Capacity Assessment in Persons With Alzheimer's Disease (MACAP)
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| First Received Date ICMJE | August 27, 2010 | ||||
| Last Updated Date | July 25, 2012 | ||||
| Start Date ICMJE | June 2010 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01190800 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Capacity Assessment in Persons With Alzheimer's Disease | ||||
| Official Title ICMJE | Decision Capacity Assessment in Persons With Alzheimer's Disease: Approach by Capacity to Appoint a Proxy, to Consent to Treatment and to Vote | ||||
| 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. |
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| 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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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Ecologic or Community Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: None Retained Description: None Retained |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | persons with Alzheimer's disease |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 400 | ||||
| Estimated Completion Date | March 2013 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01190800 | ||||
| Other Study ID Numbers ICMJE | NI 08009 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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