Gait and Alzheimer Interaction Tracking (GAIT) Study | NCT01315717

Studies
Gait and Alzheimer Interaction Tracking (GAIT) Study

NCT01315717

Sponsor

University Hospital, Angers

Status

Completed

Last Update Posted

Sep 22, 2016Estimated

Enrollment

912Actual

Phase

Not provided

Conditions

Gait Apraxia
Alzheimer Disease
Impaired Cognition
Cerebral Atrophy

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Mar 10, 2011

First Submission Date that Met QC Criteria

Mar 14, 2011

First Posted Date

Mar 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2016

Last Update Posted Date

Sep 22, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

912Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Healthy subjects
Group 2		Patients with Mild Cognitive Impairment
Group 3		Patients with Mild AD
Group 4		Patients with Moderate AD

Interventions

Not provided

Measure	Description	Time Frame
Stride-to-stride variability of stride time		baseline

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients of the University Memory Center of Angers Hospital with respect to the eligibility criteria.

Sampling Method

Probability Sample

Name	Affiliation	Role
Olivier Beauchet, MD, PhD	University Hospital, Angers	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Angers University Hospital		Angers		49933	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25028353	Derived	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.

ID	Term
D020235	Gait Apraxia
D000544	Alzheimer Disease
D003072	Cognition Disorders

ID	Term
D020233	Gait Disorders, Neurologic
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D001072	Apraxias