Daridorexant for preventing Alzheimer disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-site, double-blind, randomized (1:1), placebo-controlled Phase 2 trial will enroll 240 participants and compare daridorexant 50 mg nightly to placebo for 12 months. The primary biological outcome is the change from baseline to 12 months in the plasma p-tau181/np-tau181 ratio; secondary outcomes include other plasma biomarkers, cognitive tests, sleep measures, and safety. The trial is testing a dual orexin receptor antagonist (DORA) because preclinical and early human work suggests DORAs may promote clearance of amyloid and tau, reduce neuroinflammation, and influence cognition through sleep-related and independent mechanisms. Daridorexant is chosen for its favorable tolerability profile among available DORAs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

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

Study contacts

• Principal investigator: Sylvia Villeneuve, PhD — McGill University
• Study coordinator: Jennifer Tremblay-Mercier, MSc
• Email: prevenir.alzheimer@douglas.mcgill.ca
• Phone: 855-888-4485

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.