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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05649514
Other study ID # RECHMPL22_0392
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date December 1, 2027

Study information

Verified date May 2024
Source University Hospital, Montpellier
Contact Yves Dauvilliers, MD
Phone +33467335219
Email y-dauvilliers@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 1, 2027
Est. primary completion date August 1, 2027
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility 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

Study Design


Intervention

Procedure:
Polysomnography
Polysomnography will be performed for 24 hours at inclusion and 24 months
Behavioral:
Neuropsychological assessment
A full neuropsychological assessment will be performed at inclusion, 12 and 24 months
Questionnaires on sleep and behavioural problems
Questionnaires on sleep and behavioural problems
Procedure:
Actimetrics
Measurement of actimetrics for 14 days at inclusion and at 24 months
Other:
Biomarker assay
Determination of the biomarkers Aß42, Aß40, Tau and P-Tau in blood and in the cerebrospinal fluid

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Montpellier Institut National de la Santé Et de la Recherche Médicale, France

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score 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 From inclusion to 24 months
Secondary Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score 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 From inclusion to 12 months
Secondary Cognitive decline in ADCS-PACC composite score The ADCS-PACC composite score is used to assess cognitive decline At inclusion and at 12 months
Secondary Concentration of proteins involved in Alzheimer disease Determination of Aß42, Aß40, Tau and P-Tau proteins in serum and cerebrospinal fluid At inclusion and at 24 months
Secondary Sleep time at stage 1-2 during polysomnography Time spent in stage 1-2 sleep measured in hours and minutes during polysomnography At inclusion and at 24 months
Secondary Sleep time at stage 3 during polysomnography Time spent in stage 3 sleep measured in hours and minutes during polysomnography At inclusion and at 24 months
Secondary Time spent in Rapide Eye Movement (REM) sleep during polysomnography Time spent in REM in hours and minutes during polysomnography At inclusion and at 24 months
Secondary Apnea Hypopnea index The Apnea-Hypopnea Index is calculated from the number of apneas and hypopneas per hour of sleep (AHI = number of apneas + number of hyopneas / number of hours of sleep) during polysomnography At inclusion and at 24 months
Secondary Noctural oxygene saturation (SaO2) The noctural SaO2 is an average of SaO2 values taken during the night. The value is expressed as a percentage and is measured during polysomnography At inclusion and at 24 months
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