Memory Aid for Informed Consent in Alzheimer's Research - Full Text View

Purpose

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.

Condition	Intervention
Alzheimer's Disease Aging	Device: Memory and Organizational Aid Behavioral: Standard Informed Consent Process

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study
Official Title:	Improving Informed Consent in Alzheimer's Disease Research

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Memory

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

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

Secondary Outcome Measures:

Participant competency

Estimated Enrollment:	110
Study Start Date:	September 2004
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105612

Locations

United States, Pennsylvania
University of Pennsylvania, Memory Disorders Clinic
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Jason Karlawish, MD

University of Pennsylvania Institute on Aging

More Information

Publications:

Marson DC, Ingram KK, Cody HA, Harrell LE. Assessing the competency of patients with Alzheimer's disease under different legal standards. A prototype instrument. Arch Neurol. 1995 Oct;52(10):949-54.

Kim SY, Caine ED, Currier GW, Leibovici A, Ryan JM. Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research. Am J Psychiatry. 2001 May;158(5):712-7.

Sachs GA, Stocking CB, Stern R, Cox DM, Hougham G, Sachs RS. Ethical aspects of dementia research: informed consent and proxy consent. Clin Res. 1994 Oct;42(3):403-12. No abstract available.

Karlawish JH, Casarett DJ, James BD. Alzheimer's disease patients' and caregivers' capacity, competency, and reasons to enroll in an early-phase Alzheimer's disease clinical trial. J Am Geriatr Soc. 2002 Dec;50(12):2019-24.

Appelbaum PS, Grisso T. The MacArthur Competence Assessment Tool - Clinical Research. Sarasota, FL: Professional Resources Press, 2000.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rubright J, Sankar P, Casarett DJ, Gur R, Xie SX, Karlawish J. A memory and organizational aid improves Alzheimer disease research consent capacity: results of a randomized, controlled trial. Am J Geriatr Psychiatry. 2010 Dec;18(12):1124-32.

ClinicalTrials.gov Identifier:	NCT00105612 History of Changes
Other Study ID Numbers:	IA0070, 1R01AG020627-01A2
Study First Received:	March 15, 2005
Last Updated:	December 23, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Informed Consent
Memory Aid

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013