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A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Safety and Tolerability of JNJ-54861911 in Subjects With Early Alzheimer's Disease
The purpose of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 during 6 months of treatment in participants with early (predementia) alzheimer's disease (AD \[degenerative disease of the brain characterized by the insidious onset of dementia, impairment of memory, judgment, attention span, and problem solving skills are followed by severe apraxias and a global loss of cognitive abilities\]).
Details
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 114 |
| Start date | 2014-11 |
| Completion | 2016-06 |
Conditions
- Alzheimer's Disease
Interventions
- JNJ-54861911, 10 milligram (mg)
- JNJ-54861911, 50 mg
- Placebo
Primary outcomes
- Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) — up to 10 months
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.
Countries
Belgium, France, Germany, Netherlands, Spain, Sweden