Actively Recruiting
Daridorexant for Alzheimer Disease Prevention
Led by Douglas Mental Health University Institute · Updated on 2025-12-19
240
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
Sponsors
D
Douglas Mental Health University Institute
Lead Sponsor
W
Weston Family Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Daridorexant for Alzheimer Disease Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Without dementia as shown by MoCA >21 or MMSE >24 or Clinical Dementia Rating <1
- At least 6 years of formal education
- Stable psychoactive medication for at least 1 month before screening with no plans to change dose during treatment
- Able to provide written consent in English or French
You will not qualify if you...
- Clinical diagnosis of major neurocognitive disorder
- Unstable psychiatric condition including active suicidal ideation
- Unstable medical condition as judged by investigator
- History of drug or alcohol dependence or abuse within 1 year before screening
- Currently taking a dual orexin receptor antagonist (DORA)
- Allergy or serious reaction to DORA
- Use of benzodiazepines or z-drugs more than twice per week in the last month
- Use of major or moderate CYP3A4 inducers and inhibitors
- Use of strong central nervous system depressants, opioids, strong painkillers, antipsychotics, or sedative antidepressants
- Active use of cholinesterase inhibitors or memantine
- Pregnant or breastfeeding women
- Severe obstructive sleep apnea
- Untreated rapid eye movement (REM) sleep behavior disorder, restless leg syndrome, or parasomnia
- Diagnosis of narcolepsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Centre StoP-Alzheimer (Douglas Mental Health University Institute - Research Centre)
Montreal, Quebec, Canada, H4H 1R3
Actively Recruiting
Research Team
J
Jennifer Tremblay-Mercier, MSc
CONTACT
N
Nolan-Patrick Cunningham, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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