Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorUniversity Hospital, Montpellier

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

132 Participants
are divided into 1 treatment group

Sponsors and collaborators

University Hospital, Montpellier

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborator