Memory Aid for Informed Consent in Alzheimer's Research

Not Applicable

Completed

• Conditions: Alzheimer's Disease; Aging

• Registration Number: NCT00105612
• Lead Sponsor: National Institute on Aging (NIA)

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-03-15
• Study First Submitted QC: 2005-03-15
• Study First Posted: 2005-03-16
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-23
• Last Update Posted: 2009-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) to quantify decision making abilities

Secondary Outcome Measures

Name	Time	Method
Participant competency

Trial Locations

Locations (1)

University of Pennsylvania, Memory Disorders Clinic; 🇺🇸 Philadelphia, Pennsylvania, United States