Enhancing Consent for Alzheimer's Research
Enhancing Consent for Alzheimer's Research
Overall Status:
No longer recruiting
Brief Description:
The purpose of this study is to evaluate the efficacy of an enhanced consent procedure for patients with mild to moderate Alzheimer disease and to identify factors and patient characteristics that predict the degree to which enhanced consent is more beneficial than routine consent procedures.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
50 Years | N/A | Both | Accepts Healthy Volunteers |
Inclusion Criteria:
- Clinical diagnosis of mild to moderate possible or probable AD or comparable healthy comparison subjects
- Fluency in English
- 50 years and older
- Informed written consent (or written assent with consent from legally authorized representative)
Exclusion Criteria:
- Diagnosis of Lewy body dementia or mild cognitive impairment
- Mini Mental State Exam score of less than 15
- Physical or medical conditions that preclude participants from completing tasks
- Neurologic or psychiatric condition that could impair neurocognitive functioning in healthy volunteers
Detailed Description:
Alzheimer disease can impair the capacity of patients to give informed consent for research participation. Studies of informed consent involving other patient populations suggest better understanding of consent-relevant information may be achieved through modifications in the consent delivery process, including incorporation of multimedia learning tools into the consent discussion.
In the present study, participants with Alzheimer disease and age-comparable healthy participants will be randomly assigned to review a hypothetical research protocol via routine or enhanced consent procedures. Participants will also complete standard cognitive and other rating scales so that we can characterize the sample, as well as evaluate the degree to which specific characteristics may be associated with need for enhanced consent procedures. Advances in the methods to optimize the informed consent process should enable future research participants to make more fully informed decisions.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 32.8758428, -117.2367464 | Veterans Affairs San Diego Healthcare System | San Diego | California | 92161 | Recruiting |
Lead Sponsor:
| Agency |
|---|
National Institute on Aging (NIA) |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Barton W. Palmer, PhD | Principal Investigator | UCSD |
Study Contact:
| Name | Phone | |
|---|---|---|
Tia Thrasher, BA | 858-535-5795 |
Locations
ClinicalTrials.gov ID
NCT00453544 (follow link to view full record on ct.gov in new window)
Official Title:
Enhancing Consent for Alzheimer's Research
Study Start Date:
April 2006
Study End Date:
December 2011
Disease Stage:
Early
Middle
Enrollment:
272
Trial References:
http://www.ncbi.nlm.nih.gov/pubmed/11329391">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.
http://www.ncbi.nlm.nih.gov/pubmed/15494623">Alzheimer's Association. Research consent for cognitively impaired adults: recommendations for institutional review boards and investigators. Alzheimer Dis Assoc Disord. 2004 Jul-Sep;18(3):171-5.
http://www.ncbi.nlm.nih.gov/pubmed/7053558">Kolata G. Alzheimer's research poses dilemma. Science. 1982 Jan 1;215(4528):47-8.
http://www.ncbi.nlm.nih.gov/pubmed/11331139">Dunn LB, Jeste DV. Enhancing informed consent for research and treatment. Neuropsychopharmacology. 2001 Jun;24(6):595-607.
