Alzheimer's Disease and Related Disorders

Alzheimer's Disease Clinical Trial

— MERE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01315704
• Other study ID #: 2009-15
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2011
• Last updated: March 14, 2011
• Start date: November 2009
• Est. completion date: November 2017

Study information

• Verified date: March 2011
• Source: University Hospital, Angers
• Contact: Cedric ANNWEILER, DM
• Phone: (+33) 241354725
• Email: ceannweiler[@]chu-angers.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Gait Apraxia
• Impaired Cognition

Intervention

Drug:
• Drug intervention
before-after interventional (anti-dementia drugs and/or vitamin D) study

Locations

Country	Name	City	State
France	Cédric ANNWEILER , MD	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spatiotemporal gait parameters		baseline	No