DATATOP (Deprenyl And Tocopherol Antioxidative Therapy Of Parkinsonism), led by Ira Shoulson, MD, and Stanley Fahn, MD, and sponsored by NINDS, is the largest and longest prospective controlled study of therapeutic interventions in Parkinson's disease conducted in the world. It was the first of PSG's multi-center trials.
The original cohort of 800 subjects in DATATOP represents the largest group of early Parkinson's disease patients to be followed prospectively and systematically. In-person evaluations of this cohort began in 1987. The DATATOP trial was carried out to determine whether long-term therapy with deprenyl (selegiline) and/or tocopherol would extend the time before advancing disability required the initiation of levodopa therapy in patients with early, untreated Parkinson's disease. Deprenyl, 10 mg/day, was found to significantly delay the initiation of levodopa. Tocopherol, 2000 IU/day, produced no benefits and there was no interaction of the two drugs. Serum, urine, CSF, and DNA from the DATATOP Trial are available for research. Below find the following study documents:
1. DATATOP Protocol Synopsis
2. DATATOP Schedule of Activites (SOA)
3. DATATOP Data Dictionary
4. Instructions for downloading data
5. Annotated DATATOP Case Report Forms
6. Links to publications