NCT07213349 · Phase 2 · RECRUITING
Daridorexant for Alzheimer Disease Prevention
This trial tests whether daridorexant, an existing sleep medication, helps the brain clear proteins linked to Alzheimer's, compared with a placebo. It enrolls people without dementia, whether or not they have sleep problems. It is a Phase 2 trial, meaning researchers are testing whether it works and is safe, not yet proven or approved for this purpose.
Eligibility criteria
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-12-19