This program is in collaboration with The Michael J. Fox Foundation to support the identification and validation of novel biomarkers through use of the DATATOP biospecimen and clinical data resource. The DATATOP (Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism) intervention trial, conducted by the PSG in the late 1980s, also collected serum, cerebrospinal fluid, urine and DNA from trial participants to be banked for subsequent analyses. The biologic specimens paired with the clinical data from this study are a unique resource for identifying and verifying objective markers that change with clinical features of Parkinson disease.
Click here to download additional details of the DATATOP trial.
Note: For projects requiring access to the DATATOP biospecimen repository, a separate proposal review and funding mechanism is now managed through NINDS at https://pdbp.ninds.nih.gov/pd-brac.
This was an NINDS funded Phase 3, parallel group, 36 months study evaluating the efficacy of isradipine 10mg daily versus placebo (1:1 randomization, ITT analysis) to slow progression of disability in de novo PD participants. The study was conducted at 54 Parkinson Study Group sites in US and Canada. The study enrolled 336 participants between November 2014 -November 2015, the last participant completed the study November 20, 2018. The study retention rate was 95%. The primary outcome measure was the change from baseline in the Unified Parkinson Disease Rating Scale (UPDRS) Part I-III score measured in the ON state at month 36. Secondary outcomes include change in UPDRS-III in the OFF state, time to initiation and utilization of dopaminergic therapy, time to onset of motor complications, change in non-motor disability and quality of life measures. Isradipine 10 mg daily did not slow progression of disability in early PD. Key secondary outcomes showed no effect of isradipine treatment.