Inappropriate Medications Associated With Anticholinesterase and/or Memantine Treatment in the Elderly (MIDA)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University Hospital, Limoges.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital, Limoges
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00954616
First received: July 31, 2009
Last updated: August 5, 2009
Last verified: August 2009
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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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 700 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | January 2011 |
| Primary Completion Date: | February 2009 (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
Contacts
| Contact: Marie - Laure LAROCHE, Doctor | 0555056743 | marie-laure.laroche@chu-limoges.fr |
Locations
| France | |
| CHU Rouen | Recruiting |
| Rouen, Bois guillaume, France, 76 230 | |
| Contact: Jean DOUCET, Porfessor 02 32 88 90 42 | |
| Principal Investigator: Jean DOUCET, Professor | |
| CHU Bordeaux | Recruiting |
| Pessac, Bordeaux, France, 33 604 | |
| Contact: Muriel RAINFRAY, Professor | |
| Principal Investigator: Muriel RAINFRAY, Professor | |
| CH Le Mans | Recruiting |
| Le Mans, Le Mans Cedex 1, France, 72 037 | |
| Contact: Emmanuel ALIX, Doctor | |
| Principal Investigator: Emmanuel ALIX, Doctor | |
| CHU Montpellier | Recruiting |
| Montpellier, Montpellier Cedex 5, France, 34 295 | |
| Contact: Claude JEANDEL, Professor 04 67 33 96 01 | |
| Principal Investigator: Claude JEANDEL, Professor | |
| APHP Charles Foix | Recruiting |
| Ivry sur Seine, Paris, France, 94 205 | |
| Contact: Aurora LALHOU, Doctor | |
| Principal Investigator: Aurora LALHOU, Doctor | |
| CHU Saint Etienne | Recruiting |
| Saint Etienne, France, 42 055 | |
| Contact: Catherine TERRAT, Doctor | |
| Principal Investigator: Catherine TERRAT, Doctor | |
Sponsors and Collaborators
University Hospital, Limoges
More Information
No publications provided
| Responsible Party: | Marie Sengelen / Directrice de la Recherche clinique et de l'Innovation, CHU Limoges |
| ClinicalTrials.gov Identifier: | NCT00954616 History of Changes |
| Other Study ID Numbers: | I07033 |
| Study First Received: | July 31, 2009 |
| Last Updated: | August 5, 2009 |
| 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 May 23, 2013