Memory Aid for Informed Consent in Alzheimer's Research
NCT ID: NCT00105612
Last Updated: 2009-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2004-09-30
2007-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
Interventions
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Memory and Organizational Aid
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
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Principal Investigators
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Jason Karlawish, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania Institute on Aging
Locations
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University of Pennsylvania, Memory Disorders Clinic
Philadelphia, Pennsylvania, United States
Countries
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References
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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. doi: 10.1001/archneur.1995.00540340029010.
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. doi: 10.1176/appi.ajp.158.5.712.
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. doi: 10.1046/j.1532-5415.2002.50615.x.
Appelbaum PS, Grisso T. The MacArthur Competence Assessment Tool - Clinical Research. Sarasota, FL: Professional Resources Press, 2000.
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. doi: 10.1097/JGP.0b013e3181dd1c3b.
Other Identifiers
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IA0070
Identifier Type: -
Identifier Source: org_study_id