Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease
NCT ID: NCT05649514
Last Updated: 2025-06-27
Study Results
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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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-02-05
2027-12-01
Brief Summary
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Treatment protocols in the field of Alzheimer's disease (AD) are directed towards participants at risk of developing the disease, such as those who carry at least one ε4 allele on apolipoprotein E (APOE ε4). An individual with 2 ε4 copies has a 30-55% risk of developing AD with an age of onset around 68 years and a dose effect of the allele on risk and age of onset of symptoms.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Single arm
Prodromal Alzheimer's patients
Polysomnography
Polysomnography will be performed for 24 hours at inclusion and 24 months
Neuropsychological assessment
A full neuropsychological assessment will be performed at inclusion, 12 and 24 months
Questionnaires on sleep and behavioural problems
Questionnaires on sleep and behavioural problems
Actimetrics
Measurement of actimetrics for 14 days at inclusion and at 24 months
Biomarker assay
Determination of the biomarkers Aβ42, Aβ40, Tau and P-Tau in blood and in the cerebrospinal fluid
Interventions
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Polysomnography
Polysomnography will be performed for 24 hours at inclusion and 24 months
Neuropsychological assessment
A full neuropsychological assessment will be performed at inclusion, 12 and 24 months
Questionnaires on sleep and behavioural problems
Questionnaires on sleep and behavioural problems
Actimetrics
Measurement of actimetrics for 14 days at inclusion and at 24 months
Biomarker assay
Determination of the biomarkers Aβ42, Aβ40, Tau and P-Tau in blood and in the cerebrospinal fluid
Eligibility Criteria
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Inclusion Criteria
* Without anticholinesterase and/or memantine treatment or on stable doses for at least 3 months
* No antidepressant or anxiolytic treatment or stopped for at least 15 days
* The presence of a family carer to complete neuropsychological scales, questionnaires and sleep diaries
* Signed informed consent
* Able to carry out all visits and follow study procedures
* Affiliation to the French social security system
Exclusion Criteria
* Insufficient clinical and paraclinical information for the diagnosis of AD
* Patient living in a nursing home
* Illiteracy or inability to perform psycho-behavioural tests
* Major physical or neurosensory problems that may interfere with the tests
* Patient deprived of liberty, by judicial or administrative decision;
* Major depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
* Major protected by law;
* Short-term life-threatening conditions
50 Years
85 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Karim BENNYS, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
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CHU de Montpellier
Montpellier, Hérault, France
Countries
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Central Contacts
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Facility Contacts
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Yves DAUVILLIERS
Role: primary
Other Identifiers
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RECHMPL22_0392
Identifier Type: -
Identifier Source: org_study_id
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