Testing Daridorexant to Help Prevent Alzheimer Disease
Tests daridorexant against placebo in adults without Alzheimer dementia, to study brain protein clearance.
Plain-language title generated from the registry record
Registry title: Daridorexant for Alzheimer Disease Prevention
Key facts
- Where
- Montreal, CanadaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 50 to 90 who do not have dementia. It tests daridorexant, a sleep medicine, for Alzheimer's disease prevention. People with or without sleep problems can join.
- Age
- 50 Years to 90 Years
- Sex
- All sexes can join.
- Disease stage
- No dementia: MoCA >21 or MMSE > 24 or Clinical Dementia Rating <1.
- Earlier treatment
- Psychoactive medication must have been stable for 1 month before screening, with no planned dose change during treatment. People currently taking a DORA cannot join.
Main reasons for not taking part
- Clinical diagnosis of major neurocognitive disorder
- Pregnant or breast feeding women
- Severe obstructive sleep apnea (OSA) or narcolepsy
- Active use of cholinesterase inhibitors or memantine
- Allergy or significant adverse reaction to DORA
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 90 years old?
Source: NCT07213349, who can take part
Where in Canada
- Centre StoP-Alzheimer (Douglas Mental Health University Institute - Research Centre)Montreal, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Douglas Mental Health University Institute
- Trial code
- NCT07213349
- Record updated
- 19 December 2025
- Original description
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.Read full original descriptionShow less
Double Blind Clinical Trial of Daridorexant (Dual Orexin Receptor Antagonist) for Alzheimer Disease Prevention
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.
Inclusion: 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: 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; 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; 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.