Alzheimer DiseaseAMImage3NCT04044495
Sleep, Rhythms and Risk of Alzheimer's Disease
A study testing Multimodal brain imaging (MRI), Actimetry and Sleep Diary in people with Alzheimer Disease and Sleep, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Alterations in sleep and the sleep / wake cycle, which are particularly common in Alzheimer's disease patients, could represent an early biomarker for cognitive decline and onset of dementia . Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease, Sleep
- What is being tested?
- Multimodal brain imaging (MRI), Actimetry and Sleep Diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2019to 22 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Belonging to AMImage 2 cohort and preferentially belonging to subjects included in the first actimetric assessment. AMI subjects have been selected based on Mutualité Sociale Agricole of Gironde (agricultural Health Insurance system database as followed :
- >65 years old
- Retired from agriculture
- Living in Gironde countryside
- Being affiliated to the French Farmers Health Insurance
- Signed Informed Consent
Who cannot join
- Left Handed subjects
- Severe dementia (MMSE<13)
- Stroke
- Parkinson's disease
- MRI contraindication
- Health state not allowing displacement to the hospital
- Person under gardianship and not able to give its informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Sleep, Rhythms and Risk of Alzheimer's Disease: a Daily Life Actigraphic Assessment and MRI Study" "SoRyMA - AMImage3"
Alterations in sleep and the sleep / wake cycle, which are particularly common in Alzheimer's disease patients, could represent an early biomarker for cognitive decline and onset of dementia . Moreover, these disturbances in activity rhythms and sleep patterns represent modifiable factors and therefore potential targets for the prevention of certain neurodegenerative disorders.
The main objective of this study will be to test the hypothesis that elderly people without major cognitive impairment who have circadian rhythm disorders of the sleep / wake cycle have structural and / or functional abnormalities in the central nervous system and more specifically of the hippocampal function which could represent a risk factor for the occurrence of cognitive impairment. Indeed, although many studies in both humans and animals suggest the existence of links between sleep alterations and age-related cognitive impairment, the causality of these observations is still not clear.
Read more
This description of the anatomical and functional substratum of sleep / wake cycle alterations occurring in an elderly population will be based on joint analysis of multimodal brain imaging (MRI) and neuropsychology actimetry data. The SoRyMA-AMImage 3 protocol will correspond to the 2nd actimetry measurement point and the 3rd MRI measurement point of a larger population-based cohort AMImage.
This project will collect data from the sleep / wake cycle (actimetry) from a sample of 100 patients included in AMI / AMImage 2 and relate them to brain imaging data (MRI). The main objective of the protocol is the evaluation of the link between changes in sleep and cycle parameters during aging and hippocampal functioning (through fMRI and neuropsychological score of hippocampal dependant tasks). The actimetry variables measured at the two follow-up (4 years apart) will make it possible to measure the degradation of the sleep and cycle parameters (through the reduction of sleep duration, sleep time, increase in sleep fragmentation and decrease in the relative amplitude of the rhythm).
This framework will provide access to a very large amount of data that can be cross-referenced with actimetry data; the longitudinal character of this data collected over a decade will also make it possible to work on the evolution of the actimetry parameters and its relationship with the cognitive and clinical evolution of the subjects. Thus, these data will make it possible to study the prognostic value of the analyzed actimetry parameters in association with very complete clinical and neuropsychological data.
- Conditions
- Alzheimer Disease, Sleep
- Being tested
- Multimodal brain imaging (MRI), Actimetry, Sleep Diary
- Keywords
- Aging, Sleep/wake Cycle, Hippocampal connectivity, Hippocampal dependant Memory tests, Actigraphy, Functional and structural MRI
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal brain imaging (MRI)Other
Multimodal brain imaging (MRI)
ActimetryOther
7 days actimetry
Sleep DiaryOther
7 days Record of sleep and wake cycle
| Study group | Role | What they receive |
|---|---|---|
| Sample of 100 persons included in AMI / AMImage 2 | Experimental | Sample of 100 persons included in AMI / AMImage 2 Receives: Other: Multimodal brain imaging (MRI); Other: Actimetry; Other: Sleep Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bold Signal
Bold Signal on Magnetic Resonance Imaging (MRI)
Measured: Day 1
Secondary outcomes (8)
Pittsburgh Sleep Quality Index (PSQI) Score
seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality
Measured: Day 1
Mannheim Dream questionnaire (MADRE)
MADRE questionnaire evaluates dream recall frequency, emotional aspects of dreams (intensity and tonality), nightmares, lucid dreaming, attitude towards dreams, effects of dreams on waking life and dream literature reading and has been demonstrated to show high retest reliability
Measured: Day 1
Epworth Sleepiness Scale
The test is a list of eight situations in which is rate the tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing
Measured: Day 1
Toronto Alexithymia Scale (TAS-20)
The TAS-20 is a self-report scale that is comprised of 20 items.
The TAS-20 has 3 subscales:
- Difficulty Describing Feelings subscale is used to measure difficulty describing emotions. 5 items.
- Difficulty Identifying Feeling subscale is used to measure difficulty identifying emotions. 7 items.
- Externally-Oriented Thinking subscale is used to measure the tendency of individuals to focus their attention externally. 8 items.
Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree.
The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
Measured: Day 1
Positive and Negative Affective Scale (PANAS)
The PANAS Scale or Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire. The test comprises 20 terms, with ten focusing on a positive emotion and the other ten focusing on a negative emotion. The final score of the PANAS Scale / Positive and Negative Affect Schedule (PANAS) test is the sum of the 10 terms on the positive scale and the sum of the 10 terms on the negative scale. The value assigned is positive for answers on the positive scale and negative for answers on the negative scale.
Measured: Day 1
Emotional Regulation Questionnaire (ERQ)
10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). The scoring takes the average of all the scores.
Measured: Day 1
Actimetry
Automatically record of waking and sleeping periods on 7 consecutive days
Measured: Up to 7 days
Sleep diary
Series of questions for each 24-hour period with a collection of bedtime, wake-up time, possible night awakenings or even naps
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start9 Sep 2019
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henri de CLERMONT-GALLERANDE, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044495
- Sponsor's protocol ID
- CHUBX 2018/15
- Other IDs
- 2019-A00253-54
- Acronym
- AMImage3
- Status last verified
- Mar 2022
- First submitted
- 25 Jul 2019
- Last updated
- 1 Jun 2026
- 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Sleep, Rhythms and Risk of Alzheimer's Disease: a Daily Life Actigraphic Assessment and MRI Study" "SoRyMA - AMImage3"
- ClinicalTrials.gov ID
- NCT04044495
- Acronym / sponsor ID
- AMImage3 / CHUBX 2018/15
- Conditions
- Alzheimer Disease, Sleep
- Keywords
- Aging, Sleep/wake Cycle, Hippocampal connectivity, Hippocampal dependant Memory tests, Actigraphy, Functional and structural MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 5 Aug 2019 (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.
Alterations in sleep and the sleep / wake cycle, which are particularly common in Alzheimer's disease patients, could represent an early biomarker for cognitive decline and onset of dementia . Moreover, these disturbances in activity rhythms and sleep patterns represent modifiable factors and therefore potential targets for the prevention of certain neurodegenerative disorders.
The main objective of this study will be to test the hypothesis that elderly people without major cognitive impairment who have circadian rhythm disorders of the sleep / wake cycle have structural and / or functional abnormalities in the central nervous system and more specifically of the hippocampal function which could represent a risk factor for the occurrence of cognitive impairment. Indeed, although many studies in both humans and animals suggest the existence of links between sleep alterations and age-related cognitive impairment, the causality of these observations is still not clear.
This description of the anatomical and functional substratum of sleep / wake cycle alterations occurring in an elderly population will be based on joint analysis of multimodal brain imaging (MRI) and neuropsychology actimetry data. The SoRyMA-AMImage 3 protocol will correspond to the 2nd actimetry measurement point and the 3rd MRI measurement point of a larger population-based cohort AMImage.
This project will collect data from the sleep / wake cycle (actimetry) from a sample of 100 patients included in AMI / AMImage 2 and relate them to brain imaging data (MRI). The main objective of the protocol is the evaluation of the link between changes in sleep and cycle parameters during aging and hippocampal functioning (through fMRI and neuropsychological score of hippocampal dependant tasks). The actimetry variables measured at the two follow-up (4 years apart) will make it possible to measure the degradation of the sleep and cycle parameters (through the reduction of sleep duration, sleep time, increase in sleep fragmentation and decrease in the relative amplitude of the rhythm).
This framework will provide access to a very large amount of data that can be cross-referenced with actimetry data; the longitudinal character of this data collected over a decade will also make it possible to work on the evolution of the actimetry parameters and its relationship with the cognitive and clinical evolution of the subjects. Thus, these data will make it possible to study the prognostic value of the analyzed actimetry parameters in association with very complete clinical and neuropsychological data.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample of 100 persons included in AMI / AMImage 2 | Experimental | Other: Multimodal brain imaging (MRI), Other: Actimetry, Other: Sleep DiarySample of 100 persons included in AMI / AMImage 2 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Belonging to AMImage 2 cohort and preferentially belonging to subjects included in the first actimetric assessment. AMI subjects have been selected based on Mutualité Sociale Agricole of Gironde (agricultural Health Insurance system database as followed :
- Signed Informed Consent
Key exclusion criteria (7 listed)
- Left Handed subjects
- Severe dementia (MMSE<13)
- Stroke
- Parkinson's disease
- MRI contraindication
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 |
|---|---|---|
| Multimodal brain imaging (MRI)Multimodal brain imaging (MRI) | Other | Sample of 100 persons included in AMI / AMImage 2 |
| Actimetry7 days actimetry | Other | Sample of 100 persons included in AMI / AMImage 2 |
| Sleep Diary7 days Record of sleep and wake cycle | Other | Sample of 100 persons included in AMI / AMImage 2 |
Primary outcome
Bold Signal
Time frame: Day 1
Bold Signal on Magnetic Resonance Imaging (MRI)
8 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Day 1
Mannheim Dream questionnaire (MADRE)
Time frame: Day 1
Epworth Sleepiness Scale
Time frame: Day 1
Toronto Alexithymia Scale (TAS-20)
Time frame: Day 1
Positive and Negative Affective Scale (PANAS)
Time frame: Day 1
Emotional Regulation Questionnaire (ERQ)
Time frame: Day 1
Actimetry
Time frame: Up to 7 days
Sleep diary
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- 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. This study is not recruiting at the moment.
Henri de CLERMONT-GALLERANDE principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal brain imaging (MRI), Actimetry and Sleep Diary in people with Alzheimer Disease and Sleep, run by University Hospital, Bordeaux 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 1 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bold Signal (time frame: Day 1). 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 1 Jun 2026.