Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Gait and Alzheimer Interaction Tracking (GAIT) Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University Hospital, Angers.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01315717
First received: March 10, 2011
Last updated: March 14, 2011
Last verified: March 2011
History of Changes
  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:

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 ]
Estimated Enrollment: 600
Study Start Date: November 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (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
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
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

Locations
France
Angers University Hospital Recruiting
Angers, France, 49933
Contact: BEAUCHET Olivier, MD,PhD    (+33)241354725    olbeauchet@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Olivier Beauchet, MD, PhD Angers University Hospital
  More Information

No publications provided

Responsible Party: Director, 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: March 14, 2011
Health Authority: France: Ministry of Health

ClinicalTrials.gov processed this record on March 03, 2015