- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00831298
Assessment of Sleep Disturbance in Alzheimer Disease
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nice, France, 06000
- Centre Mémoire de Ressources et de Recherche, CHU de Nice
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- alzheimer disease
- MMSE > 20
- over 65 years old
Exclusion Criteria:
- new psychotropic drug treatment
- patient unable to do neuropsychologic tests
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 1
Behavioral Questionnaire Sleep Recordings Genetic analysis
|
Behavioral Questionnaire Sleep Recordings Genetic analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
assessment of apathy
Time Frame: at day 0, just after inclusion
|
at day 0, just after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
assessment of sleep disturbance
Time Frame: during a week, between day 0 and day 7
|
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
|
after all genetic analyses of the study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Philippe ROBERT, Centre Hospitalier Universitaire De Nice
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Dementia
- Tauopathies
- Neurodegenerative Diseases
- Sleep Wake Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Alzheimer Disease
- Parasomnias
- Memory Disorders
- Lethargy
Other Study ID Numbers
- 08-PP-07
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