Sleep impairment in people at risk for Alzheimer's disease
Objective Sleep Impairment in APOEε4/ε4 Subjects at Risk of Developing Alzheimer's Disease: Risk Factor for Cognitive Decline?
This study will test whether sleep problems are linked with early Alzheimer's changes and cognitive decline in people at higher risk of the disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier, Hérault) |
| Trial ID | NCT05649514 on ClinicalTrials.gov |
What this trial studies
The study enrolls adults with mild Alzheimer's disease (MMSE 21-30) or individuals at elevated genetic risk and collects objective and subjective sleep measures alongside cognitive testing and biomarker assays. Participants will undergo overnight polysomnography, continuous actimetry, sleep and behavior questionnaires, and neuropsychological assessments. Biomarker assays (including measures related to β-amyloid) will be compared with sleep metrics and cognitive performance to look for correlations. The approach aims to determine whether disturbed sleep tracks with early AD pathology and cognitive decline.
Who should consider this trial
Good fit: Adults with mild Alzheimer's disease (MMSE 21-30) or people at increased genetic risk (for example APOE ε4 carriers) who can complete sleep testing, questionnaires, and neuropsychological visits are appropriate candidates.
Not a fit: Patients with advanced dementia, major depression, inability to perform neuropsychological tests or sleep assessments, those living in nursing homes, or those legally protected/deprived of liberty are unlikely to benefit from participation.
Why it matters
Potential benefit: If a clear link is found, earlier detection and treatment of sleep problems could help slow cognitive decline or delay symptom progression.
How similar studies have performed: Prior observational studies have reported associations between disrupted sleep and amyloid accumulation, but causal relationships and clinical benefits from treating sleep to alter AD progression remain unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of mild Alzheimer's disease with a MMS between 21-30 * Without 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 * The 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 Exclusion Criteria: * 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 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) * Major protected by law; * Short-term life-threatening conditions
Where this trial is running
Montpellier, Hérault
- CHU de Montpellier — Montpellier, Hérault, France (Recruiting)
Study contacts
- Principal investigator: Karim BENNYS, MD — University Hospital, Montpellier
- Study coordinator: Yves Dauvilliers, MD
- Email: y-dauvilliers@chu-montpellier.fr
- Phone: +33467335219
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.