Clinical trial NCT05649514: Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease
Official title: Objective Sleep Impairment in APOEε4/ε4 Subjects at Risk of Developing Alzheimer's Disease: Risk Factor for Cognitive Decline?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neuropathology
Cognitive Decline
Sleep Disorder
Keywords: cognitive composite score
sleep
biomarkers
cognitive decline
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2022-12-14
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score
timeFrame: From inclusion to 24 months
Secondary outcomes:
measure: Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score
timeFrame: From inclusion to 12 months
measure: Cognitive decline in ADCS-PACC composite score
timeFrame: At inclusion and at 12 months
measure: Concentration of proteins involved in Alzheimer disease
timeFrame: At inclusion and at 24 months
measure: Sleep time at stage 1-2 during polysomnography
timeFrame: At inclusion and at 24 months
measure: Sleep time at stage 3 during polysomnography
timeFrame: At inclusion and at 24 months
measure: Time spent in Rapide Eye Movement (REM) sleep during polysomnography
timeFrame: At inclusion and at 24 months
measure: Apnea Hypopnea index
timeFrame: At inclusion and at 24 months
measure: Noctural oxygene saturation (SaO2)
timeFrame: At inclusion and at 24 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Montpellier
name: Karim BENNYS, MD
role: PRINCIPAL_INVESTIGATOR
References: