This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The overall objective of this project is to demonstrate the feasibility of enrolling a cohort of former clinical trial participants into a follow-up observational study that will be used to develop biomarkers and assess the treated natural history of Parkinson's disease (PD). The required aspects of this study are the core data set items. Other activities such as FOUND, and imaging are integrated studies that are encouraged. Specific objectives are to:1) Establish a mechanism for longitudinal follow-up of patients with PD who have participated in the Parkinson Study Group (PSG) PRECEPT study and determine rates of participation and retention for in-person and remote follow-up. Clear milestones will be used to assess the success of these efforts: a) proportion of subjects initially enrolled into the follow-up project from the PRECEPT clinical trial cohort b) annual retention for in-person visits c) annual retention for SPECT imaging d) proportion of subjects providing DNA to NINDS (Coriell) repository e) proportion of subjects participating in remote follow-up through the FOUND study2) Demonstrate the feasibility of this mechanism to evaluate biomarkers and novel clinical signs in cross-sectional and longitudinal studies. This will be done through longitudinal use of beta-CIT SPECT in conjunction with olfactory (smell) testing (UPSIT) to determine the sensitivity and specificity of smell testing for identifying subjects with and without dopaminergic deficiency on SPECT.3) Use this cohort to follow the treated natural history of PD (motor, cognitive and behavioral), to validate measures of cognition, and to develop models and prediction rules for motor and non-motor complications, including: a) administration of the Montreal Cognitive Assessment (MOCA) in conjunction with the NINDS Parkinson's Disease Data and Organizing Center (PD-DOC) core clinical evaluation (R Kurlan, PI) to determine the MOCA's sensitivity to change in PD. b) modeling of onset of motor complications, depression, and rate of cognitive decline in this treated natural history cohort in an attempt to identify specific risk factors.

National Institute of Health (NIH)
National Center for Research Resources (NCRR)
General Clinical Research Centers Program (M01)
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Special Emphasis Panel (ZRR1-CR-1 (01))
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Johns Hopkins University
Internal Medicine/Medicine
Schools of Medicine
United States
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