Expired Study
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Philadelphia, Pennsylvania 19104


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.


Study summary:

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.


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


NCT ID:

NCT00105612


Primary Contact:

Principal Investigator
Jason Karlawish, MD
University of Pennsylvania Institute on Aging


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

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