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NCT Number: NCT05649514

Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease

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.

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Key information

Conditions

Neuropathology Cognition Disorders Cognitive Decline Cognitive Dysfunction Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Wake Disorders

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Montpellier

Montpellier, Hérault, 34000, France

Location status: Recruiting

Location contact

Yves DAUVILLIERS

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography

Procedure

Polysomnography will be performed for 24 hours at inclusion and 24 months

Neuropsychological Assessment

Behavioral

A full neuropsychological assessment will be performed at inclusion, 12 and 24 months

Questionnaires on sleep and behavioural problems

Behavioral

Questionnaires on sleep and behavioural problems

Actimetrics

Procedure

Measurement of actimetrics for 14 days at inclusion and at 24 months

Biomarker assay

Other

Determination of the biomarkers Aβ42, Aβ40, Tau and P-Tau in blood and in the cerebrospinal fluid

Primary outcomes

  1. Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score

    Time frame: From inclusion to 24 months

    The ADCS-PACC scale will be based on scores from the Mini Mental State Examination (MMSE), the Free Recall/Indicated Recall Test, the Digit Substitution Symbol Test, the Wechsler Intelligence Scale for Adults (WAIS-IV), and the 2-minute Verbal Fluency Test

Secondary outcomes

  1. Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score

    Time frame: From inclusion to 12 months

    The ADCS-PACC scale will be based on scores from the Mini Mental State Examination (MMSE), the Free Recall/Indicated Recall Test, the Digit Substitution Symbol Test, the Wechsler Intelligence Scale for Adults (WAIS-IV), and the 2-minute Verbal Fluency Test

  2. Cognitive decline in ADCS-PACC composite score

    Time frame: At inclusion and at 12 months

    The ADCS-PACC composite score is used to assess cognitive decline

  3. Concentration of proteins involved in Alzheimer disease

    Time frame: At inclusion and at 24 months

    Determination of Aβ42, Aβ40, Tau and P-Tau proteins in serum and cerebrospinal fluid

  4. Sleep time at stage 1-2 during polysomnography

    Time frame: At inclusion and at 24 months

    Time spent in stage 1-2 sleep measured in hours and minutes during polysomnography

  5. Sleep time at stage 3 during polysomnography

    Time frame: At inclusion and at 24 months

    Time spent in stage 3 sleep measured in hours and minutes during polysomnography

  6. Time spent in Rapide Eye Movement (REM) sleep during polysomnography

    Time frame: At inclusion and at 24 months

    Time spent in REM in hours and minutes during polysomnography

  7. Apnea Hypopnea index

    Time frame: At inclusion and at 24 months

    The Apnea-Hypopnea Index is calculated from the number of apneas and hypopneas per hour of sleep (AHI = number of apneas + number of hyopneas / number of hours of sleep) during polysomnography

  8. Noctural oxygene saturation (SaO2)

    Time frame: At inclusion and at 24 months

    The noctural SaO2 is an average of SaO2 values taken during the night. The value is expressed as a percentage and is measured during polysomnography

Study contacts

Contact information is provided by the study sponsor or research team.

Yves Dauvilliers, MD

CONTACT

[email protected]

+33467335219

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Objective Sleep Impairment in APOEε4/ε4 Subjects at Risk of Developing Alzheimer's Disease: Risk Factor for Cognitive Decline?

Acronym: WAVE-APOE4

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 14, 2022
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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