Alzheimer Disease study: Daridorexant
Official title Daridorexant for Alzheimer Disease Prevention
ClinicalTrials.gov ID: NCT07213349
What this study is testing
What is Daridorexant 50 mg?
This is an investigational oral medication being studied to see if it can help prevent Alzheimer's disease. It is designed to block orexin receptors in the brain, a pathway that may help clear proteins linked to Alzheimer's.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether daridorexant, a sleep medication, can help keep the brain healthy and prevent Alzheimer disease.
- Who it's for
- You may be able to join if you do not have Alzheimer’s disease dementia.
- What's involved
- You would take daridorexant, a sleep pill, for a set time. You will have visits and simple tests to check your brain.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 90. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
- Currently taking a DORA
- Allergy or significant adverse reaction to DORA
See the full eligibility 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
- 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
- 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 study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 90 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.