RecruitingNot ApplicableNCT05649514

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?


Sponsor

University Hospital, Montpellier

Enrollment

50 participants

Start Date

Feb 5, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study looks at sleep problems in people with mild Alzheimer's disease and how sleep disturbances might be connected to the disease's progression. It also involves a family caregiver in the monitoring process. **You may be eligible if...** - You have a diagnosis of mild Alzheimer's disease with a cognitive score between 21 and 30 - You are either not on Alzheimer's medications or have been on stable doses for at least 3 months - A family member or caregiver is available to assist with the study **You may NOT be eligible if...** - You are currently taking antidepressants or anxiety medications (unless stopped for at least 15 days) - You have severe cognitive impairment - You do not have a family caregiver available Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPolysomnography

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

BEHAVIORALNeuropsychological assessment

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

BEHAVIORALQuestionnaires on sleep and behavioural problems

Questionnaires on sleep and behavioural problems

PROCEDUREActimetrics

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

OTHERBiomarker assay

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


Locations(1)

CHU de Montpellier

Montpellier, Hérault, France

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NCT05649514


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