RecruitingPhase 2NCT07213349

Daridorexant for Alzheimer Disease Prevention

Double Blind Clinical Trial of Daridorexant (Dual Orexin Receptor Antagonist) for Alzheimer Disease Prevention


Sponsor

Douglas Mental Health University Institute

Enrollment

240 participants

Start Date

Oct 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a sleep medication called daridorexant (which helps people stay asleep) can help prevent or delay the development of Alzheimer's disease in older adults who have sleep problems but do not yet have dementia. **You may be eligible if...** - You do not have dementia (scoring above the threshold on standard memory tests) - You have had at least 6 years of formal education - Any mental health medications you take have been stable for at least 1 month - You can provide consent in English or French **You may NOT be eligible if...** - You have already been diagnosed with dementia - You have an unstable psychiatric condition, active suicidal thoughts, or a diagnosis of narcolepsy - You have severe untreated sleep apnea or a sleep disorder called REM behavior disorder - You currently take this type of sleep medication (called a DORA), benzodiazepines, or z-drugs more than twice per week - You take certain medications that affect how drugs are broken down in the body (strong CYP3A4 inhibitors/inducers) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDaridorexant 50 mg

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

DRUGPlacebo

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


Locations(1)

Centre StoP-Alzheimer (Douglas Mental Health University Institute - Research Centre)

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07213349


Related Trials