Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease
Recruiting · NCT05649514 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Montpellier
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
- Signed informed consent
- Able to carry out all visits and follow study procedures
- Affiliation to the French social security system
Exclusion criteria
- 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
- Major physical or neurosensory problems that may interfere with the tests
- Patient deprived of liberty, by judicial or administrative decision;
- Major depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Major protected by law;
- Short-term life-threatening conditions
Where it is running
1 location listed.
- CHU de Montpellier - Montpellier, Hérault, France