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Alzheimer's Disease and Related Disorders (MERE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01315704
Recruitment Status : Unknown
Verified March 2011 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : March 15, 2011
Last Update Posted : March 15, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Alzheimer's Disease Gait Apraxia Impaired Cognition Drug: Drug intervention

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 Design

Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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 Start Date : November 2009
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017


Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1
Patients with Mild Cognitive Impairment
Drug: Drug intervention
before-after interventional (anti-dementia drugs and/or vitamin D) study
Other Name: Anti-dementia drugs and/or vitamin D
Group 2
Patients with Mild Alzheimer's disease or related disorders
Drug: Drug intervention
before-after interventional (anti-dementia drugs and/or vitamin D) study
Other Name: Anti-dementia drugs and/or vitamin D
Group 3
Patients with Moderate Alzheimer's disease or related disorders
Drug: Drug intervention
before-after interventional (anti-dementia drugs and/or vitamin D) study
Other Name: Anti-dementia drugs and/or vitamin D


Outcome Measures

Primary Outcome Measures :
  1. Spatiotemporal gait parameters [ Time Frame: baseline ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients of the University Memory Center of Angers University Hospital with respect to the eligibility criteria
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315704


Contacts
Contact: Cedric ANNWEILER, DM (+33) 241354725 ceannweiler@chu-angers.fr

Locations
France
Cédric ANNWEILER , MD Recruiting
Angers, France, 49933
Contact: Cedric ANNWEILER, MD    (+33)241354725    ceannweiler@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Cedric ANNWEILER, MD Memory Centre of Angers University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cédric ANNWEILER ; MD, Memory Centre of Angers University Hospital
ClinicalTrials.gov Identifier: NCT01315704     History of Changes
Other Study ID Numbers: 2009-15
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: March 15, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Alzheimer Disease
Apraxias
Cognitive Dysfunction
Gait Apraxia
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Psychomotor Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Cognition Disorders
Gait Disorders, Neurologic
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents