NCT05649514

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-02-05
• Primary completion: 2027-08-01
• Completion: 2027-12-01
• First posted: 2022-12-14
• Last updated: 2025-06-27

Locations

1 site across 1 country: France