Parkinson's Disease Biomarker Program (PDBP)
The primary objective of this study is to obtain detailed clinical information and biologic specimens from subjects with PD toward the ultimate end of identifying a biomarker of PD. Because of the inherent difficulties of using clinical outcome measures to assess disease modification, the identification of biomarkers of PD is of paramount importance. The ideal PD biomarker would be one that is easily assayed in a convenient biological sample, varies proportionally with disease severity, is abnormal during the pre-symptomatic phase of the illness, and is unaffected by drugs or other interventions used to treat PD. The existence of a sensitive biomarker with these properties would enable much more effective disease modifying research that would likely be able to take advantage of smaller and potentially shorter trials.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Longitudinal, Single-center Prospective Study to Assess Progression of Clinical Features and Biologic Markers of Parkinson's Disease Subjects of Varying Levels of Disease Severity|
- To estimate the mean rates of change and the variability around the mean of clinical outcomes in PD patients over 3-5 years of follow-up comparing these rates between PD patients of each stage of the Hoehn and Yahr. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- To determine the predictive value of iTUG/iSWAY test results on future course of the disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood specimen collection from all enrolled patients and cerebrospinal fluid (CSF) from patients who have provided additional and optional consent to CSF collection.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||September 2019|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Previously treated PD patients
220 subjects with PD treated and responsive to dopaminergic medication
Previously untreated PD
20 subjects with de-novo, previously untreated PD confirmed by I-123 Ioflupane SPECT
Subjects will be asked to attend study visits every 6 months for up to 5 years of follow up. Each visit will consist of patient outcomes questionnaires, neurological exams, computerized assessments of gait and balance, a video recorded motor exam, and biological specimen collection for biomarker discovery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767818
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Richard Dewey, MD||UT Southwestern Medical Center|