Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02260674 | A Safety and Tolerability Study of JNJ-54861911 in Participants With Early Alzheimer's Disease | PHASE2 | COMPLETED | 114 | — | — | Nov 1, 2014 | Jun 1, 2016 | Apr 29, 2025 | 19 | Belgium, France +4 |
| NCT02360657 | Study Investigating the Effects of JNJ-54861911 on Amyloid-beta Processing in Cerebrospinal Fluid (CSF) and Plasma in Japanese Participants Asymptomatic at Risk for Alzheimer Dementia | PHASE1 | COMPLETED | 18 | — | — | Feb 16, 2015 | Sep 8, 2015 | Feb 4, 2019 | 2 | Japan |
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
The Cmax is the maximum observed plasma concentration.
The Cmin is the minimum observed plasma concentration.
The Tmax is time to reach the maximum observed plasma concentration.
The AUCtau is a measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is 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.
| Arm | Type | Description |
|---|---|---|
| Treatment Group 1 | EXPERIMENTAL | Participants will self-administer JNJ-54861911, two tablets of 5 milligram (mg) each for a total of 10 mg, orally, once daily, from Day 1 until Month 6. |
| Treatment Group 2 | EXPERIMENTAL | Participants will self-administer JNJ-54861911, two tablets of 25 mg each for a total of 50 mg, orally, once daily, from Day 1 until Month 6. |
| Placebo | PLACEBO_COMPARATOR | Placebo matched to JNJ-54861911, orally, once daily, from Day 1 until Month 6. |
| JNJ-54861911, 10 mg | EXPERIMENTAL | JNJ-54861911, 10 milligram (mg) (2\*5 mg tablet) orally once daily for 4 weeks. |
| JNJ-54861911, 50 mg | EXPERIMENTAL | JNJ-54861911, 50 mg (2\*25 mg tablet) orally once daily for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| JNJ-54861911, 10 milligram (mg) | DRUG | Participants will self-administer JNJ-54861911, two tablets of 5 mg each for a total of 10 mg, orally, once daily, from Day 1 until Month 6 in treatment group 1. |
| JNJ-54861911, 50 mg | DRUG | Participants will self-administer JNJ-54861911, two tablets of 25 mg each for a total of 50 mg, orally, once daily, from Day 1 until Month 6 in treatment group 2. |
| Placebo | DRUG | Placebo matched to JNJ-54861911, orally, once daily, from Day 1 until Month 6 in placebo group. |
| JNJ-54861911, 10 mg | DRUG | JNJ-54861911, 10 mg (2\*5 mg tablet) orally once daily for 4 weeks. |
Inclusion Criteria: * Participants in the early alzheimer's disease (AD) spectrum must have a global Clinical Dementia Rating Scale( CDR) score of 0 (asymptomatic at risk for AD) to 0.5 prodromal AD (pAD) inclusive * Participants must have evidence of amyloid pathology by means of either: a) low Ce...