Principal Investigators

    dr. R.M.A. de Bie



    Contact information of lead PI



    Title of project or programme

    DNA-isolaties LEAP-study

    Source of funding information

    Parkinson Vereniging

    Total sum awarded (Euro)

    € 28,990

    Start date of award


    Total duration of award in years



    Research Abstract

    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 Parkinson’s 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.
    Study design
    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.
    Outcome measures
    The primary outcome measure is the difference between the early-start group and the delayed-start group after 80 weeks, measured with the Unified Parkinson’s Disease rating scale (UPDRS).
    Secondary outcome measures include:
    • the AMC Linear disability Scale (ALDS);
    • side effects;
    • Parkinson’s Disease Questionnaire-39;
    • the EuroQol-5D;
    • ability to (maintain) work, the use of (informal) care, caregiver burden, and costs.

    Further information available at:

Types: Investments < €500k
Member States: Netherlands
Diseases: N/A
Years: 2016
Database Categories: N/A
Database Tags: N/A

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