dr. R.M.A. de Bie
The current mainstay of PD-treatment consists of dopamine replacement with levodopa or dopamine-agonists.
There is considerable debate about when and how to initiate pharmacological therapy. Although current guidelines indicate that symptomatic treatment for Parkinsons disease (PD) should be started when functional health is hindered, most neurologists still delay starting symptomatic treatment. This results in an acceptance of disability early in the disease.
The results of recent studies suggest that early treatment with levodopa might have a thus far unrecognized delayed beneficial effect on PD symptoms.
To investigate whether early treatment with levodopa has a delayed beneficial effect on:
PD symptoms and functional health;
improves the ability to (maintain) work; and
reduces the use of (informal) care, caregiver burden, and costs.
Additionally, cost-effectiveness and cost-utility of early levodopa treatment will be assessed.
The study is a prospective, randomized, delayed-start, double blind, placebo-controlled multicenter trial and started in August 2011.
In 30 months 446 patients with newly diagnosed PD, that do not need symptomatic treatment judged by the treating neurologist, will be included.
For 40 weeks, patients will receive either levodopa/carbidopa 100/25 mg TID or placebo; the last 40 weeks, all patients will receive levodopa/carbidopa 100/25 mg TID.
There are 8 assessments, all of which will be performed by trained research-nurses.
The primary outcome measure is the difference between the early-start group and the delayed-start group after 80 weeks, measured with the Unified Parkinsons Disease rating scale (UPDRS).
Secondary outcome measures include:
the AMC Linear disability Scale (ALDS);
Parkinsons Disease Questionnaire-39;
ability to (maintain) work, the use of (informal) care, caregiver burden, and costs.