Memory Aid for Informed Consent in Alzheimer's Research

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Informed Consent in Alzheimer's Disease Research

Conditions
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Alzheimer's Disease, Aging

Intervention / Treatment
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* Device: Memory and Organizational Aid
* Behavioral: Standard Informed Consent Process


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Live within one hour drive of the University of Pennsylvania's Memory Disorders Clinic Education equivalent to 6th grade level Corrected visual acuity of at least 20/70 Speak English Diagnosed with possible or probable AD, or non-demented MMSE (Mini Mental State Exam) >= 18
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Memory and Organizational Aid|nan|
|Behavioral: Standard Informed Consent Process|The informed consent protocol for a hypothetical early-phase drug trial will be administered by a trained interviewer in the patient's home|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) to quantify decision making abilities |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant competency |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Informed Consent, Memory Aid