A Study to Establish a Parkinson’s Disease (PD) Cohort using the Parkinson’s Progression Markers Initiative (PPMI)

Overview

About this study

The Parkinson Progression Marker Initiative (PPMI) is a 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 PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria (Healthy Control):

  • Male or female age 30 years or older at Screening visit.
  • Individuals taking any of the following drugs must be willing and medically able to hold the medication for at least 5 half-lives before DaTscan imaging:
    • Alpha methyldopa;
    • Methylphenidate;
    • Amphetamine derivatives;
    • Modafinil.
  • 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 (Healthy Control):

  • First degree relative with PD (parent, sibling, child).
  • Current or active clinically significant neurological disorder (in the opinion of 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 within 6 months of Screening visit:
    • Dopamine receptor blockers (neuroleptics)
    • Metoclopramide
    • Reserpine
  • eCurrent treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin inhibitors) that might preclude safe completion of the 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.

Inclusion Criteria (PD):

  • Male or female age 30 years or older at Screening Visit.
  • A diagnosis of Parkinson disease for 2 years or less at Screening Visit.
  • Not expected to require PD medication within at least 6 months from Baseline.
  • Patients must have at least two of the following:
    • Resting tremor;
    • Bradykinesia;
    • Rigidity (must have either resting tremor or bradykinesia);
    • Asymmetric resting tremor;
    • Asymmetric bradykinesia.
  • Hoehn and Yahr stage I or II at Baseline.
  • Individuals taking any of the following drugs must be willing and medically able to hold the medication for at least 5 half-lives before DaTscan imaging:
    • Alpha methyldopa;
    • Methylphenidate;
    • Amphetamine derivatives;
    • Modafinil.
  • 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 (PD):

  • Currently taking levodopa, dopamine agonists, MAO-B inhibitors (e.g., selegiline, rasagiline), amantadine or another PD medication.
  • Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline visit.
  • Has taken levodopa or dopamine agonists prior to Baseline visit 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 within 6 months of Screening visit:
    • Dopamine receptor blockers (neuroleptics);
    • Metoclopramide;
    • Reserpine.
  • Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin inhibitors) that might preclude safe completion of the 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.

Inclusion Criteria (PD - LRRK2 or GBA):

  • Male or female age 30 years or older at Screening Visit.
  • A diagnosis of Parkinson disease for 2 years or less at Screening Visit.
  • Patients must have at least two of the following:
    • Resting tremor;
    • Bradykinesia;
    • Rigidity (must have either resting tremor or bradykinesia);
    • Asymmetric resting tremor;
    • Asymmetric bradykinesia.
  • Hoehn and Yahr stage I or II at Baseline.
  • Confirmation of causative LRRK2 or GBA (willingness to undergo genetic testing as part of genetic screening and be informed of genetic testing results, or documentation of prior genetic testing results).
  • Individuals taking any of the following drugs must be willing and medically able to hold the medication for at least 5 half-lives before DaTscan imaging:
    • Alpha methyldopa;
    • Methylphenidate;
    • Amphetamine derivatives;
    • Modafinil.
  • 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 (PD - LRRK2 or GBA):

  • Received any of the following drugs within 6 months of Screening visit:
    • Dopamine receptor blockers (neuroleptics);
    • Metoclopramide;
    • Reserpine.
  • Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the 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.

Inclusion Criteria (PD - SNCA or rare genetic mutation (such as Parkin or Pink1)):

  • Male or female age 30 years or older at Screening Visit.
  • Parkinson disease diagnosis at Screening Visit.
  • Patients must have at least two of the following:
    • Resting tremor;
    • Bradykinesia;
    • Rigidity (must have either resting tremor or bradykinesia);
    • Asymmetric resting tremor;
    • Asymmetric bradykinesia.
  • Hoehn and Yahr stage I, II, or III at Baseline.
  • Confirmation of causative SNCA or rare genetic mutation (such as Parkin or Pink1) (willingness to undergo genetic testing as part of genetic screening and be informed of genetic testing results, or documentation of prior genetic testing results).
  • Individuals taking any of the following drugs must be willing and medically able to hold the medication for at least 5 half-lives before DaTscan imaging:
    • Alpha methyldopa;
    • Methylphenidate;
    • Amphetamine derivatives;
    • Modafinil.
  • 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 (PD - SNCA or rare genetic mutation (such as Parkin or Pink1)):

  • Received any of the following drugs within 6 months of Screening visit:
    • Dopamine receptor blockers (neuroleptics);
    • Metoclopramide;
    • Reserpine.
  • Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the 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.

Inclusion criteria (Prodromal):

  • Enrolled in PPMI 2.0 Remote and based on risk criteria, or olfaction, and/or other assessments in the PPMI 2.0 Online protocol are eligible for PPMI 2.0 Clinical.
  • Male or female age 60 years or older (except age 30 years or older for SNCA, or rare genetic mutations (such as Parkin or Pink1) participants).
  • 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.
  • Able to provide informed consent. e) 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 (Prodromal):

  • Clinical diagnosis of PD, other Parkinsonism, or dementia.
  • Received any of the following drugs within 6 months of Screening Visit:
    • Dopamine receptor blockers (neuroleptics);
    • Metoclopramide;
    • Reserpine.
  • Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Charles Adler, M.D., Ph.D.

Open for enrollment

Contact information:

Thomas Osgood CCRP

(480) 301-4992

Osgood.Thomas@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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