Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Daridorexant 50 mg

    Drug

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

  • Placebo

    Drug

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

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Daridorexant 50 mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in plasma p-tau217/np-tau217 ratio

Biological progression as measured by p-tau217/np-tau217 ratio in plasma

Time frame
baseline up to estimated 12 months

Secondary outcomes

1

Change in plasma p-tau181/np-tau181 ratio

Biological progression as measured by p-tau181/np-tau181 ratio in plasma

Time frame
baseline up to estimated 12 months
2

Change in plasma Aβ42/Aβ40 ratio

Biological progression as measured by Aβ42/Aβ40 ratio in plasma

Time frame
baseline up to estimated 12 months
3

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

Cognitive progression as measured with a modified version of the Preclinical Alzheimer Cognitive Composite (PACC) score. The PACC score is created by averaging the z-scores of several neuropsychological tests to track subtle changes, where a higher PACC z-score indicates better cognition.

Time frame
baseline up to estimated 12 months
4

Change from baseline on XpressO MoCA

Cognitive progression as measured with the self-administered digital XpressO MoCA medical screening tool. The maximum possible score is 100 points, with higher values suggesting better cognition.

Time frame
baseline up to estimated 12 months

Other outcomes

1

Change in CSF Aβ42/Aβ42

Change in Aβ42/Aβ40 ratio in cerebrospinal fluid in a subset of participants

Time frame
baseline up to estimated 12 months
2

Change in sleep efficiency

Change in sleep efficiency as measured by EEG recordings

Time frame
baseline up to estimated 12 months
3

Change in plasma GFAP

Change in astroglial activation and astrocytosis as measured by glial fibrillary acidic protein (GFAP) levels in plasma.

Time frame
baseline up to estimated 12 months
4

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

Biological progression as measured by p-tau181/np-tau181 ratio at 3 months, in plasma.

Time frame
baseline to estimated 3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Douglas Mental Health University Institute

Lead sponsor

Weston Family Foundation

Collaborator

Source ClinicalTrials.gov
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