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The National Institutes of Health Exploratory Trials in Parkinson Disease (NET-PD) Experience

Sotirios A. Parashos, MD, PhD; Christopher J. Swearingen, MS; Kevin M. Biglan, MD, MPH; Ivan Bodis-Wollner, MD, DSc; Grace S. Liang, MD; G. Webster Ross, MD; Barbara C. Tilley, PhD; Lisa M. Shulman, MD; for the NET-PD Investigators

Arch Neurol. 2009;66(9):1099-1104. Published online July 13, 2009 (doi:10.1001/archneurol.2009.159).

Objective  To assess the predictive value of baseline measures of impairment, disability, and quality of life for the timing of initiation of symptomatic treatment in early Parkinson disease (PD).

Design  Inception cohort analysis.

Setting  Ambulatory population from multiple sites in the United States and Canada.

Participants  Four hundred thirteen patients with early, untreated PD who participated in 2 double-blind trials that assessed the potential of experimental drugs to serve as disease-modifying agents in PD.

Intervention  Participants were randomized into treatment groups: creatine (n = 67), minocycline (n = 66), coenzyme Q10 (n = 71), GPI-1485 (n = 71), and placebo (n = 138).

Main Outcome Measure  Time between baseline assessment and need for the initiation of symptomatic treatment for PD. The following baseline variables were assessed for their relation to the main outcome measure, while adjusting for possible treatment effect: sex; age; level of education; race/ethnicity; disease duration; occupational status; and Unified Parkinson Disease Rating Scale (UPDRS), Medical Outcomes Study Short Form Survey, Modified Rankin Scale, Schwab and England Activities of Daily Living Scale, Total Functional Capacity Scale, 39-item Parkinson Disease Questionnaire, and Geriatric Depression Scale scores. Variables reaching statistical threshold in univariate analyses ( = .15) were entered into a multivariable Cox proportional hazards regression model using time to symptomatic treatment as the dependent variable.

Results  Approximately half (48.5%) of the participants reached end point within 12 months. Higher baseline impairment and disability, as determined by UPDRS III (motor section), UPDRS II (activities of daily living section, participant rating), and Modified Rankin Scale scores and level of education were independently associated with an earlier need for symptomatic treatment.

Conclusions  In early PD, greater impairment and disability and higher level of education are independently associated with an earlier need for symptomatic treatment.

Author Affiliations: Struthers Parkinson's Center, Golden Valley, Minnesota (Dr Parashos); Department of Biostatistics, Bioinformatics, and Epidemiology, Medical University of South Carolina, Charleston (Mr Swearingen and Dr Tilley); Department of Neurology, University of Rochester, Rochester, New York (Dr Biglan); State University of New York, Downstate Medical Center, Brooklyn (Dr Bodis-Wollner); The Parkinson's Institute and Clinical Center, Sunnyvale, California (Dr Liang); Pacific Health Research Institute, Honolulu, Hawaii (Dr Ross); and Department of Neurology, University of Maryland School of Medicine, Baltimore (Dr Shulman).
Group Information: A list of the NET-PD Investigators was published in Neurology. 2006;66(5):664-671; and Neurology. 2007;68(1):20-28.

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