NCT05649514Recruiting
Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease
Objective Sleep Impairment in APOEε4/ε4 Subjects at Risk of Developing Alzheimer's Disease: Risk Factor for Cognitive Decline?
Source: ClinicalTrials.gov · Last updated 27 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 9 Nov 2022
- Start date
- 5 Feb 2025
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- University Hospital, Montpellier
- Diseases
- Alzheimer disease
- NCT number
- NCT05649514
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 5 Feb 2025 to the primary completion date, 1 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Genetic form of alzheimer's disease
- Major depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Short-term life-threatening conditions
Other
- 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 protected by law;
Who the study is looking for
- 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
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.