Status:
RECRUITING
Daridorexant for Alzheimer Disease Prevention
Lead Sponsor:
Douglas Mental Health University Institute
Collaborating Sponsors:
Weston Family Foundation
Conditions:
Alzheimer Disease (AD)
Eligibility:
All Genders
50-90 years
Phase:
PHASE2
Brief 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...
Detailed Description
Alzheimer's disease (AD) begins decades before symptoms with the accumulation of amyloid plaques and tau tangles, and interventions that slow or prevent this process could greatly reduce its impact. D...
Eligibility Criteria
Inclusion
- Without dementia as determined by: MoCA \>21 or MMSE \> 24 or Clinical Dementia Rating \<1
- Minimum of 6 years of formal education
- Stable psychoactive medication for 1 month prior to screening with no intention to change dose during treatment period
- Capacity to provide written consent in English or French
Exclusion
- Clinical diagnosis of major neurocognitive disorder
- Unstable psychiatric condition:
- Clinically significant active suicidal ideations
- Unstable medical condition in the opinion of the investigator.
- Known or suspected history of drug or alcohol dependence or abuse within one year of the screening visit
- Currently taking a DORA
- Allergy or significant adverse reaction to DORA
- Use of benzodiazepines or z-drugs \> 2 times per week in the last month.
- Use of major and moderate CYP3A4 inducers and inhibitors
- Use of strong central nervous system depressants, opioids, strong analgesics, antipsychotics, sedative antidepressants.
- Active use of cholinesterase inhibitors or memantine
- Women who are breast feeding or pregnant
- Severe obstructive sleep apnea (OSA)\*
- Clinically significant non-treated rapid eye movement (REM) sleep behavior disorder, restless leg syndrome or parasomnia;
- Diagnosis of narcolepsy
Key Trial Info
Start Date :
October 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT07213349
Start Date
October 14 2025
End Date
December 1 2029
Last Update
December 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre StoP-Alzheimer (Douglas Mental Health University Institute - Research Centre)
Montreal, Quebec, Canada, H4H 1R3