Capacity Assessment in Persons With Alzheimer's Disease

Alzheimer's Disease Clinical Trial

— MACAP  

Official title:

Decision Capacity Assessment in Persons With Alzheimer's Disease: Approach by Capacity to Appoint a Proxy, to Consent to Treatment and to Vote

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190800
• Other study ID #: NI 08009
• Status: Completed
• Phase: N/A
• First received: August 27, 2010
• Last updated: October 13, 2014
• Start date: June 2010
• Est. completion date: September 2014

Study information

• Verified date: June 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess decision-making capacity in persons with Alzheimer's disease. First, our goal is to validate four French capacity assessment tools for persons with Alzheimer's Disease : a French version of the Competency Assessment Tool for Consent to Treatment and of the Competency Assessment Tool for Voting, two questionnaires assessing the capacity to appoint a proxy either to consent to treatment or to vote. Second, once validated, we plan these questionnaires to study decision-making abilities and their determinants in persons with Alzheimer's disease and control subjects.

Description:

Study of Alzheimer's disease patients show a wide variability in decision-making abilities, especially for the consent to treatment and the ability to vote. No tools are available to assess the capacity to design a proxy. The purpose of this research is to assess simultaneously four decision-making abilities in persons with Alzheimer's disease: the capacity to consent to treatment, the capacity to vote and the capacity to design a proxy either to consent to treatment or to vote.

This study will recruit 320 patients with Alzheimer's disease and 80 non-demented control subjects. Four decision-making questionnaires will be administered to participants to explore participant capacity to understand, reason, appreciate and make a choice about the capacity to consent to treatment, to vote and to design a proxy either to consent to treatment or to vote. Once validated in the first part of this research, the questionnaires will be used to study decision-making abilities and their determinants in patients with Alzheimer's disease and control subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• for patients with Alzheimer's disease: age >=18 years, to be native speakers of French and French nationality, Diagnosed with a Alzheimer's disease and followed in a French "Centre Memory of Resources and Research"(CMRR)

• for control subjects: age >=18 years, to be native speakers of French and French nationality, have no complaints of memory problems, primary caregiver of patient with AD of the same age as the patient nearly 10 years

Exclusion Criteria:

• for all participants: confusion, severe psychiatric disorders, stroke, blindness, uncorrected hearing loss, refusal to participate in the study

• for patients with Alzheimer's disease: other dementia than AD

• for control subjects: diagnosed dementia

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Capacity to Consent to Treatment
• Capacity to Design a Proxy
• Capacity to Vote

Locations

Country	Name	City	State
France	Hôpital Louis Mourier	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France,