NIC-PD Trial to Assess the Disease-modifying Potential of Transdermal Nicotine in Early Parkinson's Disease

Objective/Rationale:
No drugs are available that can slow or stop the progression of Parkinson’s disease (PD). Nicotine is a promising substance for this purpose. Firstly, epidemiological studies suggest a protective effect of nicotine: PD is much less prevalent among smokers compared to never-smokers. Secondly, in experimental neuroscience, including in pre-clinical models, nicotine has shown beneficial effects. Thirdly, the drug is widely available and exhibits a favorable safety profile.

Project Description:
The NIC-PD trial assesses for the first time the disease-modifying potential of transdermal nicotine (nicotine patches) in patients at very early stages of Parkinson’s disease who do not yet require symptomatic treatment. About 150 PD patients will be enrolled in this multi-center trial. These patients will be randomly assigned to receive either nicotine patches or placebo patches over a treatment period of 12 months in a double-blinded manner. Double-blinded means that neither the patient nor the treating physician know whether the patient receives placebo or the active drug (nicotine). The effect of nicotine will be assessed by standardized clinical rating scales (UPDRS). If required by the patient, symptomatic therapy is allowed.

Relevance to Diagnosis/Treatment of Parkinson’s Disease: 
The disease-modifying potential of nicotine is of great value, as this approach could easily be translated in routine care due to the wide availability and safety of the investigated substance.

Anticipated Outcome:
This study will show whether nicotine can slow disease progression in Parkinson’s disease. If effective, nicotine could serve as a model substance for disease modification in other neurodegenerative disorders. Also of note, NIC-PD is the first investigator-initiated, transatlantic collaboration between PD networks in Germany and the United States.