About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Polysomnography
Procedure/SurgeryPolysomnography will be performed for 24 hours at inclusion and 24 months
Neuropsychological assessment
BehavioralA full neuropsychological assessment will be performed at inclusion, 12 and 24 months
Questionnaires on sleep and behavioural problems
BehavioralQuestionnaires on sleep and behavioural problems
Actimetry
Procedure/SurgeryMeasurement of actimetrics for 14 days at inclusion and at 24 months
Fractional diuresis
Diagnostic testSplit diuresis from 7pm-7am, 7am-12am and 12pm-19pm during polysomnography at inclusion inclusion and 24 months to measure melatonin concentration
Internal temperature measurement
Procedure/SurgeryeCelsius capsule to measure internal temperature at inclusion and 24 months
Biomarker assay
Other interventionDetermination of the biomarkers Aβ42, Aβ40, Tau and P-Tau in blood and in the cerebrospinal fluid
Treatment groups
Trial outcomes
Primary outcomes
Change in the Free and Cued Selective Reminding Test (FCSRT) scale score
The FCSRT test evaluates memory, the score obtained is between 0 and 48, higher score mean a better outcome
Secondary outcomes
Change in the Free and Cued Selective Reminding Test (FCSRT) scale score
The FCSRT test evaluates memory, the score obtained is between 0 and 48, higher score mean a better outcome
Cognitive decline in ADCS-PACC composite score
The ADCS-PACC composite score is used to assess cognitive decline
Cognitive decline in the Alzheimer's Disease Cooperative Study- Preclinical Alzheimer Cognitive Composite (ADCS-PACC) composite score
The ADCS-PACC composite score is used to assess cognitive decline
Concentration of proteins involved in Alzheimer disease
Determination of Aβ42, Aβ40, Tau and P-Tau proteins in serum and cerebrospinal fluid
Sponsors and contacts
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University Hospital, Montpellier
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator