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

Not Applicable

Not yet recruiting

• Conditions: Neuropathology; Cognitive Decline; Sleep Disorder
• Interventions: Procedure: Polysomnography; Behavioral: Neuropsychological assessment; Behavioral: Questionnaires on sleep and behavioural problems; Procedure: Actimetrics; Other: Biomarker assay

• Registration Number: NCT05649514
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-09
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-27
• Last Update Posted: 2024-05-29
• Study Start: 2024-07-01
• Primary Completion: 2027-08-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Actimetrics	Prodromal Alzheimer's patients
Single arm	Questionnaires on sleep and behavioural problems	Prodromal Alzheimer's patients
Single arm	Polysomnography	Prodromal Alzheimer's patients
Single arm	Biomarker assay	Prodromal Alzheimer's patients
Single arm	Neuropsychological assessment	Prodromal Alzheimer's patients

Primary Outcome Measures

Name	Time	Method
Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score	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 Outcome Measures

Name	Time	Method
Time spent in Rapide Eye Movement (REM) sleep during polysomnography	At inclusion and at 24 months	Time spent in REM in hours and minutes during polysomnography
Concentration of proteins involved in Alzheimer disease	At inclusion and at 24 months	Determination of Aβ42, Aβ40, Tau and P-Tau proteins in serum and cerebrospinal fluid
Sleep time at stage 1-2 during polysomnography	At inclusion and at 24 months	Time spent in stage 1-2 sleep measured in hours and minutes during polysomnography
Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score	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
Cognitive decline in ADCS-PACC composite score	At inclusion and at 12 months	The ADCS-PACC composite score is used to assess cognitive decline
Sleep time at stage 3 during polysomnography	At inclusion and at 24 months	Time spent in stage 3 sleep measured in hours and minutes during polysomnography
Apnea Hypopnea index	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
Noctural oxygene saturation (SaO2)	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