LEAP trial (2019): Early vs Delayed Levodopa in Parkinson’s Disease
LEAP Trial Summary: The LEAP trial was a Multicenter, randomized, double-blind, placebo-controlled, delayed-start trial that randomized 445 patients with Parkinson’s disease (mean age 65) and similar baseline clinical characteristics to early-start group (levodopa + cardbidopa for 80 weeks) (n=222) or delayed-start group (Placebo for 40 wks then levodopa + cardbidopa for 40 weeks) (n=223). The primary objective of the study was to evaluate whether levodopa has a disease-modifying effect on patients with early Parkinson’s disease who had insufficient disability to warrant treatment with antiparkinson medication. No difference was found in the primary outcome of change in UPDRS score from baseline to week 80 among both groups (p=0.44). The authors of LEAP trial concluded that Treatment with levodopa in combination with carbidopa had no disease- modifying effect, either beneficial or detrimental, on early Parkinson’s disease among patients who were evaluated over the course of 80 weeks.