Inappropriate Medications Associated With Anticholinesterase and/or Memantine Treatment in the Elderly (MIDA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00954616
First received: July 31, 2009
Last updated: March 19, 2014
Last verified: August 2009
  Purpose

In each of the 7 French areas that should be involved, patients aged 75 years and over from three different sectors will be included: the geriatric consultation unit (60%) and two kinds of nursing homes, private (20%) and state (10%). Outpatients will be included in chronological order; patients in nursing homes will be included at random. The patients and their families will be asked about the treatments received on the day of inclusion. The inclusion period will extend over a year. The investigating practitioners will be asked to fill in a questionnaire reporting the main clinical data, adverse effects occurrence, and information on the treatment given.


Condition
Alzheimer's Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Inappropriate Medications and Alzheimer Disease: Prevalence and Associated Factors in Elderly Patients Treated With Anticholinesterase and/or Memantine. MIDA Study.

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • To evaluate the prevalence of PIM use in patients aged 75 years and over treated with anticholinesterase and/or memantine [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To identify factors associated with PIM use. To study the relationship between PIM exposure and adverse effects occurrence. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 636
Study Start Date: January 2009
Study Completion Date: January 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patient of 75 and more years old affected by the Alzheimer's disease

Criteria

Inclusion Criteria:

  • Patients aged 75 years and over identified as having Alzheimer disease and who have been treated for more than 3 months with anticholinesterase and/or memantine

Exclusion Criteria:

  • Patients with decompensated chronic condition or acute phase disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954616

Locations
France
CHU Rouen
Rouen, Bois guillaume, France, 76 230
CHU Bordeaux
Pessac, Bordeaux, France, 33 604
CH Le Mans
Le Mans, Le Mans Cedex 1, France, 72 037
CHU Montpellier
Montpellier, Montpellier Cedex 5, France, 34 295
APHP Charles Foix
Ivry sur Seine, Paris, France, 94 205
CHU Saint Etienne
Saint Etienne, France, 42 055
Sponsors and Collaborators
University Hospital, Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00954616     History of Changes
Other Study ID Numbers: I07033
Study First Received: July 31, 2009
Last Updated: March 19, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
Inappropriate Medications Associated
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Memantine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Dopamine Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014