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PAD-DORA

RecruitingPhase 2

Daridorexant for Alzheimer Disease Prevention

Double Blind Clinical Trial of Daridorexant (Dual Orexin Receptor Antagonist) for Alzheimer Disease Prevention

Lead sponsor

Douglas Mental Health University Institute

Asset

Daridorexant

Listed sites

Recruiting sites

Enrollment

240

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•MMSE ≥24•MoCA ≥21

Primary endpoint

•Phosphorylated tau 217 (p-tau217)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Other grantBH-10983Weston Family Foundation

Org study IDDARAD2025

NCT IDNCT07213349

Timeline

Milestones

Study first posted2025-10-08actual

Study start2025-10-14actual

Last update posted2025-12-19actual

Primary completion2028-12estimated (month precision)

Study completion2029-12estimated (month precision)

Assets

Drug assets

Daridorexant

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Global cognition

Amyloid biomarkers

Behavior / neuropsychiatric

Neurodegeneration biomarkers

Global cognition

2 endpoints

Secondary/protocol endpoint

Change from baseline on Preclinical Alzheimer Cognitive Composite (PACC) score

Time frame:baseline up to estimated 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline on XpressO MoCA

Time frame:baseline up to estimated 12 months

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Other/protocol endpoint

Change in sleep efficiency

Time frame:baseline up to estimated 12 months

change from baseline, improvement

Amyloid biomarkers

2 endpoints

Secondary/protocol endpoint

Change in plasma Aβ42/Aβ40 ratio

Time frame:baseline up to estimated 12 months

change from baseline, improvement

Other/protocol endpoint

Change in CSF Aβ42/Aβ42

Time frame:baseline up to estimated 12 months

change from baseline, improvement

Neurodegeneration biomarkers

1 endpoint

Other/protocol endpoint

Change in plasma GFAP

Time frame:baseline up to estimated 12 months

change from baseline, improvement

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

Change in plasma p-tau217/np-tau217 ratio

Time frame:baseline up to estimated 12 months

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in plasma p-tau181/np-tau181 ratio

Time frame:baseline up to estimated 12 months

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in p-tau181/np-tau181 after 3-months

Time frame:baseline to estimated 3 months

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in p-tau217/np-tau217 after 3 months

Time frame:baseline up to estimated 3 months

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.