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Daridorexant for Alzheimer Disease Prevention

NCT ID: NCT07213349

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-14

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Alzheimer's disease (AD) begins decades before symptoms with the accumulation of amyloid plaques and tau tangles, and interventions that slow or prevent this process could greatly reduce its impact. Dual orexin receptor antagonists (DORAs), drugs developed for insomnia, may help clear amyloid and tau, reduce neuroinflammation, and improve cognition through mechanisms that could be both related and unrelated to sleep quality. Early animal and human studies suggest that DORAs can alter biomarkers of Alzheimer's pathology making the orexin pathway modulation a promising strategy for Alzheimer's prevention. Daridorexant, one of the two DORAs available in Canada, stands out as a well-tolerated candidate for prevention due to its safety profile.

We want to evaluate the potential of Daridorexant for prevention of AD in this single-site, double-blind, randomized (1:1), placebo-controlled trial evaluating 50 mg of daridorexant versus placebo over 12 months in 240 participants. The primary biological outcome is the change from baseline to 12 months in the plasma ratio of phosphorylated tau181 to unphosphorylated tau181 (p-tau181/np-tau181). Secondary outcomes include changes in additional plasma biomarkers, cognitive performance, sleep parameters, and safety measures.

Conditions

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Alzheimer Disease (AD)

Keywords

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Prevention Sleep Amyloid Tau Cognitive decline Dual Orexin Receptor Antagonist (DORA) Daridorexant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a single site, double blinded, randomized, placebo-controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Research Staff (Research Assistants, Nurse, Coordinators)

Study Groups

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Daridorexant 50 mg

Group Type EXPERIMENTAL

Daridorexant 50 mg

Intervention Type DRUG

Study drug (Daridorexant 50 mg) taken orally each night 30 minutes before bedtime, for the 1 year duration of the study

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Study drug (Placebo) will be taken orally each night, 30 minutes before bedtime, for the 1 year duration of the study

Interventions

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Daridorexant 50 mg

Study drug (Daridorexant 50 mg) taken orally each night 30 minutes before bedtime, for the 1 year duration of the study

Intervention Type DRUG

Placebo

Study drug (Placebo) will be taken orally each night, 30 minutes before bedtime, for the 1 year duration of the study

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Weston Family Foundation

OTHER

Sponsor Role collaborator

Douglas Mental Health University Institute

OTHER

Sponsor Role lead

Responsible Party

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Sylvia Villeneuve

Director of the StoP-AD Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sylvia Villeneuve, PhD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

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Centre StoP-Alzheimer (Douglas Mental Health University Institute - Research Centre)

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jennifer Tremblay-Mercier, MSc

Role: CONTACT

Phone: 855-888-4485

Email: [email protected]

Nolan-Patrick Cunningham, BA

Role: CONTACT

Phone: 15147616131

Email: [email protected]

Other Identifiers

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BH-10983

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DARAD2025

Identifier Type: -

Identifier Source: org_study_id