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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501918-55-00 | Other Identifier | EU CTR |
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Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. This study will assess how safe and effective ABBV-552 is in treating symptoms of early AD. Adverse events, change in disease activity, how ABBV-552 moves through body of participants and the body response to ABBV-552 will be assessed.
ABBV-552 is an investigational drug being developed for the treatment of Alzheimer's disease (AD). Study doctors put the participants in 1 of 4 groups (3 active dose groups and a placebo group), called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Approximately 240 participants aged 50-90 years with mild AD will be enrolled in approximately 60 sites across the world.
Participants will receive oral ABBV-552 or placebo capsules once daily for 12 weeks and followed for 30 days after the last dose of study drug.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-552: 1 mg | Experimental | Participants will receive 1 mg of ABBV-552 once daily (QD) for 12 weeks. |
|
| ABBV-552: 5 mg | Experimental | Participants will receive 5 mg of ABBV-552 QD for 12 weeks. |
|
| ABBV-552: 15 mg | Experimental | Participants will receive 5 mg of ABBV-552 QD for 12 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive placebo for ABBV-552 QD for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-552 | Drug | Oral Capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) Score at Week 12 | 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. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
- Clinically significant and/or unstable medical conditions or any other reason that the investigator determines would interfere with participation in this study (e.g., unlikely to adhere to the study or procedures, keep appointments, or is planning to relocate during the study) or would make the participant an unsuitable candidate to receive ABBV-552.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irvine Clinical Research /ID# 250030 | Irvine | California | 92614 | United States | ||
| Alliance for Research Alliance for Wellness /ID# 246492 |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo for ABBV-552 once daily (QD) for 12 weeks. |
| FG001 | ABBV-552: 1 mg | Participants received 1 mg of ABBV-552 QD for 12 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 | Dec 13, 2023 | Aug 15, 2025 |
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| Placebo for ABBV-552 |
| Drug |
Oral Capsule |
|
| Long Beach |
| California |
| 90807 |
| United States |
| Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 248891 | Los Alamitos | California | 90720 | United States |
| New England Institute for Clinical Research /ID# 246488 | Stamford | Connecticut | 06905 | United States |
| Vertex Research Group Inc /ID# 248295 | Clermont | Florida | 34711-5037 | United States |
| Finlay Medical Research - West Palm Beach /ID# 246970 | Greenacres City | Florida | 33467-2979 | United States |
| Velocity Clinical Research - Hallandale Beach /ID# 246896 | Hallandale | Florida | 33009-4427 | United States |
| New Life Medical Research Center - Hialeah /ID# 247536 | Hialeah | Florida | 33012 | United States |
| K2 Medical Research - The Villages /ID# 250820 | Lady Lake | Florida | 32159-8975 | United States |
| Allied Biomedical Res Inst Inc /ID# 246971 | Miami | Florida | 33155 | United States |
| Ivetmar Medical Group, LLC. /ID# 247670 | Miami | Florida | 33155 | United States |
| New Horizon Research Center /ID# 248298 | Miami | Florida | 33165-3372 | United States |
| K2 Medical Research - Ocoee /ID# 251029 | Ocoee | Florida | 34761-4547 | United States |
| Health Synergy Clinical Research LLC /ID# 247726 | Okeechobee | Florida | 34972-2568 | United States |
| K2 Medical Research - Orlando - South Orlando Avenue /ID# 250904 | Orlando | Florida | 32751 | United States |
| Combined Research Orlando Phase I-IV /ID# 247697 | Orlando | Florida | 32814 | United States |
| Alzheimer's Research and Treatment Center - Stuart /ID# 246484 | Stuart | Florida | 34997-5765 | United States |
| Alzheimer's Research and Treatment Center - Wellington /ID# 246491 | Wellington | Florida | 33414 | United States |
| Conquest Research /ID# 262078 | Winter Park | Florida | 32789 | United States |
| Columbus Memory Center /ID# 249534 | Columbus | Georgia | 31909 | United States |
| Northwest Clinical Trials /ID# 248663 | Boise | Idaho | 83704 | United States |
| Indiana University Health, Inc. /ID# 248300 | Fort Wayne | Indiana | 46804 | United States |
| Josephson-Wallack-Munshower Neurology - Northeast /ID# 248554 | Indianapolis | Indiana | 46256 | United States |
| University of Kentucky Sanders-Brown Center on Aging /ID# 251139 | Lexington | Kentucky | 40504 | United States |
| NeuroMedical Clinic of Central Louisiana /ID# 246960 | Alexandria | Louisiana | 71301-3900 | United States |
| Tandem Clinical Research, LLC /ID# 246973 | Marrero | Louisiana | 70072-3156 | United States |
| Adams Clinical /ID# 248358 | Watertown | Massachusetts | 02472 | United States |
| Velocity Clinical Research, Inc /ID# 249837 | Raleigh | North Carolina | 27607 | United States |
| American Clinical Research Institute (ACRI) - Beavercreek /ID# 246930 | Beavercreek | Ohio | 45432-2886 | United States |
| NeuroScience Research Center - Canton /ID# 248552 | Canton | Ohio | 44718-2784 | United States |
| Neurology Diagnostics - South /ID# 246931 | Dayton | Ohio | 45459-4296 | United States |
| Duplicate_Summit Headlands LLC /ID# 250678 | Portland | Oregon | 97210 | United States |
| Vanderbilt Ingram Cancer Center /ID# 248801 | Nashville | Tennessee | 37232-0021 | United States |
| Kerwin Medical Center /ID# 248662 | Dallas | Texas | 75231-4316 | United States |
| ANESC Research LLC /ID# 246958 | El Paso | Texas | 79912 | United States |
| Epic Medical Research /ID# 249141 | Red Oak | Texas | 75154-3981 | United States |
| Sentara Neurology Specialists - Norfolk /ID# 248578 | Norfolk | Virginia | 23510-1065 | United States |
| St Vincent's Centre for Applied Medical Research /ID# 249843 | Darlinghurst | New South Wales | 2010 | Australia |
| Southern Neurology - Kogarah /ID# 249098 | Kogarah | New South Wales | 2217 | Australia |
| Box Hill Hospital /ID# 249095 | Box Hill | Victoria | 3128 | Australia |
| Australian Alzheimer's Res Fou /ID# 249097 | Nedlands | Western Australia | 6009 | Australia |
| Universitaetsklinikum des Saarlandes /ID# 248077 | Homburg | Saarland | 66424 | Germany |
| Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 248078 | Berlin | 12203 | Germany |
| NHO Hiroshima-Nishi Medical center /ID# 256947 | Otake-shi | Hiroshima | 739-0696 | Japan |
| Duplicate_Kawashima Neurology Clinic /ID# 253561 | Fujisawa-shi | Kanagawa | 251-0038 | Japan |
| Shonan Kamakura General Hospital /ID# 256664 | Kamakura-shi | Kanagawa | 247-8533 | Japan |
| Teikyo University Mizonokuchi Hospital /ID# 253259 | Kawasaki | Kanagawa | 213-8507 | Japan |
| Nara Medical University Hospital /ID# 252564 | Kashihara-shi | Nara | 634-8522 | Japan |
| NHO Niigata National Hospital /ID# 254207 | Kashiwazaki-shi | Niigata | 945-8585 | Japan |
| Oita University Hospital /ID# 253679 | Yufu | Oita Prefecture | 879-5503 | Japan |
| Hizen Psychiatric Center /ID# 252363 | Kanzaki-gun | Saga-ken | 842-0192 | Japan |
| Juntendo University Hospital /ID# 252373 | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| CGM Research Trust /ID# 249439 | Christchurch Central | 8011 | New Zealand |
| Hospital Universitari General de Catalunya /ID# 249100 | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
| Hospital Universitari Mútua Terrassa /ID# 248448 | Terrassa | Barcelona | 08221 | Spain |
| Hospital Universitario Marques de Valdecilla /ID# 248454 | Santander | Cantabria | 39008 | Spain |
| Clinica Universidad de Navarra - Pamplona /ID# 248415 | Pamplona | Navarre | 31008 | Spain |
| Hospital Internacional Ruber - Grupo Quiron Salud /ID# 248856 | Madrid | 28034 | Spain |
| Hospital Universitario de Salamanca /ID# 249101 | Salamanca | 37711 | Spain |
| NeuroClin Limited(Previously Glasgow Memory Clinic) /ID# 249787 | Motherwell | Lanarkshire | ML3 4UF | United Kingdom |
| Re:Cognition Health Birmingham /ID# 249796 | Birmingham | B16 8LT | United Kingdom |
| Re:Cognition Health Bristol /ID# 249795 | Bristol | BS32 4SY | United Kingdom |
| St Pancras Clinical Research /ID# 249006 | London | EC2Y 8EA | United Kingdom |
| Re:Cognition Health - London /ID# 249005 | London | W1G 9JF | United Kingdom |
| FG002 | ABBV-552: 5 mg | Participants received 5 mg of ABBV-552 QD for 12 weeks. |
| FG003 | ABBV-552: 15 mg | Participants received 5 mg of ABBV-552 QD for 12 weeks. |
| mITT Population | Modified Intend-to-Treat (mITT) Population included all randomized subjects who received at least 1 capsule of study drug and had at least 1 postbaseline ADAS-Cog 14 score. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Population includes participants who received at least 1 dose of study drug and were grouped according to treatment actually received the majority of the time, defined based on the number of days each treatment was received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo for ABBV-552 once daily (QD) for 12 weeks. |
| BG001 | ABBV-552: 1 mg | Participants received 1 mg of ABBV-552 QD for 12 weeks. |
| BG002 | ABBV-552: 5 mg | Participants received 5 mg of ABBV-552 QD for 12 weeks. |
| BG003 | ABBV-552: 15 mg | Participants received 5 mg of ABBV-552 QD for 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| ADAS-Cog 14 Score at Baseline | The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) Score was designed to assess the cognitive impairments most common in AD. It includes the original 11 items from the ADAS-Cog-11 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. | Includes mITT participants with data available for analysis. | Mean | Standard Deviation | units on a scale |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) Score at Week 12 | 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. | mITT population includes participants who received at least 1 dose of study drug, have at least 1 post baseline assessment of ADAS-Cog 14, and have data available for analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 12 |
|
|
|
|
All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time participants were followed) was 116, 116, 115.5, and 114 days for Placebo, ABBV-552:1 mg, 5 mg, and 15 mg arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo for ABBV-552 once daily (QD) for 12 weeks. | 0 | 66 | 3 | 66 | 15 | 66 |
| EG001 | ABBV-552: 1 mg | Participants received 1 mg of ABBV-552 QD for 12 weeks. | 0 | 65 | 3 | 65 | 16 | 65 |
| EG002 | ABBV-552: 5 mg | Participants received 5 mg of ABBV-552 QD for 12 weeks. | 1 | 66 | 2 | 66 | 19 | 66 |
| EG003 | ABBV-552: 15 mg | Participants received 15 mg of ABBV-552 QD for 12 weeks. | 0 | 66 | 2 | 66 | 20 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| BRUGADA SYNDROME | Congenital, familial and genetic disorders | MedDRA 26.1 | Systematic Assessment |
| |
| VERTIGO POSITIONAL | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
| |
| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| RHABDOMYOLYSIS | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 26.1 | 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 | Sep 20, 2024 | Aug 15, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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|
|
|
|
| 0.6545 |
| LS Mean of Difference |
| -0.42 |
| Standard Error of the Mean |
| 0.931 |
| 2-Sided |
| 95 |
| -2.25 |
| 1.42 |
| Superiority |
| Mixed-effect Model Repeated Measurement | 0.7860 | LS Mean of Difference | 0.25 | Standard Error of the Mean | 0.928 | 2-Sided | 95 | -1.58 | 2.08 | Superiority |