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Recruiting NCT05649514

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

No phase Interventional Neuropathology Cognitive Decline Sleep Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Polysomnography, Neuropsychological assessment, Questionnaires on sleep and behavioural problems, Actimetrics.
Who it may be relevant to
Registry conditions: Neuropathology, Cognitive Decline, Sleep Disorder. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure Polysomnography
    Polysomnography will be performed for 24 hours at inclusion and 24 months
  • Behavioral Neuropsychological assessment
    A full neuropsychological assessment will be performed at inclusion, 12 and 24 months
  • Behavioral Questionnaires on sleep and behavioural problems
    Questionnaires on sleep and behavioural problems
  • Procedure Actimetrics
    Measurement of actimetrics for 14 days at inclusion and at 24 months
  • Other Biomarker assay
    Determination of the biomarkers Aβ42, Aβ40, Tau and P-Tau in blood and in the cerebrospinal fluid

Primary outcome measures

  • Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score [Time frame: From inclusion to 24 months]
Secondary outcome measures (8)
  • Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score [Time frame: From inclusion to 12 months]
  • Cognitive decline in ADCS-PACC composite score [Time frame: At inclusion and at 12 months]
  • Concentration of proteins involved in Alzheimer disease [Time frame: At inclusion and at 24 months]
  • Sleep time at stage 1-2 during polysomnography [Time frame: At inclusion and at 24 months]
  • Sleep time at stage 3 during polysomnography [Time frame: At inclusion and at 24 months]
  • Time spent in Rapide Eye Movement (REM) sleep during polysomnography [Time frame: At inclusion and at 24 months]
  • Apnea Hypopnea index [Time frame: At inclusion and at 24 months]
  • Noctural oxygene saturation (SaO2) [Time frame: At inclusion and at 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • CHU de Montpellier — Montpellier

Identifiers

NCT: NCT05649514 · RECHMPL22_0392

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗