Gait and Alzheimer Interaction Tracking (GAIT) Study (GAIT)
This study has been completed.
Sponsor:
University Hospital, Angers
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01315717
First received: March 10, 2011
Last updated: September 21, 2016
Last verified: March 2011
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Purpose
The purpose 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).
| Condition |
|---|
|
Gait Apraxia Alzheimer Disease Impaired Cognition Cerebral Atrophy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Maladie d'Alzheimer et Troubles Locomoteurs : Caracterisation Des Anomalies Temporelles de la Marche et Etude Des Correlats Anatomo-cognitifs |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Walking Problems
U.S. FDA Resources
Further study details as provided by University Hospital, Angers:
Primary Outcome Measures:
- Stride-to-stride variability of stride time [ Time Frame: baseline ] [ Designated as safety issue: No ]
| Enrollment: | 912 |
| Study Start Date: | November 2009 |
| Study Completion Date: | May 2016 |
| Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Group 1
Healthy subjects
|
|
Group 2
Patients with Mild Cognitive Impairment
|
|
Group 3
Patients with Mild AD
|
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Group 4
Patients with Moderate AD
|
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).
Eligibility| Ages Eligible for Study: | 60 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
All patients of the University Memory Center of Angers Hospital with respect to the eligibility criteria.
Criteria
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)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315717
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315717
Locations
| France | |
| Angers University Hospital | |
| Angers, France, 49933 | |
Sponsors and Collaborators
University Hospital, Angers
Investigators
| Principal Investigator: | Olivier Beauchet, MD, PhD | Angers University Hospital |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital, Angers |
| ClinicalTrials.gov Identifier: | NCT01315717 History of Changes |
| Other Study ID Numbers: | 2009-A00533-54 |
| Study First Received: | March 10, 2011 |
| Last Updated: | September 21, 2016 |
| Health Authority: | France: Ministry of Health |
Additional relevant MeSH terms:
|
Apraxias Gait Apraxia Alzheimer Disease Atrophy Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies |
Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Pathological Conditions, Anatomical Psychomotor Disorders Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Gait Disorders, Neurologic |
ClinicalTrials.gov processed this record on September 29, 2016