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Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease (WAVE-APOE4)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Not yet enrolling

Conditions

Neuropathology
Sleep Disorder
Cognitive Decline

Treatments

Behavioral: Questionnaires on sleep and behavioural problems
Behavioral: Neuropsychological assessment
Other: Biomarker assay
Procedure: Actimetrics
Procedure: Polysomnography

Study type

Interventional

Funder types

Other

Identifiers

NCT05649514
RECHMPL22_0392

Details and patient eligibility

About

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.

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.

Enrollment

50 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of mild Alzheimer's disease with a MMS between 21-30
  • 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

  • Genetic form of alzheimer's disease
  • 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Single arm
Experimental group
Description:
Prodromal Alzheimer's patients
Treatment:
Procedure: Polysomnography
Procedure: Actimetrics
Other: Biomarker assay
Behavioral: Neuropsychological assessment
Behavioral: Questionnaires on sleep and behavioural problems

Trial contacts and locations

0

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Central trial contact

Yves Dauvilliers, MD

Data sourced from clinicaltrials.gov

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