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Clinical Trials in France / NCT05629871
Recruiting Not applicable

Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?

NCT05629871 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Montpellier
Phase
Not applicable
Started
2023-04-17
Last updated
2025-10-07

Condition(s) studied

Neuropathology

Investigational drug(s) / intervention(s)

PolysomnographyNeuropsychological assessmentQuestionnaires on sleep and behavioural problemsActimetryFractional diuresisInternal temperature measurementBiomarker assay

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

Study summary

Alzheimer's disease (AD) is characterised by a progressive loss of memory and cognitive function. In the early stages of AD, there is a progressive accumulation of molecules: β-amyloid peptides (Aβ) in the brain. There is a link between the accumulation of Aβ peptides and the deterioration of sleep, but current knowledge does not confirmed this link. The objective of this study is to define whether there is a link between cognitive decline and sleep disorders. If a correlation is found, this could allow earlier treatment of sleep disorders in the longer term in order to slow the development of AD.

Eligibility

Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of mild Alzheimer's disease with a Mini Mental State (MMS) between 21-30 * 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: * Genetic form of alzheimer's disease * 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.

Primary outcome measure(s)

  • Change in the Free and Cued Selective Reminding Test (FCSRT) scale score — From inclusion to 24 months
    The FCSRT test evaluates memory, the score obtained is between 0 and 48, higher score mean a better outcome

Trial sites (3)

FacilityCityRegionStatus
University Hospital, Montpellier Montpellier France Recruiting
University Hospital of Poitiers Poitiers France Not Yet Recruiting
University Hospital of Toulouse Toulouse France Not Yet Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05629871 on ClinicalTrials.gov ↗ ← All trials in France