NCT05629871 Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?
| NCT ID | NCT05629871 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Neuropathology |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2023-04-17 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 132 participants in total. It began in 2023-04-17 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Karim BENNYS, MD
PRINCIPAL INVESTIGATOR
University Hospital, Montpellier
Frequently Asked Questions
Who can join the NCT05629871 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Neuropathology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05629871 currently recruiting?
Yes, NCT05629871 is actively recruiting participants. Contact the research team at claire-denis@chu-montpellier.fr for enrollment information.
Where is the NCT05629871 trial being conducted?
This trial is being conducted at Montpellier, France, Poitiers, France, Toulouse, France.
Who is sponsoring the NCT05629871 clinical trial?
NCT05629871 is sponsored by University Hospital, Montpellier. The principal investigator is Karim BENNYS, MD at University Hospital, Montpellier. The trial plans to enroll 132 participants.