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
- Diseases
- Alzheimer disease
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre StoP-Alzheimer (Douglas Mental Health University Institute - Research Centre) Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.