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

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.

Conditions

• Neuropathology
• Cognitive Decline
• Sleep Disorder

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

Sponsors & Collaborators

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

  collaborator OTHER_GOV

• University Hospital, Montpellier

  lead OTHER

Principal Investigators

• Karim BENNYS, MD · University Hospital, Montpellier

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-05

Primary Completion

2027-08-01

Completion

2027-12-01

Countries

• France

Study Locations