MedTrace Logo

An Extension Study to Evaluate the Long-Term Safety and Tolerability of JNJ-54861911 in Participants in the Early Alzheimer's Disease Spectrum

NCT02406027 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-04-29

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 in participants in the early Alzheimer's disease (AD \[progressive brain disease that slowly destroys memory and thinking skills, and eventually even the ability to carry out the simplest tasks\]) spectrum that have completed a Phase 1b or Phase 2 clinical trial with JNJ-54861911, who are willing to continue their assigned treatment.

Conditions

  • Alzheimer Disease

Interventions

DRUG

JNJ-54861911, 10 mg

Participants will self-administer JNJ-54861911 tablet, 10 mg (2\*5 mg), orally, once daily.

DRUG

JNJ-54861911, 25 mg

Participants will self-administer 1 tablet of JNJ-54861911, containing 25 mg orally, once daily.

DRUG

Placebo

Participants will self administer placebo matching to JNJ-54861911 orally once daily.

DRUG

JNJ-54861911, 5 mg

Participants will self-administer JNJ-54861911 tablet, 5 mg, orally, once daily.

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
2015-07-02
Primary Completion
2018-06-28
Completion
2018-06-28

Countries

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

Study Locations

More Related Trials

Entities

Drugs

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 NCT02406027 on ClinicalTrials.gov