Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease

Cognitive Decline Clinical Trial

— WAVE-APOE4  

Official title:

Objective Sleep Impairment in APOEε4/ε4 Subjects at Risk of Developing Alzheimer's Disease: Risk Factor for Cognitive Decline?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05649514
• Other study ID #: RECHMPL22_0392
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Decline
• Cognitive Dysfunction
• Neuropathology
• Sleep Disorder
• Sleep Wake Disorders

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