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NCT05649514
Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease
Conditions: Neuropathology, Cognitive Decline, Sleep Disorder
Sex: All
Ages: 50 Years – 85 Years
Phase: NA
Enrollment: 50
Sponsor: University Hospital, Montpellier
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.
Eligibility Criteria
Inclusion Criteria:Diagnosis of mild Alzheimer's disease with a MMS between 21-30Without anticholinesterase and/or memantine treatment or on stable doses for at least 3 monthsNo antidepressant or anxiolytic treatment or stopped for at least 15 daysThe presence of a family carer to complete neuropsychological scales, questionnaires and sleep diariesSigned informed consentAble to carry out all visits and follow study proceduresAffiliation to the French social security systemExclusion Criteria:Genetic form of alzheimer's diseaseInsufficient clinical and paraclinical information for the diagnosis of ADPatient living in a nursing homeIlliteracy or inability to perform psycho-behavioural testsMajor physical or neurosensory problems that may interfere with the testsPatient 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
Source: ClinicalTrials.gov (NCT05649514). StuddyBuddy aggregates publicly available trial information.