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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00105612 |
The purpose of this trial is to test whether a memory and organizational aid in the form of a document that summarizes and simplifies a study's key points can improve the decision-making abilities and competency of mild to early moderate Alzheimer's disease (AD) patients.
Condition | Intervention |
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Alzheimer's Disease Aging |
Device: Memory and Organizational Aid Behavioral: Standard Informed Consent Process |
Study Type: | Interventional |
Study Design: | Randomized, Efficacy Study |
Official Title: | Improving Informed Consent in Alzheimer's Disease Research |
Estimated Enrollment: | 110 |
Study Start Date: | September 2004 |
Study Completion Date: | March 2007 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Studies of mild to moderate Alzheimer's disease (AD) patients reveal substantial variation in their ability to participate in an informed consent process. No published data show techniques that help an AD patient to participate in an informed consent. This research will address this issue by performing a randomized trial to test whether a memory and organizational aid can improve the decision-making abilities and competency of AD patients.
This study will recruit 80 patients with mild to early moderate AD, and 30 non-demented elderly persons. The informed consent protocol for a hypothetical early-phase drug trial will be administered by a trained interviewer in the patient's home. The AD patients will be randomized to receive either the standard informed consent process or the intervention of the standard informed consent process plus the memory and organizational aid. All non-demented elderly individuals will receive the standard informed consent process. The interviewer will administer the protocol to participants and ask questions that will assess participant capacity to understand, appreciate, reason, and make a choice concerning enrollment in the hypothetical study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, Pennsylvania | |
University of Pennsylvania, Memory Disorders Clinic | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Jason Karlawish, MD | University of Pennsylvania Institute on Aging |
Study ID Numbers: | IA0070, 1R01AG020627-01A2 |
Study First Received: | March 15, 2005 |
Last Updated: | June 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00105612 |
Health Authority: | United States: Federal Government |
Informed Consent Memory Aid |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |