Capacity Assessment in Persons With Alzheimer's Disease

NCT ID: NCT01190800

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2014-09-30

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine Bosquet, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Louis Mourier

Colombes, , France

Countries

France

Other Identifiers

NI 08009

Identifier Type: -

Identifier Source: org_study_id