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A Safety and Tolerability Study of JNJ-54861911 in Participants With Early Alzheimer's Disease

NCT02260674 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2025-04-29

No results posted yet for this study

Summary

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 \[degenerative disease of the brain characterized by the insidious onset of dementia, impairment of memory, judgment, attention span, and problem solving skills are followed by severe apraxias and a global loss of cognitive abilities\]).

Conditions

Interventions

DRUG

JNJ-54861911, 10 milligram (mg)

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.

DRUG

JNJ-54861911, 50 mg

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.

DRUG

Placebo

Placebo matched to JNJ-54861911, orally, once daily, from Day 1 until Month 6 in placebo group.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Belgium
  • France
  • Germany
  • Netherlands
  • Spain
  • Sweden

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02260674 on ClinicalTrials.gov