NCT00105612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

December 29, 2009

Status Verified

December 1, 2009

Enrollment Period

2.5 years

First QC Date

March 15, 2005

Last Update Submit

December 23, 2009

Conditions

Alzheimer's DiseaseAging

Keywords

Informed ConsentMemory Aid

Outcome Measures

Primary Outcomes (1)

  • MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) to quantify decision making abilities

Secondary Outcomes (1)

  • Participant competency

Interventions

Memory and Organizational AidDEVICE
Standard Informed Consent ProcessBEHAVIORAL

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

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania, Memory Disorders Clinic

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (6)

  • 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.

    PMID: 7575221BACKGROUND

  • 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.

    PMID: 11329391BACKGROUND

  • 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.

    PMID: 7955902BACKGROUND

  • 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.

    PMID: 12473015BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 20808101DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Jason Karlawish, MD

    University of Pennsylvania Institute on Aging

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Sponsor Type
NIH

Study Record Dates

First Submitted

March 15, 2005

First Posted

March 16, 2005

Study Start

September 1, 2004

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

December 29, 2009

Record last verified: 2009-12

Locations

US(1)