Exploring the link between sleep patterns and cognitive decline in early Alzheimer's disease
Official title: Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?
Run by University Hospital, Montpellier · NCT05629871 · Data updated 2026-11-12
This study is trying to see if sleep problems in people with mild Alzheimer's disease are linked to brain changes and if fixing those sleep issues could help slow down memory loss.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years to 85 Years |
| Sex | All |
| Enrollment | 132 (estimated) |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 3 sites (Montpellier and 2 other locations) |
| Status | Recruiting |
| Started | April 17, 2023 |
| Main results expected | July 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | October 7, 2025 |
| Trial ID | NCT05629871 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with mild Alzheimer's disease who have a Mini Mental State score between 21-30 and have a family carer to assist with assessments.
✕Probably not a fit
Patients with genetic forms of Alzheimer's disease or those currently on specific medications that affect cognitive function may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the relationship between sleep disorders and cognitive decline in individuals diagnosed with mild Alzheimer's disease. It aims to determine if there is a correlation between the accumulation of β-amyloid peptides in the brain and sleep disturbances. Participants will undergo polysomnography, neuropsychological assessments, and complete questionnaires regarding their sleep and behavioral issues. The findings could lead to earlier interventions for sleep disorders, potentially slowing the progression of Alzheimer's disease.
Why it matters
Potential benefit: If successful, this study could enable earlier treatment of sleep disorders, potentially slowing cognitive decline in Alzheimer's patients.
How similar studies have gone: While the link between sleep and cognitive decline is being explored, this specific approach is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of mild Alzheimer's disease with a Mini Mental State (MMS) between 21-30 * The presence of a family carer to complete neuropsychological scales, questionnaires and sleep diaries * Having a neurological assessment and/or follow-up requiring blood and cerebrospinal fluid (CSF) sampling with biomarkers for diagnostic purposes * Patient who had a lumbar puncture less than one year ago or patient with a scheduled lumbar puncture as part of care * 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 * Anticholinesterase and/or memantine treatment or on stable doses for at least 3 months * Use of antidepressants, anxiolytics, hypnotics, neuroleptics, 15 days before inclusion * 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 * Initial contraindication to diagnostic lumbar puncture (LP) (spinal surgery, skin infection, haemostasis abnormality, intracranial hypertension, severe coagulation disorders, curative anticoagulant therapy, severe liver failure) * Refusal to perform a diagnostic lumbar puncture * Contraindication to the use of E-Celsius: people weighing less than 40 kg, with intestinal disorders, with known swallowing disorders * Patient deprived of liberty, by judicial or administrative decision; * Major protected by law; * Patient in a period of relative exclusion from another protocol or for whom the maximum annual compensation of €4500 has been reached; * Refusal to participate in the protocol.
Where it's running
-
University Hospital, Montpellier
Montpellier, France Recruiting -
University Hospital of Poitiers
Poitiers, France Not yet recruiting -
University Hospital of Toulouse
Toulouse, France Not yet recruiting
Study contacts
- Principal investigator: Karim BENNYS, MD — University Hospital, Montpellier
- Study coordinator: Claire Denis
- Email: claire-denis@chu-montpellier.fr
- Phone: +33467333162
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.