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CompletedNCT01190800MACAPUpdated Oct 15, 2014

Capacity Assessment in Persons With Alzheimer's Disease

An observational study in Alzheimer's Disease, Capacity to Consent to Treatment and Capacity to Vote, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-15.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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

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Keywords

  • Alzheimer's Disease
  • Capacity assessment
  • Decision-making assessment
  • Capacity to consent to treatment
  • Capacity to vote
  • Capacity to appoint a proxy
03

In context

Alzheimer Disease

3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's planned enrollment of 400 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,504 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

persons with Alzheimer's disease

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

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
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
400 participants (estimated)
Biospecimen retention
None retained
06

Study locations

1 site
  • Hôpital Louis Mourier
    Colombes, 92700, France
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01190800
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Aug 30, 2010
Start date
Jun 2010
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Oct 15, 2014

Study contacts

Antoine Bosquet, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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