Actively Recruiting
Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease
Led by University Hospital, Montpellier · Updated on 2025-06-27
50
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Montpellier
Lead Sponsor
I
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of mild Alzheimer's disease with a MMS between 21-30
- No 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
- 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
- Affiliated to the French social security system
You will not qualify if you...
- Genetic form of Alzheimer's disease
- Insufficient clinical and paraclinical information for diagnosis of AD
- Living in a nursing home
- Illiteracy or inability to perform psycho-behavioural tests
- Major physical or neurosensory problems that may interfere with tests
- Patient deprived of liberty by judicial or administrative decision
- Major depression according to DSM-5
- Major protected by law
- Short-term life-threatening conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU de Montpellier
Montpellier, Hérault, France, 34000
Actively Recruiting
Research Team
Y
Yves Dauvilliers, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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