Actively Recruiting
Objective Sleep Impairment in APOEb54/b54 Subjects at Risk of Developing Alzheimer's Disease: Risk Factor for Cognitive Decline?
Led by University Hospital, Montpellier · Updated on 2025-06-27
50
Participants Needed
1
Research Sites
17 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) involves a gradual loss of memory and thinking skills, linked to the buildup of beta-amyloid peptides in the brain. Researchers are investigating whether sleep problems are connected to cognitive decline in people at risk of AD, especially those carrying two copies of the APOE ε4 gene, which increases the chance of developing AD with symptoms typically starting around age 68. Understanding this link could help treat sleep issues early to potentially slow AD progression. Participants diagnosed with mild Alzheimer's disease will undergo various assessments over two years. Sleep patterns will be studied using polysomnography for 24 hours at the start and after 24 months, alongside 14-day actimetrics measurements. Neuropsychological evaluations and sleep-related questionnaires will be completed at inclusion, 12 months, and 24 months. Blood and cerebrospinal fluid samples will be taken to analyze Alzheimer-related biomarkers like Aβ42, Aβ40, Tau, and P-Tau. During the study, participants will have regular visits for cognitive testing and sleep monitoring. Researchers will track changes in cognitive function using the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale from inclusion through 24 months. Sleep stages and breathing during sleep will be measured by polysomnography. The study includes safety and cognitive assessments, requiring participants to have a family caregiver to assist with questionnaires and diaries, and last for up to 24 months.
CONDITIONS
Brief 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
- Affiliation to the French social security system
You will not qualify if you...
- 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 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day at inclusion
Participants undergo polysomnography, neuropsychological assessments, actimetrics measurement, biomarker assays, and questionnaires on sleep and behavioral problems at inclusion to assess sleep impairment and cognitive status.
1 baseline visit (in-person) with tests and assessments
Duration - 24 months
Participants are monitored over 24 months with follow-up polysomnography, neuropsychological assessments, actimetrics measurement, and biomarker assays to track changes in cognitive and sleep parameters.
Follow-up visits at 12 months and 24 months for assessments
Trial Site Locations
Total: 1 location
1
CHU de Montpellier
Montpellier, Hérault, France, 34000
Actively Recruiting
Research Team
Y
Yves Dauvilliers, MD
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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