Daridorexant for Alzheimer Disease Prevention

Sponsor
Douglas Mental Health University Institute
Study ID
NCT07213349
Phase
PHASE2
Status
Recruiting
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Conditions

  • Alzheimer Disease (AD)

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Daridorexant 50 mg — DRUG
    Study drug (Daridorexant 50 mg) taken orally each night 30 minutes before bedtime, for the 1 year duration of the study
  • Placebo — DRUG
    Study drug (Placebo) will be taken orally each night, 30 minutes before bedtime, for the 1 year duration of the study

Study Details

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.

Key Dates

Start date
Oct 14, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Daridorexant 50 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in plasma p-tau217/np-tau217 ratio [ Time Frame: baseline up to estimated 12 months ]

Central Contacts

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