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Daridorexant for Alzheimer Disease Prevention

NCT07213349 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-12-19

No results posted yet for this study

Summary

This study will evaluate whether daridorexant, a DORA sleep medication, can support brain health by promoting the clearance of proteins linked to the development and progression of Alzheimer's disease. The trial is preventive and is open to participants who do not have Alzheimer's disease dementia, regardless of whether or not they experience sleep problems.

Conditions

  • Alzheimer Disease (AD)

Interventions

DRUG

Daridorexant 50 mg

Study drug (Daridorexant 50 mg) taken orally each night 30 minutes before bedtime, for the 1 year duration of the study

DRUG

Placebo

Study drug (Placebo) will be taken orally each night, 30 minutes before bedtime, for the 1 year duration of the study

Sponsors & Collaborators

  • Weston Family Foundation

    collaborator OTHER

  • Douglas Mental Health University Institute

    lead OTHER

Principal Investigators

  • Sylvia Villeneuve, PhD · McGill University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • Canada

Study Locations

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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 NCT07213349 on ClinicalTrials.gov