Sleep impairment in people at risk for Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.