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Completed

NCT Number: NCT00105612

Memory Aid for Informed Consent in Alzheimer's 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.

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Key information

Conditions

Alzheimer's Disease Aging Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania, Memory Disorders Clinic

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Memory and Organizational Aid

Device

Standard Informed Consent Process

Behavioral

The informed consent protocol for a hypothetical early-phase drug trial will be administered by a trained interviewer in the patient's home

Primary outcomes

  1. MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) to quantify decision making abilities

Secondary outcomes

  1. Participant competency

Sponsors and collaborators

Lead sponsor

National Institute on Aging (NIA)

Nih

Registry information

Official study title

Improving Informed Consent in Alzheimer's Disease Research

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Mar 16, 2005
Registry last updated
Dec 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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