Gait and Alzheimer Interaction Tracking (GAIT) Study (GAIT)

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ClinicalTrials.gov Identifier: NCT01315717

Recruitment Status : Completed

First Posted : March 15, 2011

Last Update Posted : September 22, 2016

Sponsor:

Information provided by (Responsible Party):

University Hospital, Angers

Study Description

Brief Summary:

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 or disease
Gait Apraxia Alzheimer Disease Impaired Cognition Cerebral Atrophy

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 Design


Study Type :	Observational
Actual Enrollment :	912 participants
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
Study Start Date :	November 2009
Actual Primary Completion Date :	May 2016
Actual Study Completion Date :	May 2016

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Alzheimer disease

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease Apraxia

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Group 1 Healthy subjects
Group 2 Patients with Mild Cognitive Impairment
Group 3 Patients with Mild AD
Group 4 Patients with Moderate AD

Outcome Measures

Primary Outcome Measures :

Stride-to-stride variability of stride time [ Time Frame: baseline ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	60 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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):

Graffe A, Beauchet O, Fantino B, Milea D, Annweiler C. Vitamin D and macular thickness in the elderly: an optical coherence tomography study. Invest Ophthalmol Vis Sci. 2014 Jul 15;55(8):5298-303. doi: 10.1167/iovs.14-13918.


Responsible Party:	University Hospital, Angers
ClinicalTrials.gov Identifier:	NCT01315717 History of Changes
Other Study ID Numbers:	2009-A00533-54
First Posted:	March 15, 2011 Key Record Dates
Last Update Posted:	September 22, 2016
Last Verified:	March 2011

Additional relevant MeSH terms:


Apraxias Gait Apraxia Alzheimer Disease Atrophy Cognitive Dysfunction 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 Cognition Disorders Gait Disorders, Neurologic

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