Daridorexant for Alzheimer Disease Prevention

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Alzheimer Disease (AD)

In brief

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 facts

Study ID

NCT07213349

Run by

Douglas Mental Health University Institute

People needed

240

Starts

2025-10-14

Expected to finish

2029-12-01

Last updated by the study team

2025-12-19

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Centre StoP-Alzheimer (Douglas Mental Health University Institute - Research Centre) — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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