Clinical trial NCT01315704: Alzheimer's Disease and Related Disorders
Official title: Maladie d'Alzheimer et Maladies apparentées : Caractérisation Des Anomalies Cognitivo-motrices, et Des Effets Des médicaments Anti-démence et de la Vitamine D à Partir de la Mise en Place d'Une Base de données au CMRR du CHU d'Angers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer's Disease
Gait Apraxia
Impaired Cognition
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2011-03-15
Enrollment: 700
Sex: ALL
Standard ages: CHILD
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 University Hospital with respect to the eligibility criteria

Brief summary: The purpose of this study is to compare characteristics of gait and balance measured among patients with Alzheimer's disease or related disorders separated into 3 groups according to the stage of disease (i.e., pre-dementia, mild and moderate dementia stages); to determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities; and to establish a database at Angers University Memory Centre.

Detailed description: Although gait disorders are frequently associated with Alzheimer's disease and related disorders (ADRD), few studies have focused on cognitive motor effects of anti-dementia drugs and vitamin D.

The objectives of this study are to

* Compare characteristics of gait and balance measured among patients with ADRD separated into 3 groups according to stages of disease (i.e., pre-dementia, mild and moderate dementia stages)
* To determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities
* To determine whether motor abnormalities could be associated with cognitive impairments, specifically executive dysfunctions
* To establish a database at Angers University Memory Center.

Eligibility criteria: Inclusion Criteria:

* All elderly patients from the University Memory Center of Angers University Hospital.
* Able to walk without any walking aid on 15 meters
* Mini-Mental Status Examination score \> 10
* Being affiliated to a social security regime

Exclusion Criteria:

* Mini-Mental Status Examination score ≤ 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
* Use of walking aid such as walking frame with wheels or tricycle.
* Acute medical or surgical disease in the past 3 months
* Refusal to participate (or trustworthy person)
* Near visual acuity \< 2/10

Primary outcomes:
measure: Spatiotemporal gait parameters
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Cédric ANNWEILER , MD
Study officials:
affiliation: Memory Centre of Angers University Hospital
name: Cedric ANNWEILER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beauchet O, Barden J, Liu-Ambrose T, Chester VL, Annweiler C, Szturm T, Grenier S, Leonard G, Bherer L, Allali G; Canadian Gait Consortium. Anti-Dementia Drugs, Gait Performance and Mental Imagery of Gait: A Non-Randomized Open-Label Trial. Drugs Aging. 2016 Sep;33(9):665-73. doi: 10.1007/s40266-016-0391-0.
citation: Beauchet O, Launay CP, Allali G, Watfa G, Gallouj K, Herrmann FR, Annweiler C. Anti-dementia drugs and changes in gait: a pre-post quasi-experimental pilot study. BMC Neurol. 2013 Nov 21;13:184. doi: 10.1186/1471-2377-13-184.