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Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease (WAVE-APOE4)

Primary Purpose

Neuropathology, Cognitive Decline, Sleep Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Polysomnography
Neuropsychological assessment
Questionnaires on sleep and behavioural problems
Actimetrics
Biomarker assay
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neuropathology focused on measuring cognitive composite score, sleep, biomarkers, cognitive decline

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single arm

    Arm Description

    Prodromal Alzheimer's patients

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    Cognitive decline in ADCS-PACC composite score
    The ADCS-PACC composite score is used to assess cognitive decline
    Concentration of proteins involved in Alzheimer disease
    Determination of Aβ42, Aβ40, Tau and P-Tau proteins in serum and cerebrospinal fluid
    Sleep time at stage 1-2 during polysomnography
    Time spent in stage 1-2 sleep measured in hours and minutes during polysomnography
    Sleep time at stage 3 during polysomnography
    Time spent in stage 3 sleep measured in hours and minutes during polysomnography
    Time spent in Rapide Eye Movement (REM) sleep during polysomnography
    Time spent in REM in hours and minutes during polysomnography
    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
    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

    Full Information

    First Posted
    November 9, 2022
    Last Updated
    December 5, 2022
    Sponsor
    University Hospital, Montpellier
    Collaborators
    Institut National de la Santé Et de la Recherche Médicale, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05649514
    Brief Title
    Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease
    Acronym
    WAVE-APOE4
    Official Title
    Objective Sleep Impairment in APOEε4/ε4 Subjects at Risk of Developing Alzheimer's Disease: Risk Factor for Cognitive Decline?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2027 (Anticipated)
    Study Completion Date
    December 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Montpellier
    Collaborators
    Institut National de la Santé Et de la Recherche Médicale, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neuropathology, Cognitive Decline, Sleep Disorder
    Keywords
    cognitive composite score, sleep, biomarkers, cognitive decline

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single arm
    Arm Type
    Experimental
    Arm Description
    Prodromal Alzheimer's patients
    Intervention Type
    Procedure
    Intervention Name(s)
    Polysomnography
    Intervention Description
    Polysomnography will be performed for 24 hours at inclusion and 24 months
    Intervention Type
    Behavioral
    Intervention Name(s)
    Neuropsychological assessment
    Intervention Description
    A full neuropsychological assessment will be performed at inclusion, 12 and 24 months
    Intervention Type
    Behavioral
    Intervention Name(s)
    Questionnaires on sleep and behavioural problems
    Intervention Description
    Questionnaires on sleep and behavioural problems
    Intervention Type
    Procedure
    Intervention Name(s)
    Actimetrics
    Intervention Description
    Measurement of actimetrics for 14 days at inclusion and at 24 months
    Intervention Type
    Other
    Intervention Name(s)
    Biomarker assay
    Intervention Description
    Determination of the biomarkers Aβ42, Aβ40, Tau and P-Tau in blood and in the cerebrospinal fluid
    Primary Outcome Measure Information:
    Title
    Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score
    Description
    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
    Time Frame
    From inclusion to 24 months
    Secondary Outcome Measure Information:
    Title
    Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score
    Description
    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
    Time Frame
    From inclusion to 12 months
    Title
    Cognitive decline in ADCS-PACC composite score
    Description
    The ADCS-PACC composite score is used to assess cognitive decline
    Time Frame
    At inclusion and at 12 months
    Title
    Concentration of proteins involved in Alzheimer disease
    Description
    Determination of Aβ42, Aβ40, Tau and P-Tau proteins in serum and cerebrospinal fluid
    Time Frame
    At inclusion and at 24 months
    Title
    Sleep time at stage 1-2 during polysomnography
    Description
    Time spent in stage 1-2 sleep measured in hours and minutes during polysomnography
    Time Frame
    At inclusion and at 24 months
    Title
    Sleep time at stage 3 during polysomnography
    Description
    Time spent in stage 3 sleep measured in hours and minutes during polysomnography
    Time Frame
    At inclusion and at 24 months
    Title
    Time spent in Rapide Eye Movement (REM) sleep during polysomnography
    Description
    Time spent in REM in hours and minutes during polysomnography
    Time Frame
    At inclusion and at 24 months
    Title
    Apnea Hypopnea index
    Description
    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
    Time Frame
    At inclusion and at 24 months
    Title
    Noctural oxygene saturation (SaO2)
    Description
    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
    Time Frame
    At inclusion and at 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yves Dauvilliers, MD
    Phone
    +33467335219
    Email
    y-dauvilliers@chu-montpellier.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karim BENNYS, MD
    Organizational Affiliation
    University Hospital, Montpellier
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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