An Efficacy and Safety Study of JNJ-54861911 in Participants Who Are Asymptomatic at Risk for Developing Alzheimer's Dementia (EARLY)
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|ClinicalTrials.gov Identifier: NCT02569398|
Recruitment Status : Recruiting
First Posted : October 6, 2015
Last Update Posted : March 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Asymptomatic Amyloid-positive||Drug: JNJ-54861911, 5 mg Drug: JNJ-54861911, 25 mg Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1650 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Study Investigating the Efficacy and Safety of JNJ-54861911 in Subjects Who Are Asymptomatic At Risk for Developing Alzheimer's Dementia|
|Actual Study Start Date :||November 23, 2015|
|Estimated Primary Completion Date :||April 10, 2024|
|Estimated Study Completion Date :||April 10, 2024|
Experimental: Group 1
Participants will receive one JNJ-54861911, 5 milligram (mg) tablet orally once daily up to 54 months.
Drug: JNJ-54861911, 5 mg
One JNJ-54861911, 5 mg tablet orally once daily up to 54 months.
Experimental: Group 2
Participants will receive one JNJ-54861911, 25 mg tablet orally once daily up to 54 months.
Drug: JNJ-54861911, 25 mg
One JNJ-54861911, 25 mg tablet orally once daily up to 54 months.
Experimental: Group 3
Participants will receive one matching placebo tablet orally once daily up to 54 months.
One matching placebo tablet orally once daily up to 54 months.
- Change from Baseline in Preclinical Alzheimer Cognitive Composite (PACC) to Month 54 [ Time Frame: Up to Month 54 ]The PACC is composed of 4 measures [Free and Cued Selective Reminding Test, Delayed Paragraph Recall, Wechsler Adult Intelligence Scale (WAIS)-IV Coding and Mini Mental State Examination (MMSE) Total Score] that are weighted towards episodic memory and includes a timed executive function test and a global cognitive screening test. Each component score will be transformed into z scores. These z-scores will then be summed to form the composite. Higher scores indicate better performance.
- Change from Baseline in Cognitive Function Index (CFI) to Month 54 [ Time Frame: Up to Month 54 ]Cognitive Function Index (CFI) is a 15 point rating scale that assess the Participants perceived ability to perform high-level functional tasks in daily-life and sense of overall cognitive functional ability. The higher scores indicates greater impairment.
- Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Prevention Instrument (ADCS-ADLPI) Total Score to Month 54 [ Time Frame: Up to Month 54 ]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. The scores range from 0 to 45 with higher scores indicating less impairment.
- Change from Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score to Month 51 [ Time Frame: Up to Month 51 ]The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) rating scale is used to assess the cognitive assessment, detection, and characterization of dementia. The scores range from 40 to 160, and are normalized to a mean of 100 and standard deviation of 15. Higher scores indicating less impairment.
- Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score to Month 54 [ Time Frame: Up to Month 54 ]The Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores ranging from 0 to 18. The CDR assesses 3 domains of cognition (memory, orientation, judgment/problem solving) and 3 domains of function (community affairs, home/hobbies, personal care) using semistructured interviews of both the study participant and an informant carried out by a trained rater. The Higher CDR-SB scores indicate greater impairment.
- Change from Baseline in Neuropsychological Assessment Battery Daily Living Tests (NABDLTs) Score to Month 54 [ Time Frame: Up to Month 54 ]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). 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.
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Month 58 ]An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- Trough Plasma Concentration (Ctrough) of JNJ-54861911 [ Time Frame: Up to Month 54 ]The Ctrough is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.
- Area Under the Plasma Concentration-Time Curve From 0 to tau Hours After Dosing (AUCtau) [ Time Frame: Up to Month 54 ]The AUCtau is the area under the plasma concentration-time curve from time zero to tau hours (time tau is the dosing interval).
- Change in mean Cerebral Fibrillar Amyloid Accumulation [ Time Frame: Up to Month 54 ]The accumulation of cerebral fibrillar amyloid will be measured by amyloid positron emission tomography (PET) imaging.
- Change From Baseline of Neurodegeneration by Assessing Changes in Imaging Biomarkers [ Time Frame: Up to Month 54 ]Neurodegeneration will be assessed based on changes in imaging biomarkers.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569398
|Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:||JNJ.CT@sylogent.com|
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|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|