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

March 10, 2011
March 14, 2011
November 2009
November 2012   (final data collection date for primary outcome measure)
Stride-to-stride variability of stride time [ Time Frame: baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01315717 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Gait and Alzheimer Interaction Tracking (GAIT) Study
Maladie d'Alzheimer et Troubles Locomoteurs : Caracterisation Des Anomalies Temporelles de la Marche et Etude Des Correlats Anatomo-cognitifs

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).

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).

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Probability Sample

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

  • Gait Apraxia
  • Alzheimer Disease
  • Impaired Cognition
  • Cerebral Atrophy
Not Provided
  • Group 1
    Healthy subjects
  • Group 2
    Patients with Mild Cognitive Impairment
  • Group 3
    Patients with Mild AD
  • Group 4
    Patients with Moderate AD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
November 2012
November 2012   (final data collection date for primary outcome measure)

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)
Both
60 Years and older
Yes
France
 
NCT01315717
2009-A00533-54
Yes
Director, University Hospital, Angers
University Hospital, Angers
Not Provided
Principal Investigator: Olivier Beauchet, MD, PhD Angers University Hospital
University Hospital, Angers
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP