NCT05629871 · RECRUITING
Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?
This observational study is tracking sleep patterns, body temperature rhythms, and brain biomarkers in people with early-stage Alzheimer's to learn whether sleep disruption is linked to faster cognitive decline. No drug or treatment is being tested — researchers are measuring and watching. It is not a treatment trial at all, more like a detailed scientific observation to understand a connection that could shape future care.
You may qualify if
- 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
You're excluded if
- 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.
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 2025-10-07