An interventional study of Memory and Organizational Aid and Standard Informed Consent Process in Alzheimer's Disease and Aging, sponsored by National Institute on Aging (NIA). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2009-12-29.
Sponsored by National Institute on Aging (NIA) · Not applicable and Interventional
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 110 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →National Institute on Aging (NIA) is the lead sponsor of 157 studies on the registry; 13 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
The informed consent protocol for a hypothetical early-phase drug trial will be administered by a trained interviewer in the patient's home
MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) to quantify decision making abilities
Participant competency
This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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National Institute on Aging (NIA)