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An Efficacy and Safety Study of Atabecestat in Participants Who Are Asymptomatic at Risk for Developing Alzheimer's Dementia

NCT02569398 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 557

Last updated 2025-04-29

Study results available
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Summary

The purpose of this study is to evaluate whether treatment with atabecestat slows cognitive decline compared with placebo treatment, as measured by a composite cognitive measure, the Preclinical Alzheimer Cognitive Composite (PACC), in amyloid-positive participants who are asymptomatic at risk for developing Alzheimer's dementia.

Conditions

  • Asymptomatic Amyloid-positive

Interventions

DRUG

Atabecestat, 5 mg

One atabecestat, 5 mg tablet orally once daily up to 54 months.

DRUG

Atabecestat, 25 mg

One atabecestat, 25 mg tablet orally once daily up to 54 months.

DRUG

Placebo

One matching placebo tablet orally once daily up to 54 months.

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
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-29
Primary Completion
2018-12-20
Completion
2018-12-20

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • Finland
  • Germany
  • Japan
  • Mexico
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

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 NCT02569398 on ClinicalTrials.gov