- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01315717
Gait and Alzheimer Interaction Tracking (GAIT) Study (GAIT)
Maladie d'Alzheimer et Troubles Locomoteurs : Caracterisation Des Anomalies Temporelles de la Marche et Etude Des Correlats Anatomo-cognitifs
Study Overview
Status
Detailed Description
Although gait disorders are frequently associated with Alzheimer's disease (AD), few studies have focused on their characterization and mechanism. Exploring the associations of the gait characteristics - more particularly the gait variability - with the cognitive performance of AD patients on one hand, and with the morphological brain abnormalities on the other hand, could be useful to understanding the mechanisms of gait disorders in AD.
The main objective of this study is to examine and to compare gait characteristics under single- and dual-task conditions among healthy subjects together with AD patients at different stages of disease (i.e., pre-dementia, mild and moderate dementia stages).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Angers, France, 49933
- Angers University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 60 years
- Able to walk without walking aid on 15 metres
- Score of Mini-Mental Examination (MMSE) > 10
- Written informed consent to participate in the study (or trustworthy person)
- Being affiliated to a social security regime
- Near visual acuity ≥ 2/10
- Absence of severe depression (score in the 15-item Geriatric Depression Scale ≤ 10)
Exclusion Criteria:
- Score of Mini-Mental Examination (MMSE) ≤ 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
- Refusal of subject to be informed on possible hanging bare anomaly during study
- Use of walking aid
- Acute medical or surgical disease in the past 3 months
- Refusal to participate (or trustworthy person)
- Contra-indication to the achievement of a Magnetic Resonance Imaging
- Near visual acuity < 2/10
- Presence of severe depression (score in the 15-item Geriatric Depression Scale > 10)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Group 1
Healthy subjects
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Group 2
Patients with Mild Cognitive Impairment
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Group 3
Patients with Mild AD
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Group 4
Patients with Moderate AD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stride-to-stride variability of stride time
Time Frame: baseline
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baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olivier Beauchet, MD, PhD, Angers University Hospital
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 (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
Other Study ID Numbers
- 2009-A00533-54
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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