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

Last updated: May 24, 2024
Sponsor: University Hospital, Montpellier
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Loss

Dementia

Memory Problems

Treatment

Actimetry

Questionnaires on sleep and behavioural problems

Biomarker assay

Clinical Study ID

NCT05629871
RECHMPL18_0061
  • Ages 50-85
  • All Genders

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 Criteria

Inclusion

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, questionnairesand sleep diaries

  • Having a neurological assessment and/or follow-up requiring blood and cerebrospinalfluid (CSF) sampling with biomarkers for diagnostic purposes

  • Patient who had a lumbar puncture less than one year ago or patient with a scheduledlumbar 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

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 3months

  • Use of antidepressants, anxiolytics, hypnotics, neuroleptics, 15 days beforeinclusion

  • 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, skininfection, haemostasis abnormality, intracranial hypertension, severe coagulationdisorders, 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, withintestinal 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 themaximum annual compensation of €4500 has been reached;

  • Refusal to participate in the protocol.

Study Design

Total Participants: 132
Treatment Group(s): 7
Primary Treatment: Actimetry
Phase:
Study Start date:
April 17, 2023
Estimated Completion Date:
July 01, 2027

Connect with a study center

  • University Hospital, Montpellier

    Montpellier,
    France

    Active - Recruiting

  • University Hospital of Poitiers

    Poitiers,
    France

    Site Not Available

  • University Hospital of Toulouse

    Toulouse,
    France

    Site Not Available

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