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Memory Aid for Informed Consent in Alzheimer's Research - Article


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Alzheimer's Disease

AD; Alzheimer disease; Alzheimer//'s disease; Alzheimer///'s disease; DAT - Dementia Alzheimer's type; familial Alzheimer disease (FAD); Presenile and senile dementia; Primary Senile Degenerative Dementia; SDAT


Clinical Trial: Memory Aid for Informed Consent in Alzheimer's Research

This study is currently recruiting patients.

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)

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 Treatment or Intervention
Alzheimer's Disease
Aging
 Device: Memory and Organizational Aid

MedlinePlus related topics:  Alzheimer's Caregivers;   Alzheimer's Disease
Genetics Home Reference related topics:  Alzheimer disease

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Efficacy Study

Official Title: Improving Informed Consent in Alzheimer's Disease Research

Further Study Details: 
Primary Outcomes: MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) to quantify decision making abilities
Expected Total Enrollment:  110

Study start: September 2004;  Expected completion: August 2007

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

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

Location and Contact Information

Jonathan Rubright      215-349-5545    jrubrigh@mail.med.upenn.edu

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

Study chairs or principal investigators

Jason Karlawish, MD,  Principal Investigator,  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.

Study ID Numbers:  IA0070; 1R01AG020627-01A2
Record last reviewed:  March 2005
Last Updated:  March 16, 2005
Record first received:  March 15, 2005
ClinicalTrials.gov Identifier:  NCT00105612
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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