Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 90
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
240 (estimated)
Sponsor
Douglas Mental Health University Institute · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 wr…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.