cog-14 ranges from 0 to 8, with a higher score representing greater impairment. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in ADAS-Cog-14 Word Recall - Number of Words Not Recalled Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Recall - Number of Words Not Recalled Score of the ADAS-Cog-14 ranges from 0 to 10, with a higher score representing greater impairment. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in ADAS-Cog-14 Remember Word Recognition Instructions Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Remember Word Recognition Instructions Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in ADAS-Cog-14 Spoken Language Ability Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Spoken Language Ability Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in ADAS-Cog-14 Word Find Difficulty Spontaneous Speech Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Find Difficulty Spontaneous Speech Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in ADAS-Cog-14 Word Recognition Score | The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Recognition Score of the ADAS-Cog-14 ranges from 0 to 12, with a higher score representing greater impairment. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in Functional Activities Questionnaire (FAQ) Score | The FAQ measures level of assistance (functional disability) needed for carrying out instrumental activities in daily living (iADLs). The FAQ score ranges from 0 - 30 and consists of 10 items (each scored from 0 - 3), which measure a specific iADL in the past 4-weeks: [1) writing checks, paying bills, keeping financial records; 2) assembling tax or business records; 3) shopping alone; 4) playing a game of skill; 5) making coffee or tea; 6) preparing a balanced meal; 7) keeping track of current events; 8) attending to and understanding a television program, book, or magazine; 9) remembering appointments, family occasions, medications; and 10) traveling out of the neighborhood]. Performance in each category is rated from 0 - 3 as follows: 0 - normal; 1 - has difficulty, but does by self; 2 - requires assistance; or 3 - dependent. The FAQ was administered by a trained interviewer. Higher scores indicate a greater requirement of assistance. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI) General Condition Score | The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning. Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 48, Week 96 |
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| Secondary | Change From Baseline Over Time in ADCS-CGIC-MCI Cognition Score | The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning. Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 48, Week 96 |
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| Secondary | Change From Baseline Over Time in ADCS-CGIC-MCI Behavior Score | The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning. Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 48, Week 96 |
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| Secondary | Change From Baseline Over Time in ADCS-CGIC-MCI Functional Abilities Score | The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning (functional abilities). Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 48, Week 96 |
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| Secondary | Change From Baseline Over Time in University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) - Total Score | The UPSA-Brief is a performance-based instrument which uses a series of tasks and roleplay scenarios to evaluate a person's functional capacity in two areas of basic living skills (i.e., financial skills and communication skills). Scores range from 0 to 100; a higher score of the UPSA-Brief is desirable. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 48, Week 96 |
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| Secondary | Change From Baseline Over Time in 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients With Mild Cognitive Impairment (ADCS-MCI-ADL-24) Total Score | The ADCS-MCI-ADL-24 is a 24-item, study partner-based assessment of activities of daily living designed specifically for AD patients and is completed by a trained rater. The scale assesses functional activities such as cooking, household chores, shopping, keeping appointments, social interactions and hobbies. Items are assessed according to whether they were performed in the past 4 weeks and, if so, some items are further assessed as to whether they were performed independently, with supervision, or with physical help. Scores on the ADCS-ADL-MCI range from 0 to 69, where higher score indicates greater capability to carry out activities of daily living. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 48, Week 96 |
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| Secondary | Change From Baseline Over Time in Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - Total Scale Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. Total score can range from 40 to 160 with a higher score representing a better outcome. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in RBANS - Coding Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Coding Total Score of the RBANS ranges from 0 to 89, with a higher score representing a better outcome. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in RBANS - Digit Span Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Digit Span Total Score of the RBANS ranges from 0 to 8, with a higher score representing a better outcome. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in RBANS - Figure Copy Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Figure Copy Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in RBANS - Figure Recall Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Figure Recall Total Score of the RBANS ranges from 0 to 18, with a higher score representing a better outcome. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in RBANS - List Recognition Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Recognition Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in RBANS - List Learning Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Learning Total Score of the RBANS ranges from 0 to 40, with a higher score representing a better outcome. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in RBANS - Line Orientation Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Line Orientation Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in RBANS - List Recall Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Recall Total Score of the RBANS ranges from 0 to 10, with a higher score representing a better outcome. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in RBANS - Picture Naming Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Picture Naming Total Score of the RBANS ranges from 0 to 10, with a higher score representing a better outcome. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in RBANS - Semantic Fluency Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Semantic Fluency Total Score of the RBANS ranges from 0 to 40, with a higher score representing a better outcome. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in RBANS - Story Memory Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Story Memory Total Score of the RBANS ranges from 0 to 24, with a higher score representing a better outcome. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline Over Time in RBANS - Story Recall Total Score | The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Story Recall Total Score of the RBANS ranges from 0 to 12, with a higher score representing a better outcome. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Total Score | The MMSE is a brief, 30-point questionnaire, administered by a trained rater, which provides a quantitative measure of cognitive status in adults and is widely used to screen for cognitive impairment and to estimate the severity of cognitive impairment at a given point in time in AD participants. The MMSE ranges from 0 to 30, with lower scores indicating greater impairment. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at baseline and given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in Neuropsychiatry Inventory (NPI) Total Score | The NPI is used to assess changes in the participant's behavior that occurred in a defined period of time (4 weeks). The NPI assesses 12 behavioral domains on the dimensions of frequency and severity. Frequency is rated on a scale where 0 = absent, 1 = occasionally, 2 = often, 3 = frequently, 4 = very frequently. Severity is rated on a scale where 0 = absent, 1 = mild, 2 = moderate, 3 = severe. For each of the domains, 3 scores are obtained: frequency, severity, and total (product of frequency and severity; ranges from 0 to 12, with a lower score desirable). A total NPI score can be calculated by summing the domain total scores. Total Score ranges from 0 to 144 with a lower score desirable. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
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| Secondary | Change From Baseline Over Time in Alzheimer's Disease Composite Score (ADCOMS) Score | ADCOMS score is a composite score which is a weighted linear combination of the selected individual scale items from ADAS-Cog-14 (see description in Outcome Measure 10) , MMSE (see description in Outcome Measure 45), and CDR-SB (see description in Outcome Measure 1) scales. The ADCOMS score ranges from 0 to 1.97, with a lower score desirable. | Intent-to-Treat Data Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24, Week 48, Week 72, Week 96 |
|
From the time of study drug administration until 20 weeks following discontinuation of study drug administration. Overall median time on study was 680.0 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo for ABBV-8E12 every 4 weeks for 96 weeks | 1 | 116 | 26 | 116 | 83 | 116 |
| EG001 | ABBV-8E12 300 mg | ABBV-8E12 300 mg every 4 weeks for 96 weeks | 2 | 108 | 19 | 108 | 68 | 108 |
| EG002 | ABBV-8E12 1000 mg | ABBV-8E12 1000 mg every 4 weeks for 96 weeks | 2 | 116 | 22 | 116 | 86 | 116 |
| EG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks | 1 | 113 | 17 | 113 | 91 | 113 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ARTERIOSCLEROSIS CORONARY ARTERY | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MYOCARDITIS | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RIGHT VENTRICULAR FAILURE | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SINUS NODE DYSFUNCTION | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| GASTRIC ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| STOMACH MASS | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ENDOCARDITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| EPIGLOTTITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CHEST INJURY | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| MULTIPLE INJURIES | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMOTHORAX TRAUMATIC | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| SKIN LACERATION | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| SOFT TISSUE INJURY | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| TRAUMATIC INTRACRANIAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ATLANTOAXIAL SUBLUXATION | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CERVICAL SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| BREAST CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| GASTROINTESTINAL STROMAL TUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| PROSTATIC ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CEREBRAL MASS EFFECT | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEMENTIA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEMENTIA ALZHEIMER'S TYPE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MOTOR NEURONE DISEASE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NORMAL PRESSURE HYDROCEPHALUS | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| THALAMUS HAEMORRHAGE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| AGGRESSION | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| AGITATION | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PSYCHOTIC DISORDER DUE TO A GENERAL MEDICAL CONDITION | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| POLYURIA | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SEASONAL ALLERGY | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| SKIN ABRASION | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| SKIN LACERATION | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CEREBRAL MICROHAEMORRHAGE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2020 | Jul 5, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D020774 | Pick Disease of the Brain |
| D003704 | Dementia |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D008569 | Memory Disorders |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D057180 | Frontotemporal Dementia |
| D057174 | Frontotemporal Lobar Degeneration |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628586 | tilavonemab |
Not provided
Not provided
Not provided
| >= 65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| None |
|
|
| Change to Week 48 |
|
|
| Change to Week 72 |
|
|
| Change to Week 96 |
|
|
Week 24 |
| Effect size/pooled SD |
| -0.04 |
| Standard Deviation |
| 1.38 |
| 2-Sided |
Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit. |
| Superiority |
| Week 24 | repeated measures model | 0.367 | The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline*visit + treatment*visit; variance-covariance structure = Unstructured. | LS Mean of Difference | -0.16 | Standard Error of the Mean | 0.176 | 2-Sided | 95 | -0.504 | 0.187 | Superiority |
| Week 24 | Effect size/pooled SD | 0.12 | Standard Deviation | 1.33 | 2-Sided | Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit. | Superiority |
| Week 24 | repeated measures model | 0.843 | The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline*visit + treatment*visit; variance-covariance structure = Unstructured. | LS Mean of Difference | 0.04 | Standard Error of the Mean | 0.180 | 2-Sided | 95 | -0.318 | 0.389 | Superiority |
| Week 24 | Effect size/pooled SD | -0.03 | Standard Deviation | 1.37 | 2-Sided | Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit. | Superiority |
| Week 48 | repeated measures model | 0.703 | The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline*visit + treatment*visit; variance-covariance structure = Unstructured. | LS Mean of Difference | 0.08 | Standard Error of the Mean | 0.222 | 2-Sided | 95 | -0.351 | 0.520 | Superiority |
| Week 48 | Effect size/pooled SD | -0.05 | Standard Deviation | 1.62 | 2-Sided | Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit. | Superiority |
| Week 48 | repeated measures model | 0.947 | The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline*visit + treatment*visit; variance-covariance structure = Unstructured. | LS Mean of Difference | -0.01 | Standard Error of the Mean | 0.218 | 2-Sided | 95 | -0.442 | 0.413 | Superiority |
| Week 48 | Effect size/pooled SD | -0.01 | Standard Deviation | 1.69 | 2-Sided | Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit. | Superiority |
| Week 48 | repeated measures model | 0.732 | The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline*visit + treatment*visit; variance-covariance structure = Unstructured. | LS Mean of Difference | -0.08 | Standard Error of the Mean | 0.222 | 2-Sided | 95 | -0.514 | 0.361 | Superiority |
| Week 48 | Effect size/pooled SD | 0.05 | Standard Deviation | 1.51 | 2-Sided | Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit. | Superiority |
| Week 72 | repeated measures model | 0.939 | The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline*visit + treatment*visit; variance-covariance structure = Unstructured. | LS Mean of Difference | -0.02 | Standard Error of the Mean | 0.305 | 2-Sided | 95 | -0.623 | 0.576 | Superiority |
| Week 72 | Effect size/pooled SD | 0.01 | Standard Deviation | 2.19 | 2-Sided | Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit. | Superiority |
| Week 72 | repeated measures model | 0.872 | The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline*visit + treatment*visit; variance-covariance structure = Unstructured. | LS Mean of Difference | -0.05 | Standard Error of the Mean | 0.299 | 2-Sided | 95 | -0.637 | 0.540 | Superiority |
| Week 72 | Effect size/pooled SD | 0.02 | Standard Deviation | 2.27 | 2-Sided | Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit. | Superiority |
| Week 72 | repeated measures model | 0.773 | The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline*visit + treatment*visit; variance-covariance structure = Unstructured. | LS Mean of Difference | -0.09 | Standard Error of the Mean | 0.305 | 2-Sided | 95 | -0.688 | 0.512 | Superiority |
| Week 72 | Effect size/pooled SD | 0.04 | Standard Deviation | 2.13 | 2-Sided | Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit. | Superiority |
| Week 96 | repeated measures model | 0.848 | The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline*visit + treatment*visit; variance-covariance structure = Unstructured. | LS Mean of Difference | -0.07 | Standard Error of the Mean | 0.387 | 2-Sided | 95 | -0.834 | 0.686 | Superiority |
| Week 96 | Effect size/pooled SD | 0.03 | Standard Deviation | 2.64 | 2-Sided | Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit. | Superiority |
| Week 96 | repeated measures model | 0.869 | The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline*visit + treatment*visit; variance-covariance structure = Unstructured. | LS Mean of Difference | -0.06 | Standard Error of the Mean | 0.380 | 2-Sided | 95 | -0.810 | 0.684 | Superiority |
| Week 96 | Effect size/pooled SD | 0.02 | Standard Deviation | 2.75 | 2-Sided | Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit. | Superiority |
| Week 96 | repeated measures model | 0.679 | The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline*visit + treatment*visit; variance-covariance structure = Unstructured. | LS Mean of Difference | 0.16 | Standard Error of the Mean | 0.389 | 2-Sided | 95 | -0.603 | 0.925 | Superiority |
| Week 96 | Effect size/pooled SD | -0.06 | Standard Deviation | 2.72 | 2-Sided | Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit. | Superiority |
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
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|
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|
|
|
|
|
|
| ABBV-8E12 1000 mg |
ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
| OG002 | ABBV-8E12 1000 mg | ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
| OG003 |
| ABBV-8E12 2000 mg |
ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks |
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
|
|
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
| OG003 | ABBV-8E12 2000 mg | ABBV-8E12 2000 mg every 4 weeks for 96 weeks |
|
|
|
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
|
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