Alzheimer's Disease and Related Disorders

• Conditions: Alzheimer's Disease; Gait Apraxia; Impaired Cognition
• Interventions: Drug: Drug intervention

• Registration Number: NCT01315704
• Lead Sponsor: University Hospital, Angers

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.

Study Timeline

• Study Start: 2009-11
• Status Verified: 2011-03
• Study First Submitted: 2011-03-11
• Study First Submitted QC: 2011-03-14
• Last Update Submitted: 2011-03-14
• Study First Posted: 2011-03-15
• Last Update Posted: 2011-03-15
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Drug intervention	Patients with Mild Cognitive Impairment
Group 2	Drug intervention	Patients with Mild Alzheimer's disease or related disorders
Group 3	Drug intervention	Patients with Moderate Alzheimer's disease or related disorders

Primary Outcome Measures

Name	Time	Method
Spatiotemporal gait parameters	baseline

Trial Locations

Locations (1)

Cédric ANNWEILER , MD; 🇫🇷 Angers, France