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

University Hospital, Montpellier50 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Neuropathology Cognitive Decline Sleep Disorder

Interventions

PolysomnographyPROCEDURE

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

Neuropsychological assessmentBEHAVIORAL

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

Questionnaires on sleep and behavioural problemsBEHAVIORAL

Questionnaires on sleep and behavioural problems

ActimetricsPROCEDURE

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

Biomarker assayOTHER

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Time frame: From inclusion to 24 months

Secondary Outcomes

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

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

Time frame: At inclusion and at 12 months

Concentration of proteins involved in Alzheimer disease

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