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

Alzheimer's Disease Clinical Trial

— MIDA  

Official title:

Inappropriate Medications and Alzheimer Disease: Prevalence and Associated Factors in Elderly Patients Treated With Anticholinesterase and/or Memantine. MIDA Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00954616
• Other study ID #: I07033
• Status: Completed
• Phase: N/A
• First received: July 31, 2009
• Last updated: March 19, 2014
• Start date: January 2009
• Est. completion date: January 2012

Study information

• Verified date: August 2009
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 636
• Est. completion date: January 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Locations

Country	Name	City	State
France	APHP Charles Foix	Ivry sur Seine	Paris
France	CH Le Mans	Le Mans	Le Mans Cedex 1
France	CHU Montpellier	Montpellier	Montpellier Cedex 5
France	CHU Bordeaux	Pessac	Bordeaux
France	CHU Rouen	Rouen	Bois guillaume
France	CHU Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the prevalence of PIM use in patients aged 75 years and over treated with anticholinesterase and/or memantine		2 years	No
Secondary	To identify factors associated with PIM use. To study the relationship between PIM exposure and adverse effects occurrence.		2 years	No