Objective Sleep Impairment in APOEε4/ε4 Subjects at Risk of Developing Alzheimer's Disease: Risk Factor for Cognitive Decline?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score
Time Frame: From inclusion to 24 months
The ADCS-PACC scale will be based on scores from the Mini Mental State Examination (MMSE), the Free Recall/Indicated Recall Test, the Digit Substitution Symbol Test, the Wechsler Intelligence Scale for Adults (WAIS-IV), and the 2-minute Verbal Fluency Test
Secondary Outcomes
- Time spent in Rapide Eye Movement (REM) sleep during polysomnography(At inclusion and at 24 months)
- Concentration of proteins involved in Alzheimer disease(At inclusion and at 24 months)
- Sleep time at stage 1-2 during polysomnography(At inclusion and at 24 months)
- Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score(From inclusion to 12 months)
- Cognitive decline in ADCS-PACC composite score(At inclusion and at 12 months)
- Sleep time at stage 3 during polysomnography(At inclusion and at 24 months)
- Apnea Hypopnea index(At inclusion and at 24 months)
- Noctural oxygene saturation (SaO2)(At inclusion and at 24 months)