NCT05649514 · RECRUITING

Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease

This study is observing whether poor sleep is linked to cognitive decline in people at early risk of Alzheimer's. Participants undergo sleep studies, cognitive testing, and biomarker checks — no experimental drug is involved. It is a non-interventional, observational study, meaning researchers are watching and measuring, not treating. The goal is to understand whether sleep problems predict or accelerate cognitive decline, which could eventually point toward earlier intervention.

You may qualify if

  • 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

You're excluded if

  • 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

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-06-27

View full record on ClinicalTrials.gov

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