Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?
NCT ID: NCT05629871
Last Updated: 2025-10-07
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
132 participants
INTERVENTIONAL
2023-04-17
2027-07-01
Brief Summary
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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
Alzheimer
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
Actimetry
Measurement of actimetrics for 14 days at inclusion and at 24 months
Fractional diuresis
Split diuresis from 7pm-7am, 7am-12am and 12pm-19pm during polysomnography at inclusion inclusion and 24 months to measure melatonin concentration
Internal temperature measurement
eCelsius capsule to measure internal temperature at inclusion and 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
Actimetry
Measurement of actimetrics for 14 days at inclusion and at 24 months
Fractional diuresis
Split diuresis from 7pm-7am, 7am-12am and 12pm-19pm during polysomnography at inclusion inclusion and 24 months to measure melatonin concentration
Internal temperature measurement
eCelsius capsule to measure internal temperature at inclusion and 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
* The presence of a family carer to complete neuropsychological scales, questionnaires and sleep diaries
* Having a neurological assessment and/or follow-up requiring blood and cerebrospinal fluid (CSF) sampling with biomarkers for diagnostic purposes
* Patient who had a lumbar puncture less than one year ago or patient with a scheduled lumbar puncture as part of care
* 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
* Anticholinesterase and/or memantine treatment or on stable doses for at least 3 months
* Use of antidepressants, anxiolytics, hypnotics, neuroleptics, 15 days before inclusion
* 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
* Initial contraindication to diagnostic lumbar puncture (LP) (spinal surgery, skin infection, haemostasis abnormality, intracranial hypertension, severe coagulation disorders, curative anticoagulant therapy, severe liver failure)
* Refusal to perform a diagnostic lumbar puncture
* Contraindication to the use of E-Celsius: people weighing less than 40 kg, with intestinal disorders, with known swallowing disorders
* Patient deprived of liberty, by judicial or administrative decision;
* Major protected by law;
* Patient in a period of relative exclusion from another protocol or for whom the maximum annual compensation of €4500 has been reached;
* Refusal to participate in the protocol.
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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University Hospital, Montpellier
Montpellier, , France
University Hospital of Poitiers
Poitiers, , France
University Hospital of Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Karim BENNYS, MD
Role: primary
Marc PACCALIN, MD
Role: primary
Rachel DEBS, MD
Role: primary
Other Identifiers
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RECHMPL18_0061
Identifier Type: -
Identifier Source: org_study_id
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