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Memory Aid for Informed Consent in Alzheimer's Research

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00105612
Recruitment Status : Completed
First Posted : March 16, 2005
Last Update Posted : December 29, 2009
Sponsor:
Information provided by:
National Institute on Aging (NIA)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Aging Device: Memory and Organizational Aid Behavioral: Standard Informed Consent Process Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 110 participants
Allocation: Randomized
Official Title: Improving Informed Consent in Alzheimer's Disease Research
Study Start Date : September 2004
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Device: Memory and Organizational Aid
  • 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

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

Secondary Outcome Measures :
  1. Participant competency

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105612


Locations
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United States, Pennsylvania
University of Pennsylvania, Memory Disorders Clinic
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Jason Karlawish, MD University of Pennsylvania Institute on Aging
More Information
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Publications:
Appelbaum PS, Grisso T. The MacArthur Competence Assessment Tool - Clinical Research. Sarasota, FL: Professional Resources Press, 2000.

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

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ClinicalTrials.gov Identifier: NCT00105612    
Other Study ID Numbers: IA0070
1R01AG020627-01A2 ( U.S. NIH Grant/Contract )
First Posted: March 16, 2005    Key Record Dates
Last Update Posted: December 29, 2009
Last Verified: December 2009
Keywords provided by National Institute on Aging (NIA):
Informed Consent
Memory Aid
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders