Aging Clinical Trial
Official title:
Improving Informed Consent in Alzheimer's Disease Research
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study
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