NeuropathologyWAVE-APOE4NCT05649514
Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease
A study testing Polysomnography, Neuropsychological assessment and Questionnaires on sleep and behavioural problems in people with Neuropathology and Cognitive Decline, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Neuropathology, Cognitive Decline, Sleep Disorder
- What is being tested?
- Polysomnography, Neuropsychological assessment and Questionnaires on sleep and behavioural problems
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- Major depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Major protected by law;
- Short-term life-threatening conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Montpellier
Montpellier, Hérault, 34000
Yves DAUVILLIERS
About this study
Official title: Objective Sleep Impairment in APOEε4/ε4 Subjects at Risk of Developing Alzheimer's Disease: Risk Factor for Cognitive Decline?
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.
- Conditions
- Neuropathology, Cognitive Decline, Sleep Disorder
- Being tested
- Polysomnography, Neuropsychological assessment, Questionnaires on sleep and behavioural problems, Actimetrics, Biomarker assay
- Keywords
- cognitive composite score, sleep, biomarkers, cognitive decline
- Medical subject headings
- Cognitive Dysfunction, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyProcedure or surgery
Polysomnography will be performed for 24 hours at inclusion and 24 months
Neuropsychological assessmentBehavioural
A full neuropsychological assessment will be performed at inclusion, 12 and 24 months
Questionnaires on sleep and behavioural problemsBehavioural
Questionnaires on sleep and behavioural problems
ActimetricsProcedure or surgery
Measurement of actimetrics for 14 days at inclusion and at 24 months
Biomarker assayOther
Determination of the biomarkers Aβ42, Aβ40, Tau and P-Tau in blood and in the cerebrospinal fluid
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Prodromal Alzheimer's patients Receives: Procedure: Polysomnography; Behavioral: Neuropsychological assessment; Behavioral: Questionnaires on sleep and behavioural problems; Procedure: Actimetrics; Other: Biomarker assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From inclusion to 24 months
Secondary outcomes (8)
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
Measured: From inclusion to 12 months
Cognitive decline in ADCS-PACC composite score
The ADCS-PACC composite score is used to assess cognitive decline
Measured: At inclusion and at 12 months
Concentration of proteins involved in Alzheimer disease
Determination of Aβ42, Aβ40, Tau and P-Tau proteins in serum and cerebrospinal fluid
Measured: At inclusion and at 24 months
Sleep time at stage 1-2 during polysomnography
Time spent in stage 1-2 sleep measured in hours and minutes during polysomnography
Measured: At inclusion and at 24 months
Sleep time at stage 3 during polysomnography
Time spent in stage 3 sleep measured in hours and minutes during polysomnography
Measured: At inclusion and at 24 months
Time spent in Rapide Eye Movement (REM) sleep during polysomnography
Time spent in REM in hours and minutes during polysomnography
Measured: At inclusion and at 24 months
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
Measured: At inclusion and at 24 months
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
Measured: At inclusion and at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start5 Feb 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuropathologyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim BENNYS, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649514
- Sponsor's protocol ID
- RECHMPL22_0392
- Acronym
- WAVE-APOE4
- Status last verified
- Jun 2025
- First submitted
- 9 Nov 2022
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Sleep Impairment in APOEε4/ε4 Subjects at Risk of Developing Alzheimer's Disease: Risk Factor for Cognitive Decline?
- ClinicalTrials.gov ID
- NCT05649514
- Acronym / sponsor ID
- WAVE-APOE4 / RECHMPL22_0392
- Conditions
- Neuropathology, Cognitive Decline, Sleep Disorder
- Keywords
- cognitive composite score, sleep, biomarkers, cognitive decline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Procedure: Polysomnography, Behavioral: Neuropsychological assessment, Behavioral: Questionnaires on sleep and behavioural problems, Procedure: Actimetrics, Other: Biomarker assayProdromal Alzheimer's patients |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographyPolysomnography will be performed for 24 hours at inclusion and 24 months | Procedure or surgery | Single arm |
| Neuropsychological assessmentA full neuropsychological assessment will be performed at inclusion, 12 and 24 months | Behavioural | Single arm |
| Questionnaires on sleep and behavioural problemsQuestionnaires on sleep and behavioural problems | Behavioural | Single arm |
| ActimetricsMeasurement of actimetrics for 14 days at inclusion and at 24 months | Procedure or surgery | Single arm |
| Biomarker assayDetermination of the biomarkers Aβ42, Aβ40, Tau and P-Tau in blood and in the cerebrospinal fluid | Other | Single arm |
Primary outcome
Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score
Time frame: From inclusion to 24 months
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
8 secondary outcomes
Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score
Time frame: From inclusion to 12 months
Cognitive decline in ADCS-PACC composite score
Time frame: At inclusion and at 12 months
Concentration of proteins involved in Alzheimer disease
Time frame: At inclusion and at 24 months
Sleep time at stage 1-2 during polysomnography
Time frame: At inclusion and at 24 months
Sleep time at stage 3 during polysomnography
Time frame: At inclusion and at 24 months
Time spent in Rapide Eye Movement (REM) sleep during polysomnography
Time frame: At inclusion and at 24 months
Apnea Hypopnea index
Time frame: At inclusion and at 24 months
Noctural oxygene saturation (SaO2)
Time frame: At inclusion and at 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karim BENNYS, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography, Neuropsychological assessment and Questionnaires on sleep and behavioural problems in people with Neuropathology and Cognitive Decline, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yves Dauvilliers, MD (+33467335219, y-dauvilliers@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score (time frame: From inclusion to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.