Clinical trial NCT01315717: Gait and Alzheimer Interaction Tracking (GAIT) Study
Official title: Maladie d'Alzheimer et Troubles Locomoteurs : Caracterisation Des Anomalies Temporelles de la Marche et Etude Des Correlats Anatomo-cognitifs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gait Apraxia
Alzheimer Disease
Impaired Cognition
Cerebral Atrophy
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2011-03-15
Enrollment: 912
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients of the University Memory Center of Angers Hospital with respect to the eligibility criteria.

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).

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)

Primary outcomes:
measure: Stride-to-stride variability of stride time
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
Study officials:
affiliation: Angers University Hospital
name: Olivier Beauchet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.