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Alzheimer's Disease and Related Disorders (MERE)

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose
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 Intervention
Alzheimer's Disease
Gait Apraxia
Impaired Cognition
 Drug: Drug intervention

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • Spatiotemporal gait parameters [ Time Frame: baseline ] [ Designated as safety issue: No ]
Estimated Enrollment: 700
Study Start Date: November 2009
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: March 11, 2011
Last Updated: March 14, 2011
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Apraxias
Gait Apraxia
Alzheimer Disease
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
Gait Disorders, Neurologic
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 30, 2016