The success of research efforts to guide evidence-based care that is sensitive to the unique needs of Parkinsons disease (PD) patients rests on the effective enrollment of PD patients as research subjects. Yet the very problems caused by PD that warrant research are also the cause of ethical challenges to that research: progressive cognitive impairments. This project will understand the impact of cognitive as well as neuropsychiatric impairments on a patient's ability to make a research enrollment decision. This study will involve in-home, face-to-face interviews with 90 Parkinsons patients and 30 cognitively normal older adults. The interview will gather research consent capacity data using a standardized decisional capacity interview tool as well as cognitive assessments. We will examine the nature of the severity of capacity impairments in persons with Parkinsons disease and the patterns of those impairments to examine how capacity impairments vary as a function of overall cognitive impairment in Parkinsons disease and compare this performance to cognitively intact older adults. We will also examine the clinical significance of Parkinsons patient performance on the measures of the decisional abilities: understanding, appreciation, reasoning and choice. To achieve this, we will have expert raters judge whether the patient has sufficient capacity, which will allow us to examine how well a given ability score classifies a patient as capable of consent and how well measures of the clinical severity of Parkinson's disease associate with the risk of loss of capacity to consent. Finally, we will examine how personality traits affect both the capacity to consent and the decision whether to enroll in early phase research. In sum, the three aims of this project will show clinicians, investigators, patients and families how the cognitive and personality problems seen in persons with Parkinsons disease affect patients'ability to make ethically challenging decisions and the decisions that they make.

Public Health Relevance

The success of research efforts to guide evidence-based care that is sensitive to the unique needs of Parkinsons disease (PD) patients rests on the effective enrollment of PD patients as research subjects. Yet the very problems caused by PD that warrant research are also the cause of ethical challenges to that research: progressive cognitive impairments. This project will understand the impact of cognitive as well as neuropsychiatric impairments on a patient's ability to make a research enrollment decision.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project (R01)
Project #
1R01NS065087-01A1
Application #
7783346
Study Section
Special Emphasis Panel (ZRG1-HDM-D (90))
Program Officer
Galpern, Wendy R
Project Start
2009-09-20
Project End
2012-08-31
Budget Start
2009-09-20
Budget End
2010-08-31
Support Year
1
Fiscal Year
2009
Total Cost
$253,640
Indirect Cost
Name
University of Pennsylvania
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Brennan, Laura; Devlin, Kathryn M; Xie, Sharon X et al. (2017) Neuropsychological Subgroups in Non-Demented Parkinson's Disease: A Latent Class Analysis. J Parkinsons Dis 7:385-395
Brennan, Laura; Siderowf, Andrew; Rubright, Jonathan D et al. (2016) The Penn Parkinson's Daily Activities Questionnaire-15: Psychometric properties of a brief assessment of cognitive instrumental activities of daily living in Parkinson's disease. Parkinsonism Relat Disord 25:21-6
Moelter, Stephen T; Weintraub, Daniel; Mace, Lauren et al. (2016) Research consent capacity varies with executive function and memory in Parkinson's disease. Mov Disord 31:414-7
Skogseth, Ragnhild E; Bronnick, Kolbjorn; Pereira, Joana B et al. (2015) Associations between Cerebrospinal Fluid Biomarkers and Cognition in Early Untreated Parkinson's Disease. J Parkinsons Dis 5:783-92
Pereira, Joana B; Svenningsson, Per; Weintraub, Daniel et al. (2014) Initial cognitive decline is associated with cortical thinning in early Parkinson disease. Neurology 82:2017-25
Karlawish, Jason; Cary, Mark; Moelter, Stephen T et al. (2013) Cognitive impairment and PD patients' capacity to consent to research. Neurology 81:801-7
Hu, W T; Chen-Plotkin, A; Grossman, M et al. (2010) Novel CSF biomarkers for frontotemporal lobar degenerations. Neurology 75:2079-86
Siderowf, A; Xie, S X; Hurtig, H et al. (2010) CSF amyloid {beta} 1-42 predicts cognitive decline in Parkinson disease. Neurology 75:1055-61
Rubright, Jonathan; Sankar, Pamela; Casarett, David J et al. (2010) A memory and organizational aid improves Alzheimer disease research consent capacity: results of a randomized, controlled trial. Am J Geriatr Psychiatry 18:1124-32
Karlawish, Jason; Rubright, Jonathan; Casarett, David et al. (2009) Older adults' attitudes toward enrollment of non-competent subjects participating in Alzheimer's research. Am J Psychiatry 166:182-8