The Parkinson s Progression Markers Initiative (PPMI) 2.0 Clinical - Establishing a Deeply Phenotyped PD Cohort

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Parkinson's Disease
  • Age: Between 30 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    Healthy Participants:
    1. 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
    2. Confirmation that participant is eligible based on Screening DaTscan imaging
    3. Able to provide written informed consent
    4. Women may not be pregnant, lactating or planning pregnancy during the study
    Parkinson Disease (PD) Participants:
    1. A diagnosis of Parkinson disease for 2 years or less
    2. Not expected to require PD medication within at least 6 months
    3. Must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia
    4. Have Hoehn and Yahr stage I or II of Parkinson Disease
    5. 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
    6. Confirmation that participant is eligible based on Screening DaTscan imaging
    7. Able to provide written informed consent
    8. Women may not be pregnant, lactating or planning pregnancy during the study
    Parkinson Disease (PD) with LRRK2 or GBA mutation
    1. A diagnosis of Parkinson disease for 2 years or less
    2. Participants must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia
    3. Have Hoehn and Yahr stage I or II of Parkinson Disease
    4. 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)
    5. 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
    6. Confirmation that participant is eligible based on Screening DaTscan imaging
    7. Able to provide written informed consent
    8. Women may not be pregnant, lactating or planning pregnancy during the study
    Parkinson Disease (PD) with SNCA or rare genetic mutation
    1. Have Parkinson disease diagnosis
    2. Participants must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia
    3. Have Hoehn and Yahr stage I or II of Parkinson Disease
    4. 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)
    5. 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
    6. Confirmation that participant is eligible based on Screening DaTscan imaging
    7. Able to provide written informed consent
    8. Women may not be pregnant, lactating or planning pregnancy during the study
    Prodromal
    1. 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
    2. Participants 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
    3. Able to provide written informed consent
    4. Women may not be pregnant, lactating or planning pregnancy during the study

You may not be eligible for this study if the following are true:

  • Healthy Participants
    1. First degree relative with PD (parent, sibling, child)
    2. Current or active clinically significant neurological disorder
    3. Previously obtained MRI scan with evidence of clinically significant neurological disorder
    4. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months
    5. Current treatment with anticoagulants that might preclude safe completion of the lumbar puncture
    6. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia
    7. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation
    Parkinson Disease (PD) Participants:
    1. Currently taking levodopa, dopamine agonists, MAO-B inhibitors (e.g., selegiline, rasagiline), amantadine or another PD medication
    2. Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days
    3. as taken levodopa or dopamine agonists prior to Baseline visit for more than a total of 90 days
    4. Atypical PD syndromes due to either drugs or metabolic disorders, encephalitis, or degenerative diseases
    5. A clinical diagnosis of dementia
    6. Previously obtained MRI scan with evidence of clinically significant neurological disorder
    7. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months
    8. Current treatment with anticoagulants that might preclude safe completion of the lumbar puncture
    9. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia
    10. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation
    Parkinson Disease (PD) with LRRK2 or GBA mutation
    1. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months
    2. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture
    3. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia
    4. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation
    Parkinson Disease (PD) with SNCA or rare genetic mutation
    1. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months
    2. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture
    3. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia
    4. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation
    Prodromal
    1. Clinical diagnosis of PD, other parkinsonism, or dementia
    2. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening Visit
    3. Current treatment with anticoagulants (e.g. coumadin, heparin) that might preclude safe completion of the lumbar puncture
    4. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia
    5. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation



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