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
Qualifiers
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
Treatments tested in this trial
- Polysomnography
- Neuropsychological assessment
- Questionnaires on sleep and behavioural problems
- Actimetry
- Fractional diuresis
- Internal temperature measurement
- Biomarker assay
Treatment groups
Sponsors and collaborators
University Hospital, Montpellier
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator