Daridorexant for Alzheimer's disease prevention

Eligibility criteria

Inclusion Criteria:
1. Without dementia as determined by: MoCA >21 or MMSE > 24 or Clinical Dementia Rating <1
2. Minimum of 6 years of formal education
3. Stable psychoactive medication for 1 month prior to screening with no intention to change dose during treatment period
4. Capacity to provide written consent in English or French
Exclusion Criteria:
1. Clinical diagnosis of major neurocognitive disorder
2. Unstable psychiatric condition
3. Clinically significant active suicidal ideations
4. Unstable medical condition in the opinion of the investigator.
5. Known or suspected history of drug or alcohol dependence or abuse within one year of the screening visit
6. Currently taking a DORA
7. Allergy or significant adverse reaction to DORA
8. Use of benzodiazepines or z-drugs > 2 times per week in the last month.
9. Use of major and moderate CYP3A4 inducers and inhibitors
10. Use of strong central nervous system depressants, opioids, strong analgesics, antipsychotics, sedative antidepressants.
11. Active use of cholinesterase inhibitors or memantine
12. Women who are breast feeding or pregnant
13. Severe obstructive sleep apnea (OSA)
14.Clinically significant non-treated rapid eye movement (REM) sleep behavior disorder, restless leg syndrome or parasomnia;
15. 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 2025-10-07