Actively Recruiting
Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?
Led by University Hospital, Montpellier · Updated on 2025-10-07
132
Participants Needed
3
Research Sites
219 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Montpellier
Lead Sponsor
I
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of mild Alzheimer's disease with a Mini Mental State (MMS) score between 21 and 30
- Presence of a family carer to help complete neuropsychological scales, questionnaires, and sleep diaries
- Having a neurological assessment and/or follow-up that requires blood and cerebrospinal fluid sampling for biomarkers
- Patient had a lumbar puncture less than one year ago or has a scheduled lumbar puncture as part of care
- Signed informed consent
- Able to attend all visits and follow study procedures
- Affiliated with the French social security system
You will not qualify if you...
- Genetic form of Alzheimer's disease
- Insufficient clinical and paraclinical information for AD diagnosis
- Use of anticholinesterase and/or memantine treatment or stable doses for less than 3 months
- Use of antidepressants, anxiolytics, hypnotics, or neuroleptics within 15 days before inclusion
- Living in a nursing home
- Illiteracy or inability to perform psycho-behavioral tests
- Major physical or neurosensory problems interfering with tests
- Contraindications to lumbar puncture (e.g., spinal surgery, skin infection, coagulation disorders)
- Refusal to undergo diagnostic lumbar puncture
- Contraindication to use of E-Celsius capsule (weight under 40 kg, intestinal or swallowing disorders)
- Patient deprived of liberty by judicial or administrative decision
- Patient legally protected by law
- Participation in another protocol with maximum annual compensation reached
- Refusal to participate in the protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
University Hospital, Montpellier
Montpellier, France
Actively Recruiting
2
University Hospital of Poitiers
Poitiers, France
Not Yet Recruiting
3
University Hospital of Toulouse
Toulouse, France
Not Yet Recruiting
Research Team
C
Claire Denis
CONTACT
Y
Yves Dauvilliers, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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