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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000948-42 | EudraCT Number | ||
| 54861911ALZ2003 | Other Identifier | Janssen Research & Development, LLC |
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Change in benefit-risk profile for individuals with early sporadic Alzheimer Disease because of elevations in liver enzymes in subjects receiving atabecestat
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The purpose of this study is to evaluate whether treatment with atabecestat slows cognitive decline compared with placebo treatment, as measured by a composite cognitive measure, the Preclinical Alzheimer Cognitive Composite (PACC), in amyloid-positive participants who are asymptomatic at risk for developing Alzheimer's dementia.
This is a randomized (study drug assigned by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), multi-center (more than one hospital or medical school team work on a medical research study), placebo-controlled, parallel-group study in participants who are asymptomatic and at risk for developing Alzheimer's dementia. The study will consist of a Screening Phase (approximately 90 days), treatment Phase (54 months) and follow-up Phase (7 to 28 days). In treatment Phase eligible Participants will be randomized to receive study drug or placebo once daily for up to 4.5 years. The maximum study duration for a participant will be 58 months. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants will receive one atabecestat, 5 milligram (mg) tablet orally once daily up to 54 months. |
|
| Group 2 | Experimental | Participants will receive one atabecestat, 25 mg tablet orally once daily up to 54 months. |
|
| Group 3 | Experimental | Participants will receive one matching placebo tablet orally once daily up to 54 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atabecestat, 5 mg | Drug | One atabecestat, 5 mg tablet orally once daily up to 54 months. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Preclinical Alzheimer Cognitive Composite (PACC) Score at Endpoint (Month 24) | PACC has 4 components: Free and Cued Selective Reminding Test (0 (worst)-48 (best recall); Delayed Paragraph Recall test (Range 0 (worst)-25 (best recall); Wechsler Adult Intelligence scale: (ranges 0 [none]-135 [best performance]) and Mini Mental State Examination (Range 0 [worst] - 30 [best performance]). Component scores are transformed using an established normalization method into z-scores. Each of 4 component change scores is divided by baseline sample standard deviation (SD) of that component. These z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement. | Baseline and Endpoint (Month 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Cognitive Function Index (CFI) Score at Endpoint (Month 24) | The CFI is a modified version of the Mail-in Cognitive Function Screening Instrument, a participant- and informant-reported outcome measure developed by the Alzheimer's Disease Cooperative Study (ADCS). This assessment includes 15 questions (14 of which contribute to the total score, and 1 additional unscored item) that assess the participant's perceived ability to perform high-level functional tasks in daily-life and sense of overall cognitive functional ability. Study participants and their informants independently rate the participant's abilities. A participant-reported and an informant-reported total score is calculated which ranges from 0 to 14 (yes=1; no=0; maybe=0.5 for each question) with higher scores indicating greater impairment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33464300 | Derived | Sperling R, Henley D, Aisen PS, Raman R, Donohue MC, Ernstrom K, Rafii MS, Streffer J, Shi Y, Karcher K, Raghavan N, Tymofyeyev Y, Bogert J, Brashear HR, Novak G, Thipphawong J, Saad ZS, Kolb H, Rofael H, Sanga P, Romano G. Findings of Efficacy, Safety, and Biomarker Outcomes of Atabecestat in Preclinical Alzheimer Disease: A Truncated Randomized Phase 2b/3 Clinical Trial. JAMA Neurol. 2021 Mar 1;78(3):293-301. doi: 10.1001/jamaneurol.2020.4857. |
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Total of 557 participants were enrolled in study. Study was early terminated based on experience of significant elevations in liver enzymes in participants receiving JNJ-54861911 in this study and 54861911ALZ2004 (NCT02406027).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received a single dose of JNJ-54861911 matching placebo tablet orally once daily for up to 24 months. |
| FG001 | JNJ-54861911 (5 mg) | Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016). |
| 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 | May 25, 2018 | Dec 20, 2019 |
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| Atabecestat, 25 mg |
| Drug |
One atabecestat, 25 mg tablet orally once daily up to 54 months. |
|
| Placebo | Drug | One matching placebo tablet orally once daily up to 54 months. |
|
| Baseline and Endpoint (Month 24) |
| Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Prevention Instrument (ADCS-ADLPI) Total Score at Endpoint (Month 24) | The Alzheimer's Disease Cooperative Study - Activities of Daily Living -Prevention Instrument (ADCS-ADLPI) is a functional measure composed of 18 items that includes 15 activities of daily living rated on a 4-point scale and 3 high level function items. Study participants and their informants independently rate the participant's level of ability (with no difficulty = 3, with some difficulty = 2, with a lot of difficulty = 1, did not do/don't know = 0). Informants are additionally asked to evaluate whether activities were completed less often, required more time to complete, and if any errors were made performing the task. High-level function items are rated as "yes" or "no". The scores range from 0 to 45 with higher scores indicating less impairment. The total score is the sum of the scores of the 15 activities of daily living questions (range: 0-45) with higher scores indicating less impairment. | Baseline and Endpoint (Month 24) |
| Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score at Endpoint (Month 24) | RBANS is 20 to 25 minute battery developed for cognitive assessment, detection, and characterization of dementia. RBANS includes 12 subtests that measure following 5 indices: (1)Attention Index, composed of Digit Span and Coding; (2)Language Index, consisting of Picture Naming and Semantic Fluency subtests; (3)Visuospatial/Construction Index, made up of Figure Copy and Line Orientation subtests; (4)Immediate Memory Index, composed of List Learning and Story Memory subtests, and (5)Delayed Memory Index, consisting of List Recall, List Recognition, Story Recall, and Figure Recall subtests. Completion of RBANS yields 5 index scores based on participant performance on various subtests, as well as a composite Total Index score for battery. Total index scores range from 40 to 160, and are normalized to a mean of 100 and standard deviation (SD) of 15. Higher scores indicate less impairment. | Baseline and Endpoint (Month 24) |
| Change From Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score at Endpoint (Month 24) | The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18. Higher score indicates severe impairment. | Baseline and Endpoint (Month 24) |
| Change From Baseline in Neuropsychological Assessment Battery Daily Living Tests (NABDLTs) Score at Endpoint (Month 24) | The Neuropsychological Assessment Battery Daily Living Tests (NABDLTs) Score represent a series of performance based measures covering 5 domains (Attention, Memory, Language, Spatial, and Executive function). These are valid, clinically meaningful measures that objectively assess functional deficits. Participant performance scores on NAB subtests are summed, and then normalized to yield an index score. Index scores can range from less than or equal to (< =) 55 to greater than or equal to (> =) 145, and are normalized to a mean of 100 and standard deviation of 15. Higher scores indicate less impairment. | Baseline and Endpoint (Month 24) |
| Phoenix |
| Arizona |
| United States |
| Sun City | Arizona | United States |
| Downey | California | United States |
| La Jolla | California | United States |
| Newport Beach | California | United States |
| Orange | California | United States |
| San Diego | California | United States |
| New Haven | Connecticut | United States |
| Washington D.C. | District of Columbia | United States |
| Delray Beach | Florida | United States |
| Fort Myers | Florida | United States |
| Jacksonville | Florida | United States |
| Lake Worth | Florida | United States |
| Melbourne | Florida | United States |
| Miami Beach | Florida | United States |
| Ocoee | Florida | United States |
| Orlando | Florida | United States |
| Ormond Beach | Florida | United States |
| Tampa | Florida | United States |
| The Villages | Florida | United States |
| Atlanta | Georgia | United States |
| Columbus | Georgia | United States |
| Decatur | Georgia | United States |
| Arlington Heights | Illinois | United States |
| Chicago | Illinois | United States |
| Elk Grove Village | Illinois | United States |
| Elkhart | Indiana | United States |
| Indianapolis | Indiana | United States |
| Iowa City | Iowa | United States |
| Westwood | Kansas | United States |
| Lexington | Kentucky | United States |
| Baton Rouge | Louisiana | United States |
| Bangor | Maine | United States |
| Boston | Massachusetts | United States |
| Plymouth | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| Kalamazoo | Michigan | United States |
| Hattiesburg | Mississippi | United States |
| St Louis | Missouri | United States |
| Las Vegas | Nevada | United States |
| Amherst | New York | United States |
| New York | New York | United States |
| Orangeburg | New York | United States |
| Rochester | New York | United States |
| Staten Island | New York | United States |
| Syracuse | New York | United States |
| Charlotte | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cleveland | Ohio | United States |
| Portland | Oregon | United States |
| Willow Grove | Pennsylvania | United States |
| Providence | Rhode Island | United States |
| Charleston | South Carolina | United States |
| Cordova | Tennessee | United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| Charlottesville | Virginia | United States |
| Seattle | Washington | United States |
| Spokane | Washington | United States |
| Madison | Wisconsin | United States |
| Adelaide | Australia |
| Brisbane | Australia |
| Darlinghurst | Australia |
| East Gosford | Australia |
| Heidelberg | Australia |
| Herston | Australia |
| Subiaco | Australia |
| Tarren Point | Australia |
| Waratah | Australia |
| Antwerp | Belgium |
| Baudour | Belgium |
| Brussels | Belgium |
| Edegem | Belgium |
| Liège | Belgium |
| Mons | Belgium |
| Toronto | Ontario | Canada |
| Gatineau | Quebec | Canada |
| Aalborg | Denmark |
| Ballerup Municipality | Denmark |
| København Ø | Denmark |
| Rødovre Municipality | Denmark |
| Kuopio | Finland |
| Turku | Finland |
| Berlin | Germany |
| Essen | Germany |
| Halle | Germany |
| Homburg | Germany |
| Kiel | Germany |
| Mannheim | Germany |
| Mittweida | Germany |
| Stuttgart | Germany |
| Ulm | Germany |
| Chiba | Japan |
| Fukuoka | Japan |
| Hachioji-shi | Japan |
| Iizuka-shi | Japan |
| Osaka | Japan |
| Shibuya-ku | Japan |
| Shinjuku-ku | Japan |
| Shirakawa | Japan |
| Tokyo | Japan |
| Chihuahua City | Mexico |
| Monterrey | Mexico |
| San Luis Potosí City | Mexico |
| Tlalnepantla | Mexico |
| 's-Hertogenbosch | Netherlands |
| Amsterdam | Netherlands |
| Breda | Netherlands |
| Utrecht | Netherlands |
| Barcelona | Spain |
| Donostia / San Sebastian | Spain |
| Getxo | Spain |
| Madrid | Spain |
| Manresa | Spain |
| Terrassa | Spain |
| Valencia | Spain |
| Mölndal | Sweden |
| Birmingham | United Kingdom |
| Glasgow | United Kingdom |
| Guildford | United Kingdom |
| London | United Kingdom |
| Newcastle upon Tyne | United Kingdom |
| Plymouth | United Kingdom |
| Swindon | United Kingdom |
| FG002 | JNJ-54861911 (25 mg) | Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat analysis set included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received a single dose of JNJ-54861911 matching placebo tablet orally once daily for up to 24 months. |
| BG001 | JNJ-54861911 (5 mg) | Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016). |
| BG002 | JNJ-54861911 (25 mg) | Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months. |
| BG003 | 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/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 Preclinical Alzheimer Cognitive Composite (PACC) Score at Endpoint (Month 24) | PACC has 4 components: Free and Cued Selective Reminding Test (0 (worst)-48 (best recall); Delayed Paragraph Recall test (Range 0 (worst)-25 (best recall); Wechsler Adult Intelligence scale: (ranges 0 [none]-135 [best performance]) and Mini Mental State Examination (Range 0 [worst] - 30 [best performance]). Component scores are transformed using an established normalization method into z-scores. Each of 4 component change scores is divided by baseline sample standard deviation (SD) of that component. These z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement. | Intent to treat (ITT) analysis set (all randomized participants) with participants in whom PACC change score is non-missing at greater than or equal to (>=) 1 post-baseline time point. | Posted | Mean | Standard Deviation | z-score | Baseline and Endpoint (Month 24) |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cognitive Function Index (CFI) Score at Endpoint (Month 24) | The CFI is a modified version of the Mail-in Cognitive Function Screening Instrument, a participant- and informant-reported outcome measure developed by the Alzheimer's Disease Cooperative Study (ADCS). This assessment includes 15 questions (14 of which contribute to the total score, and 1 additional unscored item) that assess the participant's perceived ability to perform high-level functional tasks in daily-life and sense of overall cognitive functional ability. Study participants and their informants independently rate the participant's abilities. A participant-reported and an informant-reported total score is calculated which ranges from 0 to 14 (yes=1; no=0; maybe=0.5 for each question) with higher scores indicating greater impairment. | ITT analysis set included all randomized participants. Here 'N' (number of Participants Analyzed) indicates the number of participants analyzed at this outcome measure and 'n' (number analyzed) was defined as the number of participants evaluable at specified category. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and Endpoint (Month 24) |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Prevention Instrument (ADCS-ADLPI) Total Score at Endpoint (Month 24) | The Alzheimer's Disease Cooperative Study - Activities of Daily Living -Prevention Instrument (ADCS-ADLPI) is a functional measure composed of 18 items that includes 15 activities of daily living rated on a 4-point scale and 3 high level function items. Study participants and their informants independently rate the participant's level of ability (with no difficulty = 3, with some difficulty = 2, with a lot of difficulty = 1, did not do/don't know = 0). Informants are additionally asked to evaluate whether activities were completed less often, required more time to complete, and if any errors were made performing the task. High-level function items are rated as "yes" or "no". The scores range from 0 to 45 with higher scores indicating less impairment. The total score is the sum of the scores of the 15 activities of daily living questions (range: 0-45) with higher scores indicating less impairment. | ITT analysis set included all randomized participants. Here 'n' (number analyzed) was defined as the number of participants evaluable at specified category. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline and Endpoint (Month 24) |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score at Endpoint (Month 24) | RBANS is 20 to 25 minute battery developed for cognitive assessment, detection, and characterization of dementia. RBANS includes 12 subtests that measure following 5 indices: (1)Attention Index, composed of Digit Span and Coding; (2)Language Index, consisting of Picture Naming and Semantic Fluency subtests; (3)Visuospatial/Construction Index, made up of Figure Copy and Line Orientation subtests; (4)Immediate Memory Index, composed of List Learning and Story Memory subtests, and (5)Delayed Memory Index, consisting of List Recall, List Recognition, Story Recall, and Figure Recall subtests. Completion of RBANS yields 5 index scores based on participant performance on various subtests, as well as a composite Total Index score for battery. Total index scores range from 40 to 160, and are normalized to a mean of 100 and standard deviation (SD) of 15. Higher scores indicate less impairment. | ITT analysis set included all randomized participants. Here 'N' (Number of participants analyzed) was defined as the number of participants evaluable at this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and Endpoint (Month 24) |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score at Endpoint (Month 24) | The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18. Higher score indicates severe impairment. | As the study was terminated early with lesser participants and lesser sample size, data for this endpoint was not collected and analyzed per change in planned analysis. | Posted | Baseline and Endpoint (Month 24) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Neuropsychological Assessment Battery Daily Living Tests (NABDLTs) Score at Endpoint (Month 24) | The Neuropsychological Assessment Battery Daily Living Tests (NABDLTs) Score represent a series of performance based measures covering 5 domains (Attention, Memory, Language, Spatial, and Executive function). These are valid, clinically meaningful measures that objectively assess functional deficits. Participant performance scores on NAB subtests are summed, and then normalized to yield an index score. Index scores can range from less than or equal to (< =) 55 to greater than or equal to (> =) 145, and are normalized to a mean of 100 and standard deviation of 15. Higher scores indicate less impairment. | As the study was terminated early with lesser participants and lesser sample size, data for this endpoint was not collected and analyzed per change in planned analysis. | Posted | Baseline and Endpoint (Month 24) |
|
Up to 24 months
Safety analysis set included all randomized participants who have received at least one study medication.
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 | Participants received a single dose of JNJ-54861911 matching placebo tablet orally once daily for up to 24 months. | 0 | 185 | 9 | 185 | 80 | 185 |
| EG001 | JNJ-54861911 (5 mg) | Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016). | 0 | 189 | 18 | 189 | 75 | 189 |
| EG002 | JNJ-54861911 (25 mg) | Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months. | 0 | 183 | 26 | 183 | 88 | 183 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Unstable | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Retinal Detachment | Eye disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Mechanical Ileus | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Drug-Induced Liver Injury | Hepatobiliary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Poliomyelitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Fractured Ischium | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Post Lumbar Puncture Syndrome | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Adenocarcinoma of Colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Benign Ovarian Tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Breast Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Chronic Lymphocytic Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Gastrointestinal Stromal Tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Invasive Ductal Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cervical Radiculopathy | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Lumbosacral Radiculopathy | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Paralysis Recurrent Laryngeal Nerve | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Loss of Libido | Psychiatric disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Ejaculation Failure | Reproductive system and breast disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Erectile Dysfunction | Reproductive system and breast disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Asthmatic Crisis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pulmonary Mass | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Abnormal Dreams | Psychiatric disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
|
Early termination of study/program due to a change in benefit-risk profile for individuals with early sporadic AD because of elevations in liver enzymes in participants receiving JNJ-54861911.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2018 | Dec 20, 2019 | SAP_001.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000634126 | atabecestat |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Hispanic or Latino |
|
| Other |
|
| White Non-Hispanic |
|
| BELGIUM |
|
| CANADA |
|
| DENMARK |
|
| FINLAND |
|
| GERMANY |
|
| ITALY |
|
| JAPAN |
|
| MEXICO |
|
| NETHERLANDS |
|
| SPAIN |
|
| SWEDEN |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
| OG002 | JNJ-54861911 (25 mg) | Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months. |
|
|
Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016).
| OG002 | JNJ-54861911 (25 mg) | Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months. |
|
|
Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016).
| OG002 | JNJ-54861911 (25 mg) | Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months. |
|
|
Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months. |
|
| OG002 | JNJ-54861911 (25 mg) | Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months. |
|