NIC-PD
Trial question
What is the role of transdermal nicotine treatment in patients with early Parkinson's disease?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 162
162 patients (51 female, 111 male).
Inclusion criteria: patients with Parkinson's disease, diagnosed within 18 months, who were in Hoehn and Yahr disease stage ≤ 2, who were therapy-naïve, and not requiring dopaminergic therapy.
Key exclusion criteria: previous Parkinson's disease dopaminergic therapy exposure; nicotine use; major psychiatric disorders; dementia; dermatologic or general medical contraindication for application of transdermal nicotine.
Interventions
N=79 nicotine (transdermal patches supplied as 7 or 14 mg/24 hours; uptitrated to a maximal dose of 28 mg/24 hours for 52 weeks).
N=83 placebo (matching placebo patch for 52 weeks).
Primary outcome
Mean worsening of Total Unified Parkinson's Disease Rating Scale part I-III score at week 60
6 points
3.5 points
6.0 points
4.5 points
3.0 points
1.5 points
0.0 points
Nicotine
Placebo
No significant
difference ↔
No significant difference in mean worsening of Total Unified Parkinson's Disease Rating Scale part I-III score at week 60 (6 points vs. 3.5 points; AD 3 points, 95% CI -0.1 to 6).
Secondary outcomes
Significant increase in mean worsening of Total Unified Parkinson's Disease Rating Scale part I-III score at week 52 (9.1 points vs. 5.4 points; AD 4 points, 95% CI 1 to 7).
No significant difference in improvement in Scales for Outcomes in Parkinson's Disease-Cognition at week 60 (4.3 points vs. 3.3 points; AD 1 points, 95% CI -1 to 2).
No significant difference in worsening of Beck Depression Inventory II at week 60 (1.2 vs. 0.7; AD 1 , 95% CI -1 to 3.1).
Safety outcomes
No significant difference in related serious adverse events.
Conclusion
In patients with Parkinson's disease, diagnosed within 18 months, who were in Hoehn and Yahr disease stage ≤ 2, who were therapy-naïve, and not requiring dopaminergic therapy, nicotine was not superior to placebo with respect to mean worsening of Total Unified Parkinson's Disease Rating Scale part I-III score at week 60.
Reference
Wolfgang H Oertel, Hans-Helge Müller, Marcus M Unger et al. Transdermal Nicotine Treatment and Progression of Early Parkinson’s Disease. NEJM Evid. 2023 Sep;2(9):EVIDoa2200311.
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