Objective: The primary endpoint of clinical progression is measured by change in the total UPDRS score between baseline and 1) after 52 weeks of study treatment and 2) – after an additional 2 months of treatment washout (60 weeks of study duration).

Background: Numerous epidemiological studies have consistently shown an inverse relation between the susceptibility to Parkinson’s disease (PD) and tobacco consumption: i.e. PD is less prevalent among smokers compared to never-smokers. Nicotine has been shown in vitro to reduce the toxicity related to alpha-synuclein-aggregation, and to up-regulate anti-apoptotic proteins that might slow neurodegeneration in PD. We therefore sought to investigate the potential disease-modifying effect of transdermal nicotine on the progression of early PD in the NIC-PD study.

Methods: 162 early PD subjects within 18 months of diagnosis, with Hoehn and Yahr stage <2 and not expected to require dopamine agonist or levodopa therapy for 1 year and without or with stable (>2 months) MAO-B inhibitor therapy entered the study. Recruitment period was planned to be 18 months with 12 months treatment duration, followed by a washout period of 2 months. The NIC-PD Study Group is a collaboration of the German Parkinson Study Group (GPS) and the Parkinson Study Group (PSG).

Results: A total of 517 de novo PD patients were screened in order to randomize a total of 162 PD patients at 24 centers (60 PD patients in the US at 11 centers and 102 PD patients in Germany at 13 centers). Recruitment period lasted 33 months (October 2012 to March 2014). Baseline demographics were as follows: Mean age 61 (±9.9 years), 66.6% male, 52 % of the patients were in H&Y stage 2, with H&Y stage 1 in 34% and H&Y stage 1.5 in 13%, and half of the patients received an MAO-B-inhibitor.

Conclusions: The cooperation of USA and German sites has successfully recruited the planned number of early PD patients for a study which tests the potential disease-modifying effect of nicotine on the progression of PD. Last patient out of this study will be summer 2016 and first results are expected to be released at the end of 2016. Supported by MJFF, PSG – USA and IPF, DPG, GPS-KNP, Novartis-Pharma – Germany.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/the-nic-pd-study-baseline-data-of-a-randomized-placebo-controlled-double-blind-multi-centre-trial-to-assess-the-disease-modifying-potential-of-transdermal-nicotine-in-early-parkinsons-disea/