Alzheimer DiseaseNCT00831298
Assessment of Sleep Disturbance in Alzheimer Disease
A study testing Analysis of sleep disturbance in people with Alzheimer Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The purpose of this study is to study circadian rhythms, or daily cycles of sleep, wake, and activity. The investigators hope to learn how disturbed sleep in Alzheimer's Disease relates to changes in activity cycles, and how sleep disturbances may affect your daytime alertness. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Analysis of sleep disturbance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2010to Nov 2011
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- alzheimer disease
- MMSE > 20
- over 65 years old
Who cannot join
- new psychotropic drug treatment
- patient unable to do neuropsychologic tests
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Mémoire de Ressources et de Recherche, CHU de Nice
Nice, 06000
About this study
The purpose of this study is to study circadian rhythms, or daily cycles of sleep, wake, and activity. The investigators hope to learn how disturbed sleep in Alzheimer's Disease relates to changes in activity cycles, and how sleep disturbances may affect your daytime alertness.
This project selects patients suffering from memory problems, or voluntary to be in our Control Group. There are three parts to this study: Sleep Diaries, Behavioral Questionnaire, and Activity Recordings
- Conditions
- Alzheimer Disease
- Being tested
- Analysis of sleep disturbance
- Keywords
- alzheimer disease, sleep disturbance, apathy, memory loss
- Medical subject headings
- Alzheimer Disease, Parasomnias, Lethargy, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of sleep disturbanceOther
Behavioral Questionnaire Sleep Recordings Genetic analysis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Behavioral Questionnaire Sleep Recordings Genetic analysis Receives: Other: Analysis of sleep disturbance |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of apathy
Measured: at day 0, just after inclusion
Secondary outcomes (2)
assessment of sleep disturbance
Measured: during a week, between day 0 and day 7
determine a genetic relationship between sleep disturbance and alzheimer disease
Measured: after all genetic analyses of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startJul 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe ROBERT, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831298
- Sponsor's protocol ID
- 08-PP-07
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2009
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Ettore E, Bakardjian H, Sole M, Levy Nogueira M, Habert MO, Gabelle A, Dubois B, Robert P, David R. Relationships between objectives sleep parameters and brain amyloid load in subjects at risk for Alzheimer's disease: the INSIGHT-preAD Study. Sleep. 2019 Sep 6;42(9):zsz137. doi: 10.1093/sleep/zsz137.
PubMed 31267124
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sleep Disturbance in Alzheimer Disease
- ClinicalTrials.gov ID
- NCT00831298
- Acronym / sponsor ID
- 08-PP-07
- Conditions
- Alzheimer Disease
- Keywords
- alzheimer disease, sleep disturbance, apathy, memory loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 28 Jan 2009 (estimated)
- 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.
The purpose of this study is to study circadian rhythms, or daily cycles of sleep, wake, and activity. The investigators hope to learn how disturbed sleep in Alzheimer's Disease relates to changes in activity cycles, and how sleep disturbances may affect your daytime alertness.
This project selects patients suffering from memory problems, or voluntary to be in our Control Group. There are three parts to this study: Sleep Diaries, Behavioral Questionnaire, and Activity Recordings
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Analysis of sleep disturbanceBehavioral Questionnaire Sleep Recordings Genetic analysis |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- alzheimer disease
- MMSE > 20
- over 65 years old
Key exclusion criteria (2 listed)
- new psychotropic drug treatment
- patient unable to do neuropsychologic 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 |
|---|---|---|
| Analysis of sleep disturbanceBehavioral Questionnaire Sleep Recordings Genetic analysis | Other | 1 |
Primary outcome
assessment of apathy
Time frame: at day 0, just after inclusion
2 secondary outcomes
assessment of sleep disturbance
Time frame: during a week, between day 0 and day 7
determine a genetic relationship between sleep disturbance and alzheimer disease
Time frame: after all genetic analyses of the study
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 31 Mar 2026.
- Results publication: PubMed 31267124Ettore E, Bakardjian H, Sole M, Levy Nogueira M, Habert MO, Gabelle A, Dubois B, Robert P, David R. Relationships between objectives sleep parameters and brain amyloid load in subjects at risk for Alzheimer's disease: the INSIGHT-preAD Study. Sleep. 2019 Sep 6;42(9):zsz137. doi: 10.1093/sleep/zsz137.
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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.
Philippe ROBERT principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysis of sleep disturbance in people with Alzheimer Disease, run by Centre Hospitalier Universitaire de Nice 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 3 inclusion and 2 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 31 Mar 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?
assessment of apathy (time frame: at day 0, just after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00831298, which also lists 1 linked publication.
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 31 Mar 2026.