Alzheimer's Disease and Related Disorders (MERE)

This study is currently recruiting participants.

Verified March 2011 by University Hospital, Angers

Sponsor:

Information provided by:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT01315704

First received: March 11, 2011

Last updated: March 14, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 11, 2011

Last Updated Date

March 14, 2011

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

November 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Spatiotemporal gait parameters [ Time Frame: baseline ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01315704 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Alzheimer's Disease and Related Disorders

Official Title ^ICMJE

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

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

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

Condition ^ICMJE

Alzheimer's Disease
Gait Apraxia
Impaired Cognition

Intervention ^ICMJE

Drug: Drug intervention

before-after interventional (anti-dementia drugs and/or vitamin D) study

Other Name: Anti-dementia drugs and/or vitamin D

Study Group/Cohort (s)

Group 1
Patients with Mild Cognitive Impairment

Intervention: Drug: Drug intervention
Group 2
Patients with Mild Alzheimer's disease or related disorders

Intervention: Drug: Drug intervention
Group 3
Patients with Moderate Alzheimer's disease or related disorders

Intervention: Drug: Drug intervention

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

700

Estimated Completion Date

November 2017

Estimated Primary Completion Date

November 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Cedric ANNWEILER, DM

(+33) 241354725

ceannweiler@chu-angers.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01315704

Other Study ID Numbers ^ICMJE

2009-15

Has Data Monitoring Committee

Responsible Party

Cédric ANNWEILER ; MD, Memory Centre of Angers University Hospital

Study Sponsor ^ICMJE

University Hospital, Angers

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Cedric ANNWEILER, MD

Memory Centre of Angers University Hospital

Information Provided By

University Hospital, Angers

Verification Date

March 2011

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

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