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Eligibility
for people ages 30 years and up
Healthy Volunteers
healthy people welcome
Location
at Sunnyvale, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes. The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.

Official Title

The Parkinson's Progression Markers Initiative (PPMI)

Details

PPMI will be a five-year natural history study (a minimum of 3-year involvement for each subject) of de novo idiopathic PD patients and healthy controls. This study will also include a SWEDD (subjects without evidence of dopaminergic deficit)and Prodromal populations.

All subjects will be comprehensively assessed at baseline and every three to six months thereafter. Subjects will undergo clinical (motor, neuropsychiatric and cognitive) and imaging assessments and will donate blood, urine, and cerebral spinal fluid (CSF). A blood sample for DNA will be collected. Data will be collected by each site under uniformly established protocols and data will be analyzed and stored at designated core facilities.

Keywords

Parkinson Disease Parkinson Bio-markers Neurodegenerative disorder Imaging Prodromal

Eligibility

You can join if…

Open to people ages 30 years and up

Parkinson Disease (PD) Subjects:

  • A diagnosis of Parkinson disease for 2 years or less at Screening.
  • Confirmation from imaging core that screening DAT scan is consistent with dopamine transporter deficit, or if applicable a VMAT-2 PET scan consistent with vesicular monoamine transporter deficit.
  • Not expected to require PD medication with at least 6 months from Baseline.
  • Male or female age 30 years or older at time of PD diagnosis.

Healthy Control (HC) Subjects:

• Male or female age 30 years or older at Screening.

You CAN'T join if...

Parkinson Disease (PD) Subjects:

  • Currently taking levodopa, dopamine agonists, MAO-B inhibitors, 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 60 days.
  • Received any of the following drugs that might interfere with DAT imaging:Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening.
  • Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.

    If applicable, currently taking medications that are known to cause QT-prolongation, or are currently taking tetrabenazine (TBZ or amphetamine type medications.

  • Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  • Use of investigational drugs within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).

Healthy Control (HC) Subjects:

  • Current or active neurological disorder.
  • First degree relative with idiopathic PD (parent, sibling, child).
  • MoCA score < 26.
  • Received any of the following drugs that might interfere with DAT imaging:Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening.

    If applicable, currently taking medications that are known to cause QT-prolongation, or are currently taking tetrabenazine (TBZ) or amphetamine type medications.

  • 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.
  • Use of other investigational drugs within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).

SWEDD Subjects:

All PD criteria apply, as above, except a SWEDD subject must have confirmation from imaging core that screening dopamine transporter SPECT scan shows no evidence of dopamine transporter deficit or if applicable a VMAT-2 PET scan shows no evidence of vesicular monoamine transporter deficit.

Prodromal Subjects:

Inclusion Criteria (Prodromal Subjects) 4.2.7.1. Subjects must have at least one of the following characteristics:

Hyposmia:

  1. Male or female age 60 years or older
  2. Confirmation from olfactory core that olfaction as determined by UPSIT is at or below the 10th percentile by age and gender

REM Behavior Disorder (RBD):

  1. Male or female age 60 years or older
  2. Confirmation from sleep core that subject's Polysomnography (PSG) meets criteria for RBD

LRRK2:

  1. Male or female age 60 years or older
  2. Written confirmation or documentation from testing facility that the individual is LRRK2 mutation positive 4.2.7.2. Confirmation from imaging core that screening dopamine transporter SPECT scan is read as eligible (see below). About 80 subjects will have a range of DAT deficit similar to subjects with early PD (mild to moderate DAT deficit). About 20 subjects will be selected with no DAT deficit or minimal DAT deficit similar in age, gender, and risk profile to those with mild to moderate DAT deficit. 4.2.7.3. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations. 4.2.7.4. Willing and able to comply with scheduled visits, required study procedures and laboratory tests. 4.2.7.5. Women may not be pregnant, lactating or planning pregnancy during the course of the study. Includes a negative urine pregnancy test on day of screening scan prior to injection (DaTSCAN).

Exclusion Criteria (Prodromal Subjects)

  1. Current or active clinically significant neurological disorder or psychiatric disorder (in the opinion of the Investigator).
  2. GDS score greater than or equal to 10 (GDS score of 5 - 9 requires Investigator discretion to enter study).
  3. STAI Form Y-1 greater than or equal to 54 requires Investigator discretion to enter study.
  4. A clinical diagnosis of dementia63 as determined by the investigator (Appendix 1).
  5. A clinical diagnosis of Parkinson disease at the Screening visit as determined by the Investigator.
  6. Received any of the following drugs that might interfere with dopamine transporter

SPECT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate,reserpine, or amphetamine derivative, within 6 months of Screening.

  1. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
  2. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  3. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
  4. Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
  5. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).

Locations

  • The Parkinson's Institute accepting new patients
    Sunnyvale, California, 94085, United States
  • University of California San Diego accepting new patients
    La Jolla, California, 92093-0948, United States
  • Banner Research Institute accepting new patients
    Sun City, Arizona, 85351, United States
  • Oregon Health &Science University accepting new patients
    Portland, Oregon, 97239, United States
  • Univ of Washington and VA Puget Sound Health Care System accepting new patients
    Seattle, Washington, 98104, United States
  • Baylor College of Medicine accepting new patients
    Houston, Texas, 77030, United States
  • Northwestern University accepting new patients
    Chicago, Illinois, 60611, United States
  • University of Alabama at Birmingham accepting new patients
    Birmingham, Alabama, 35294, United States
  • University of Cincinnati/Cincinnati Children's Hospital accepting new patients
    Cincinnati, Ohio, 45219, United States
  • Emory University School of Medicine accepting new patients
    Atlanta, Georgia, 30329, United States
  • Cleveland Clinic accepting new patients
    Cleveland, Ohio, 44195, United States
  • University of South Florida accepting new patients
    Tampa, Florida, 33606, United States
  • University of Rochester accepting new patients
    Rochester, New York, 14620, United States
  • John Hopkins University accepting new patients
    Baltimore, Maryland, 21287, United States
  • University of Pennsylvania accepting new patients
    Pennsylvania, Pennsylvania, 19107, United States
  • Parkinson's Disease& Movement Disorder Center of Boca Raton accepting new patients
    Boca Raton, Florida, 33486, United States
  • Institute For Neurodegenerative Disorders accepting new patients
    New Haven, Connecticut, 06510, United States
  • Boston University accepting new patients
    Boston, Massachusetts, 02118, United States
  • Imperial College London accepting new patients
    London, W12 0NN, United Kingdom
  • Paracelsus-Elena Klinik accepting new patients
    Kassel, 34128, Germany
  • University of Tuebingen accepting new patients
    Tuebingen, 72076, Germany
  • Innsbruck Medical University accepting new patients
    Innsbruck, 6020, Austria
  • Universita Federico II accepting new patients
    Napoli, 80131, Italy
  • Macquarie University accepting new patients
    Sydney, NSW2109, Australia

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ken Marek, MD
ID
NCT01141023
Phase
Phase 2
Lead Scientist
Caroline Tanner
Study Type
Interventional
Last Updated
September 12, 2016
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