Daridorexant for Alzheimer Disease Prevention
ConditionAlzheimer Disease (AD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-90
SponsorDouglas Mental Health University Institute
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Clinical diagnosis of major neurocognitive disorder
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
Trial design
Treatments tested in this trial
- Daridorexant 50 mg
- Placebo
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Douglas Mental Health University Institute
Lead sponsor
Weston Family Foundation
Collaborator
Source ClinicalTrials.gov