Recruiting
Phase 2

Daridorexant

Sponsor:

Douglas Mental Health University Institute

Code:

NCT07213349

Conditions

Alzheimer Disease (AD)

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Daridorexant 50 mg

Placebo

Study Details

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. 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

Alzheimer Disease (AD)

Study ID

NCT07213349

Start date

Oct 14, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Daridorexant 50 mg

placebo comparator: Placebo

Interventions

Daridorexant 50 mg

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

Placebo

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

Primary outcome measure

  • Change in plasma p-tau217/np-tau217 ratio [ Time Frame: baseline up to estimated 12 months ]

Central Contacts and Locations

Central contacts

Jennifer Tremblay-Mercier, MSc

855-888-4485prevenir.alzheimer@douglas.mcgill.ca

Nolan-Patrick Cunningham, BA

15147616131nolan-patrick.cunningham.comtl@ssss.gouv.qc.ca

Locations

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

Recruiting

Montreal, Quebec, Canada, H4H 1R3

Principal Investigator:

Sylvia Villeneuve, PhD

More Information

Sponsor

Douglas Mental Health University Institute

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Keywords

  • Prevention
  • Sleep
  • Amyloid
  • Tau
  • Cognitive decline
  • Dual Orexin Receptor Antagonist (DORA)
  • Daridorexant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Douglas Mental Health University Institute on 2025-12-19.