Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?
- Conditions
- Neuropathology
- Interventions
- Procedure: PolysomnographyBehavioral: Neuropsychological assessmentBehavioral: Questionnaires on sleep and behavioural problemsProcedure: ActimetryDiagnostic Test: Fractional diuresisProcedure: Internal temperature measurementOther: Biomarker assay
- Registration Number
- NCT05629871
- Lead Sponsor
- University Hospital, Montpellier
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 132
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm Polysomnography Alzheimer Single arm Questionnaires on sleep and behavioural problems Alzheimer Single arm Actimetry Alzheimer Single arm Internal temperature measurement Alzheimer Single arm Fractional diuresis Alzheimer Single arm Biomarker assay Alzheimer Single arm Neuropsychological assessment Alzheimer
- Primary Outcome Measures
Name Time Method Change in the Free and Cued Selective Reminding Test (FCSRT) scale score From inclusion to 24 months The FCSRT test evaluates memory, the score obtained is between 0 and 48, higher score mean a better outcome
- Secondary Outcome Measures
Name Time Method Cognitive decline in ADCS-PACC composite score At inclusion and at 24 months The ADCS-PACC composite score is used to assess cognitive decline
Sleep time at stage 3 during polysomnography At inclusion and at 24 months Time spent in stage 3 sleep measured in hours and minutes during polysomnography
Time spent in Rapid eye movement (REM) sleep during polysomnography At inclusion and at 24 months Time spent in stage 3 sleep measured in hours and minutes during polysomnography
Change in the Free and Cued Selective Reminding Test (FCSRT) scale score From inclusion to 12 months The FCSRT test evaluates memory, the score obtained is between 0 and 48, higher score mean a better outcome
Concentration of proteins involved in Alzheimer disease At inclusion and at 24 months Determination of Aβ42, Aβ40, Tau and P-Tau proteins in serum and cerebrospinal fluid
Concentration of orexinA/hypocretin At inclusion and at 24 months Determination in serum and cerebrospinal fluid
Changes in sleep duration At inclusion and at 24 months Average sleep duration (in hours and minutes) over a 14-day period from inclusion to M24 measured by actimetry
Urinary melatonin concentration At inclusion and at 24 months Fractional diuresis
Cognitive decline in the Alzheimer's Disease Cooperative Study- Preclinical Alzheimer Cognitive Composite (ADCS-PACC) composite score At inclusion and at 12 months The ADCS-PACC composite score is used to assess cognitive decline
Sleep time at stage 1-2 during polysomnography At inclusion and at 24 months Time spent in stage 1-2 sleep measured in hours and minutes during polysomnography
Apnea Hypopnea Index At inclusion and at 24 months The Apnea-Hypopnea Index is calculated from the number of apneas and hypopneas per hour of sleep (AHI = number of apneas + number of hypopneas / number of hours of sleep) during polysomnography
Nocturnal oxygen saturation (SaO2) At inclusion and at 24 months The nocturnal SaO2 is an average of SaO2 values taken during the night. The value is expressed as a percentage and is measured during polysomnography
Internal temperature At inclusion and at 24 months The internal temperature will be measured with an e-Celsius capsule during polysomnography
Trial Locations
- Locations (3)
University Hospital, Montpellier
🇫🇷Montpellier, France
University Hospital of Poitiers
🇫🇷Poitiers, France
University Hospital of Toulouse
🇫🇷Toulouse, France