NCT05629871Recruiting

Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?

Source: ClinicalTrials.gov · Last updated 7 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Alzheimer's disease (AD) is characterised by a progressive loss of memory and cognitive function. In the early stages of AD, there is a progressive accumulation of molecules: β-amyloid peptides (Aβ) in the brain. There is a link between the accumulation of Aβ peptides and the deterioration of sleep, but current knowledge does not confirmed this link. The objective of this study is to define whether there is a link between cognitive decline and sleep disorders. If a correlation is found, this could allow earlier treatment of sleep disorders in the longer term in order to slow the development of AD.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 132 (estimated)
First submitted: 28 Oct 2022
Start date: 17 Apr 2023
Primary completion date: 1 Jul 2027
Lead sponsor: University Hospital, Montpellier
Diseases: Alzheimer disease
NCT number: NCT05629871

What you commit to

Study type: Interventional
Planned participants: 132
From 17 Apr 2023 to the primary completion date, 1 Jul 2027
3 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Use of antidepressants, anxiolytics, hypnotics, neuroleptics, 15 days before inclusion

Other illness

Genetic form of alzheimer's disease
Initial contraindication to diagnostic lumbar puncture (LP) (spinal surgery, skin infection, haemostasis abnormality, intracranial hypertension, severe coagulation disorders, curative anticoagulant therapy, severe liver failure)
Contraindication to the use of E-Celsius: people weighing less than 40 kg, with intestinal disorders, with known swallowing disorders

Other

Insufficient clinical and paraclinical information for the diagnosis of AD
Anticholinesterase and/or memantine treatment or on stable doses for at least 3 months
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
Refusal to perform a diagnostic lumbar puncture
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.

Who the study is looking for

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

Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University Hospital, Montpellier Coordinator of this site? Confirm its status	Montpellier	France	Recruiting
University Hospital of Poitiers Coordinator of this site? Confirm its status	Poitiers	France	Not yet recruiting
University Hospital of Toulouse Coordinator of this site? Confirm its status	Toulouse	France	Not yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.