Gait and Alzheimer Interaction Tracking (GAIT) Study

NCT ID: NCT01315717

Last Updated: 2016-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

912 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2016-05-31

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Gait Apraxia Alzheimer Disease Impaired Cognition Cerebral Atrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1

Healthy subjects

No interventions assigned to this group

Group 2

Patients with Mild Cognitive Impairment

No interventions assigned to this group

Group 3

Patients with Mild AD

No interventions assigned to this group

Group 4

Patients with Moderate AD

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Beauchet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Angers University Hospital

Locations

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Angers University Hospital

Angers, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 25028353 (View on PubMed)

Other Identifiers

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2009-A00533-54

Identifier Type: -

Identifier Source: org_study_id

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