Fact CheckerSign in

NCT07213349RecruitingPhase 2

Daridorexant for Alzheimer Disease Prevention

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

Source: ClinicalTrials.gov · Last updated 19 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
240 (estimated)
First submitted
24 Sept 2025
Start date
14 Oct 2025
Primary completion date
Dec 2028
Lead sponsor
Douglas Mental Health University Institute
NCT number
NCT07213349

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 240
  • From 14 Oct 2025 to the primary completion date, Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently taking a DORA
  • Use of benzodiazepines or z-drugs \> 2 times per week in the last month.
  • Use of major and moderate CYP3A4 inducers and inhibitors
  • Active use of cholinesterase inhibitors or memantine

Other illness

  • Clinical diagnosis of major neurocognitive disorder
  • Unstable psychiatric condition:
  • 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
  • Allergy or significant adverse reaction to DORA
  • Clinically significant non-treated rapid eye movement (REM) sleep behavior disorder, restless leg syndrome or parasomnia;

Other

  • Clinically significant active suicidal ideations
  • Use of strong central nervous system depressants, opioids, strong analgesics, antipsychotics, sedative antidepressants.
  • Women who are breast feeding or pregnant
  • Severe obstructive sleep apnea (OSA)\*
  • Diagnosis of narcolepsy

Who the study is looking for

  • 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

Age in the registry: 50 years to 90 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre StoP-Alzheimer (Douglas Mental Health University Institute - Research Centre)
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.