- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01315704
Alzheimer's Disease and Related Disorders (MERE)
March 14, 2011 updated by: University Hospital, Angers
Maladie d'Alzheimer et Maladies apparentées : Caractérisation Des Anomalies Cognitivo-motrices, et Des Effets Des médicaments Anti-démence et de la Vitamine D à Partir de la Mise en Place d'Une Base de données au CMRR du CHU d'Angers
The purpose of this study is to compare characteristics of gait and balance measured among patients with Alzheimer's disease or related disorders separated into 3 groups according to the stage of disease (i.e., pre-dementia, mild and moderate dementia stages); to determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities; and to establish a database at Angers University Memory Centre.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Although gait disorders are frequently associated with Alzheimer's disease and related disorders (ADRD), few studies have focused on cognitive motor effects of anti-dementia drugs and vitamin D.
The objectives of this study are to
- Compare characteristics of gait and balance measured among patients with ADRD separated into 3 groups according to stages of disease (i.e., pre-dementia, mild and moderate dementia stages)
- To determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities
- To determine whether motor abnormalities could be associated with cognitive impairments, specifically executive dysfunctions
- To establish a database at Angers University Memory Center.
Study Type
Observational
Enrollment (Anticipated)
700
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cedric ANNWEILER, DM
- Phone Number: (+33) 241354725
- Email: ceannweiler@chu-angers.fr
Study Locations
-
-
-
Angers, France, 49933
- Recruiting
- Cédric ANNWEILER , MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients of the University Memory Center of Angers University Hospital with respect to the eligibility criteria
Description
Inclusion Criteria:
- All elderly patients from the University Memory Center of Angers University Hospital.
- Able to walk without any walking aid on 15 meters
- Mini-Mental Status Examination score > 10
- Being affiliated to a social security regime
Exclusion Criteria:
- Mini-Mental Status Examination score ≤ 10
- Subject suffering from pre-existing impellent disturbances
- History of cerebrovascular accident or other cerebro-spinal pathology
- Poor workmanship of the written or oral French language
- Use of walking aid such as walking frame with wheels or tricycle.
- Acute medical or surgical disease in the past 3 months
- Refusal to participate (or trustworthy person)
- Near visual acuity < 2/10
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Patients with Mild Cognitive Impairment
|
before-after interventional (anti-dementia drugs and/or vitamin D) study
Other Names:
|
Group 2
Patients with Mild Alzheimer's disease or related disorders
|
before-after interventional (anti-dementia drugs and/or vitamin D) study
Other Names:
|
Group 3
Patients with Moderate Alzheimer's disease or related disorders
|
before-after interventional (anti-dementia drugs and/or vitamin D) study
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Spatiotemporal gait parameters
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cedric ANNWEILER, MD, Memory Centre of Angers University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Beauchet O, Barden J, Liu-Ambrose T, Chester VL, Annweiler C, Szturm T, Grenier S, Leonard G, Bherer L, Allali G; Canadian Gait Consortium. Anti-Dementia Drugs, Gait Performance and Mental Imagery of Gait: A Non-Randomized Open-Label Trial. Drugs Aging. 2016 Sep;33(9):665-73. doi: 10.1007/s40266-016-0391-0.
- Beauchet O, Launay CP, Allali G, Watfa G, Gallouj K, Herrmann FR, Annweiler C. Anti-dementia drugs and changes in gait: a pre-post quasi-experimental pilot study. BMC Neurol. 2013 Nov 21;13:184. doi: 10.1186/1471-2377-13-184.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Anticipated)
November 1, 2017
Study Completion (Anticipated)
November 1, 2017
Study Registration Dates
First Submitted
March 11, 2011
First Submitted That Met QC Criteria
March 14, 2011
First Posted (Estimate)
March 15, 2011
Study Record Updates
Last Update Posted (Estimate)
March 15, 2011
Last Update Submitted That Met QC Criteria
March 14, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Psychomotor Disorders
- Dementia
- Tauopathies
- Cognition Disorders
- Gait Disorders, Neurologic
- Alzheimer Disease
- Cognitive Dysfunction
- Apraxias
- Gait Apraxia
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Vitamin D
Other Study ID Numbers
- 2009-15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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