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
N/A
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 marked by a gradual loss of memory and thinking skills. Early in AD, certain molecules called beta-amyloid peptides build up in the brain. This study aims to explore if there is a connection between cognitive decline and sleep problems in people with mild Alzheimer's disease. Discovering such a link may help in developing earlier treatments for sleep issues to possibly slow AD progression. Participants will undergo various assessments including 24-hour sleep studies (polysomnography) and actimetry to monitor activity over 14 days, both at the start and after 24 months. Neuropsychological testing and questionnaires about sleep and behavior will be done at the start, 12 months, and 24 months. Additional tests include measuring internal body temperature and analyzing biomarkers from blood and cerebrospinal fluid samples. During the study, participants will be monitored with sleep studies, cognitive tests, urine collection to measure melatonin, and biomarker assays to track changes over two years. Researchers will measure changes in memory and cognition using specific tests like the Free and Cued Selective Reminding Test. Safety and adherence will be checked throughout the 24-month participation period to better understand the role of sleep in cognitive decline.
CONDITIONS
Brief 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 score between 21 and 30
- 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 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 will not qualify if you...
- Genetic form of Alzheimer's disease
- Insufficient clinical and paraclinical information for the diagnosis of Alzheimer's disease
- Taking anticholinesterase and/or memantine treatment or on stable doses for at least 3 months
- Use of antidepressants, anxiolytics, hypnotics, or neuroleptics within 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 tests
- Contraindications to diagnostic lumbar puncture (e.g., spinal surgery, skin infection, coagulation disorders)
- Refusal to perform diagnostic lumbar puncture
- Contraindication to the use of E-Celsius capsule (weight under 40 kg, intestinal or swallowing disorders)
- Patient deprived of liberty by judicial or administrative decision
- Major protected by law
- Patient currently excluded from another protocol or exceeded maximum annual compensation of €4500
- Refusal to participate in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day for initial assessments
Participants undergo a series of diagnostic procedures including polysomnography, neuropsychological assessments, questionnaires on sleep and behavioral problems, actimetry measurements, fractional diuresis for melatonin concentration, internal temperature measurement, and biomarker assays at inclusion.
1 baseline visit (in-person) including overnight polysomnography and 14 days of actimetry monitoring
Duration - 24 months
Participants are monitored over 24 months with repeated assessments including polysomnography, neuropsychological tests, questionnaires, actimetry, fractional diuresis, internal temperature measurement, and biomarker assays to evaluate cognitive decline and sleep-wake cycle changes.
Follow-up visits at 12 and 24 months with 24-hour polysomnography and 14-day actimetry periods, plus a neuropsychological assessment at 12 months
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
Y
Yves Dauvilliers, MD
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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