Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease

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.

Treatment protocols in the field of Alzheimer's disease (AD) are directed towards participants at risk of developing the disease, such as those who carry at least one ε4 allele on apolipoprotein E (APOE ε4). An individual with 2 ε4 copies has a 30-55% risk of developing AD with an age of onset around 68 years and a dose effect of the allele on risk and age of onset of symptoms.

Eligibility criteria

Qualifiers

Diagnosis of mild Alzheimer's disease with a MMS between 21-30

Without anticholinesterase and/or memantine treatment or on stable doses for at least 3 months

No antidepressant or anxiolytic treatment or stopped for at least 15 days

The presence of a family carer to complete neuropsychological scales, questionnaires and sleep diaries

Disqualifiers

Genetic form of alzheimer's disease

Insufficient clinical and paraclinical information for the diagnosis of AD

Patient living in a nursing home

Illiteracy or inability to perform psycho-behavioural tests

Trial design

Treatments tested in this trial

  • Polysomnography
  • Neuropsychological assessment
  • Questionnaires on sleep and behavioural problems
  • Actimetrics
  • Biomarker assay

Treatment groups

50 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