Developing a collection of clinical, imaging and biologic specimens to identify biological markers of Parkinson’s risk, onset and progression

Does collecting data from participants with Parkinson's Disease allow identification of markers of disease?

Lead Researcher: Ruth Schneider

The Parkinson Progression Marker Initiative 2.0 (PPMI 2.0) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of the study is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

More Details:

• https://clinicaltrials.gov/ct2/show/NCT04477785

Eligibility:

Inclusion Criteria:

        Healthy Control (HC) Subjects:

          -  Male or female age 30 years and older at Screening visit.

          -  Individuals taking any of the following drugs: alpha methyldopa, methylphenidate,
             amphetamine derivatives or modafinil, must be willing and medically able to hold the
             medication for at least 5 half-lives before DaTscan imaging.

          -  Confirmation that participant is eligible based on Screening DaTscan imaging.

          -  Able to provide informed consent

          -  Women may not be pregnant, lactating or planning pregnancy during the study. ~
             Includes a negative pregnancy test on day of Screening DaTscan imaging test prior to
             injection of DaTscan™.

        Exclusion Criteria:

        Parkinson Disease (PD) Subjects:

          -  Currently taking levodopa, dopamine agonists, MAO-B inhibitors (e.g., selegiline,
             rasagiline), amantadine or other PD medication.

          -  Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days
             of Baseline.

          -  Has taken levodopa or dopamine agonists prior to Baseline for more than a total of 90
             days.

          -  Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine,
             neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis, or
             degenerative diseases (e.g., progressive supranuclear palsy)

          -  A clinical diagnosis of dementia as determined by the investigator.

          -  Previously obtained MRI scan with evidence of clinically significant neurological
             disorder (in the opinion of the Investigator)

          -  Received any of the following drugs: dopamine receptor blockers (neuroleptics),
             metoclopramide and reserpine within 6 months of Screening visit.

          -  Current treatment with anticoagulants (e.g. coumadin, heparin, oral thrombin
             inhibitors) that might preclude safe completion of lumbar puncture.

          -  Condition that precludes the safe performance of routine lumbar puncture, such as
             prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant
             coagulopathy or thrombocytopenia.

          -  Any other medical or psychiatric condition or lab abnormality, which in the opinion of
             the investigator might preclude participation.

        Healthy Control (HC) Subjects:

          -  Current or active clinically significant neurological disorder (in the opinion of the
             Investigator).

          -  First degree relative with PD (parents, siblings or children with PD)

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