Memory Aid for Informed Consent in Alzheimer's Research

Aging Clinical Trial

Official title:

Improving Informed Consent in Alzheimer's Disease Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105612
• Other study ID #: IA0070
• Secondary ID: 1R01AG020627-01A
• Status: Completed
• Phase: N/A
• First received: March 15, 2005
• Last updated: December 23, 2009
• Start date: September 2004
• Est. completion date: March 2007

Study information

• Verified date: December 2009
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study

Related Conditions & MeSH terms

• Aging
• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
United States	University of Pennsylvania, Memory Disorders Clinic	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) to quantify decision making abilities
Secondary	Participant competency