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Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression (PPMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01141023
Recruitment Status : Recruiting
First Posted : June 10, 2010
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
Institute for Neurodegenerative Disorders
Information provided by (Responsible Party):
Ken Marek, MD, Michael J. Fox Foundation for Parkinson's Research

Brief 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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: DaTscan Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 680 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Parkinson's Progression Markers Initiative (PPMI)
Study Start Date : June 2010
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Datscan SPECT Imaging
Subjects will b injected with 3-5 mCi of dopamine transporter. Within a 4 hour (+/- 30 minutes) window following the injection, subjects will undergo SPECT imaging on the camera.
Drug: DaTscan
Other Name: Ioflupane




Primary Outcome Measures :
  1. Mean Rates of Change [ Time Frame: Baseline to 156 months ]
    The mean rates of change and the variability around the mean of clinical, imaging and biomic outcomes in early PD patients, and where appropriate the comparison of these rates between PD patient subsets and between various subsets (including, but not limited to: PD vs. healthy subjects, PD vs. SWEDD, PD vs. prodromal, PD with and without LRRK2, GBA or SNCA mutation, unaffected LRRK2, GBA or SNCA mutation carriers vs. healthy controls) at study intervals ranging from 3 months to 36 months. Specific examples of outcomes include MDS-UPDRS, dopamine transporter imaging striatal uptake, vesicular monoamine transporter type-2 uptake, and serum and CSF alpha-synuclein. PD patient subsets may be defined by baseline assessments, genetic mutations, progression milestones and/or rate of clinical, imaging, or biomic change.


Secondary Outcome Measures :
  1. Comparison between Rates of Change [ Time Frame: Study intervals ranging from 3 months to 156 months ]
    Comparison between the rates of change in the mean of clinical, imaging and biomic outcomes in various subsets (including, but not limited to: early PD vs. healthy subjects, PD vs. SWEDD, PD vs. prodromal, PD with and without LRRK2, GBA or SNCA mutation, unaffected LRRK2, GBA or SNCA mutation vs. healthy controls)

  2. Prevalence of measures of clinical, imaging and biomic outcomes in various subsets ( [ Time Frame: study intervals ranging from baseline to 156 months. ]
    Including, but not limited to: early PD patients, healthy subjects, PD vs SWEDDs, PD vs prodromal, PD with and without LRRK2, GBA or SNCA mutation, unaffected LRRK2, GBA or SNCA mutation carriers vs. healthy subjects.

  3. Predictive Value [ Time Frame: Baseline to 156 months ]
    To establish the predictive value of early clinical non-motor features, baseline imaging and biomic outcomes for future course of disease.

  4. To examine the proportion of SWEDD subjects that have a change in their clinical management at 24 months [ Time Frame: Baseline to 156 Months ]
    SWEDD Clinical Diagnosis and Management Questionnaire.

  5. Exploratory Analysis [ Time Frame: Baseline to 156 months ]
    Exploratory analysis to estimate the percentage of Prodromal subjects with one or more risk characteristics [hyposmia (<10th percentile for age and gender), RBD, or LRRK2, GBA or SNCA genetic mutation, and baseline DaTSCAN binding showing minimal to moderate DAT deficit] that phenoconvert to PD within 2 years, and an exploratory analysis to examine whether the baseline DaTSCAN binding or progression of clinical, imaging, or biospecimen markers may predict those subjects likely to phenoconvert.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
  7. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
  8. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  9. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
  10. 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).
  11. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).

Genetic Cohort: Parkinson Disease Subjects - Inclusion:

  1. Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting remor or bradykinesia) or either asymmetric resting tremor or asymmetric bradykinesia.
  2. A diagnosis of Parkinson Disease for 7 years or less at screening.
  3. Hoehn and Yahr state <4 at baseline
  4. Male or female age 18 years or older
  5. Willingness to undergo genetic testing and to be informed of genetic testing results.
  6. Confirmation of mutation in LRRK2, GBA or SNCA
  7. For subjects taking any drugs that might interfere with dopamine transporter SPECT imaging (Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine or amphetamine derivative must be willing and able from a medical standpoint to hold the medication for at least 5 half-lives prior to screening DatSCAN(TM) imaging.

Exclusion:

  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.

Genetic cohort - Unaffected Individuals

Inclusion:

  1. Male or female age 45 years or older at baseline with LRRK2 or GBA mutation and/or first degree relative with a LRRK2 or GBA mutation or
  2. Male or female age 30 years or older at baseline with a SNCA mutation and/or a first degree relative with a SNCA mutation.
  3. Unaffected subjects at high risk of LRRK2, GBA or SNCA mutation due to first degree relative with a LRRK2, GBA or SNCA mutation may choose either to be informed of the results or remain unaware of the results.
  4. Unaffected subjects from an ethnic or geographic group knkown to have relatively high risk of LRRK2, GBA or SNCA mutation such as people of Ashkenazi Jewish or Basques descent) and who have a family member (either alive or deceased) who has/had PD must be willing to be informed of their own testing results.
  5. Willingness to undergo genetic testing
  6. For subjects taking any of the following drugs that might interfere with dopamine transporter SPECT imaging (neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine or amphetamine derivative) must be willing and able from a medical standpoint to hold the medication for at least 5 half-lives prior to DatSCAN imaging.

Exclusion:

  1. A clinical diagnosis of PD
  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.

Genetic Registry - Inclusion:

  1. Individual with a LRRK2, GBA or SNCA mutation and/or a first degree relative with a LRRK2, GBA or SNCA mutation.
  2. Male or female age 18 years or older
  3. Willingness to undergo genetic testing, but may choose either to be informed of the results or remain unaware of the results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141023


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Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Courtney Blair, MA    205-975-2894    courtneyblair@uabmc.edu   
Contact: Jenna Smith, RN, BSN    205-996-2807    jennat@uab.edu   
Principal Investigator: David G. Standaert, MD PHD         
Sub-Investigator: Victor Sung, MD, PhD         
Sub-Investigator: Amy Amara, MD, PhD         
United States, Arizona
Banner Research Institute Recruiting
Sun City, Arizona, United States, 85351
Contact: Victoria Brown    623-832-6594    victoria.brown@bannerhealth.com   
Contact: Zoran Obradov, CRC    623-875-6526    zoran.obradov@bannerhealth.com   
Sub-Investigator: Sara Dhanani, MD         
Principal Investigator: David Shprecher, DO         
Sub-Investigator: Nicholas Weisman, MD         
United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093-0948
Contact: Shawnees Peacock    858-822-4800    srpeacock@ucsd.edu   
Contact: Daniel Szpak    858-822-4800    dszpak@ucsd.edu   
Principal Investigator: Douglas Galasko, MD         
Sub-Investigator: Stephanie Lessig, MD         
Sub-Investigator: Irene Litvan, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Farah Kausar    415-379-5530    farah.kausar@ucsf.edu   
Contact: Kathleen Comyns    415-221-4810 ext 3592    kathleen.comyns@ucsf.edu   
Sub-Investigator: Maya Katz, MD         
Sub-Investigator: Nijee Luthra, MD         
Sub-Investigator: Jill Ostrem, MD         
Sub-Investigator: Marta San Luciano, MD, MS         
Principal Investigator: Caroline Tanner, MD         
The Parkinson's Institute Recruiting
Sunnyvale, California, United States, 94085
Contact: Chamu Vadapalli, MPH    408-734-2800    cvadapalli@thepi.org   
Contact: Karthika Jothivel    408-734-2800    kjothivel@parkinsoninstitute.org   
Principal Investigator: Anthony Mosley, MD         
United States, Connecticut
Institute For Neurodegenerative Disorders Recruiting
New Haven, Connecticut, United States, 06510
Contact: Julie Pelaggi    203-401-4300    jpelaggi@indd.org   
Contact: Lianne Ramia, BS    203-401-4300    lramia@indd.org   
Principal Investigator: David Russell, MD         
Sub-Investigator: Joyce Gibbons, PA         
United States, Florida
Parkinson's Disease& Movement Disorder Center of Boca Raton Recruiting
Boca Raton, Florida, United States, 33486
Contact: Lisbeth Carvajal    561-392-1818    lcarvajal@parkinsonscenter.org   
Contact: Ann M Diaz, RN    561-392-1818    adiaz@parkinsonscenter.org   
Principal Investigator: Stuart Isaacson, MD         
Sub-Investigator: Nisha Chhabria, MD         
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Leigh Harrell    813-396-0768    leighharrell@health.usf.edu   
Principal Investigator: Robert Hauser, MD         
Sub-Investigator: Deborah Burke, MD         
Sub-Investigator: Kelly Tehan, PA         
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30329
Contact: Barbara Sommerfeld, MSN, RN    404-712-6997    bsommer@emory.edu   
Contact: Cathy Wood-Siverio, MS    404-728-4782    cwoodsi@emory.edu   
Principal Investigator: Stewart A Factor, DO         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Karen Williams    312-503-5645    k-williams8@northwestern.edu   
Contact: Heidi Friedeck    312-503-1522    heidi.friedeck@northwestern.edu   
Principal Investigator: Tanya Simuni, MD         
Sub-Investigator: Cindy Zadikoff, MD FRCPC         
United States, Maryland
John Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Kori Ribb    413-287-7850    klough2@jhmi.edu   
Contact: Sydney Baybayan    410-955-692    sbaybay1@jhmi.edu   
Sub-Investigator: Ted Dawson, MD PhD         
Sub-Investigator: Zoltan Mari, MD         
Principal Investigator: Liana Rosenthal, MD         
United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02118
Contact: Cathi Thomas, RN MS    617-638-7737    neurocat@bu.edu   
Contact: Ray C. James    617 638-7745    rcjames@bu.edu   
Principal Investigator: Marie H. Saint-Hilaire, MD         
Sub-Investigator: Anna Hohler, MD         
United States, New York
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Deborah Raymond    212-844-8713    draymond@chpnet.org   
Contact: Sonya Elango    212-844-6053    sonya.elango@mountsinai.org   
Principal Investigator: Susan Bressman, MD         
Sub-Investigator: Naomi Lubar, MD         
Sub-Investigator: Joan Miravite, NP         
Sub-Investigator: Lindsey Neimand         
Sub-Investigator: Kimberly Peters, MD         
Sub-Investigator: ivka Sachdev, MD         
Sub-Investigator: Rachel Saunders-Pullman, DM         
Sub-Investigator: Clar Elana         
Sub-Investigator: Katherine Leaver         
Sub-Investigator: Hwai Yin OOI         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Helen M. Santana    212-305-9183    hm28@cumc.columbia.edu   
Contact: Martha O Reilly, MD    212-305-8873    mo404@cumc.columbia.edu   
Principal Investigator: Karen Marder, MD, MPH         
University of Rochester Recruiting
Rochester, New York, United States, 14620
Contact: Nicole Guerrero    585-341-7579    nicole_guerrero@urmc.rochester.edu   
Contact: Carol Zimmerman, RN    585-341-7517    ppmi@urmc.rochester.edu   
Principal Investigator: Irene Richards, MD         
United States, Ohio
University of Cincinnati/Cincinnati Children's Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Misty Wethington    513-558-0142    wethinml@ucmail.uc.edu   
Contact: Erin Neefus    513-558-6555    neefusem@ucmail.uc.edu   
Principal Investigator: Alberto Espay, MD, MSC         
Sub-Investigator: Andrew Duker, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jennifer Mule, BS    216-444-1134    mulej@ccf.org   
Contact: Chris Firestone, BS    216-445-5637    firestc@ccf.org   
Principal Investigator: Hubert H. Fernandez, MD         
Sub-Investigator: Anwar Ahmed, MD         
Sub-Investigator: Ilia Itin, MD         
United States, Oregon
Oregon Health &Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Katrina Wakeman    503-494-1382    wakeman@ohsu.edu   
Contact: Alison Freed    503-494-1382    freeal@ohsu.edu   
Principal Investigator: Penelope Hogarth, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Whitney Richardson    215-829-7374    wjea@pennmediine.upenn.edu   
Contact: Rachael Purri    215 829 6952    rachel.purri@uphs.upenn.edu   
Sub-Investigator: Rizwan Akhtar, MD,PhD         
Sub-Investigator: David Coughlin, MD         
Principal Investigator: nabila Dahodwala, MD         
Sub-Investigator: Thomas Tropea, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Christine Hunter, RN    713-798-3951    chunter@bcm.edu   
Contact: J. Elaine Adams    713-798-0106    june.adams@bcm.edu   
Principal Investigator: Joseph Jankovic, MD         
Sub-Investigator: Joohi Shahed, MD         
United States, Washington
Univ of Washington and VA Puget Sound Health Care System Recruiting
Seattle, Washington, United States, 98104
Contact: Krista Specketer    206-277-5055    kristasp@uw.edu   
Contact: Mary Dyrland    206-277-6977    dyrlandm@seattleu.edu   
Principal Investigator: Shu-Ching Hu, MD, PhD         
Australia
Macquarie University Recruiting
Sydney, Australia, NSW2109
Contact: Madelaine Ranola    +61-298-123-720    madelaine.ranola@me.com   
Principal Investigator: Dominic Rowe         
Austria
Innsbruck Medical University Recruiting
Innsbruck, Austria, 6020
Contact: Beatrice Heim, MD    43 512 504 25812    beatrice.heim@tirol-kliniken.at   
Contact: Raphaela Stolz, BSC    0043-512504-25810    raphaela.stolz@tirol-kliniken.at   
Principal Investigator: Werner Poewe, MD         
Sub-Investigator: Klaus Seppi, MD         
Sub-Investigator: Sabine Spielberger         
Sub-Investigator: Sweta Bajaj, MD         
Sub-Investigator: Atbin Djamshidian, PhD         
Sub-Investigator: Beatrice Heim, MD         
Sub-Investigator: Marina Peball         
Sub-Investigator: Bernadette Pinter, MD         
Sub-Investigator: Mario Werkmann, MD         
France
Hospital Pitie-Salpetriere Recruiting
Paris, France, 75013
Contact: Benjamin LeToullec    331 4216 5520    benjamin.letoullec@icm-institute.org   
Contact: Vanessa Batista    0033-01 42 16 57 61    vanessa.brochard-ext@aphp.fr   
Sub-Investigator: Alexis Brice         
Sub-Investigator: Florence Cormier-Dequaire, MD         
Principal Investigator: Jean-Christophe Corvol, MD         
Sub-Investigator: Graziella Mangone, MD         
Germany
Paracelsus-Elena Klinik Recruiting
Kassel, Germany, 34128
Contact: Diana Willeke    49 561 6009 272    diana.willeke@pk-mx.de   
Contact: Sandra Gesse    49 561 6009-272    sandra.gesse@paracelsus-kliniken.de   
Principal Investigator: Brit Mollenhauer, MD         
University of Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Ella Hilt    +49 7072 298621    tanja.heger@med.uni-tuebingen.de   
Contact: Tanja Heger    +49 7072 2983621    tania.heger@med.uni-tuebingen.de   
Sub-Investigator: Isabel Wurster         
Principal Investigator: Kathrin Brockmann, MD         
Sub-Investigator: Machetanz Gerrit         
Sub-Investigator: Helga Holzmann         
Sub-Investigator: Benjamin Roben, MD         
Sub-Investigator: Milan Zimmerman         
Greece
Foundation for Biomedical Research of the Academy of Athens Recruiting
Athens, Greece, 11523
Contact: Maria Stamelou, MD, PhD    0030 2105832493    mariastamelou@gmail.com   
Sub-Investigator: Christos Koros, MD, PhD         
Sub-Investigator: Maria Stamelou, MD, PhD         
Principal Investigator: Leonidas Stefanis, MD, PhD         
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Anat Mirelman, PhD    972 3 6973960    anatmi@tlvmc.gov.il   
Contact: Efrat Sales    03 6973014    efratsa@tivmc.gov.il   
Principal Investigator: Nir Giladi         
Sub-Investigator: Anat Mirelman, PhD         
Italy
Universita Federico II Recruiting
Napoli, Italy, 80131
Contact: Susan Ainscough, BA    39 340 519 2659    ricercaparkinson@gmail.com   
Principal Investigator: Paolo Barone, MD, PhD         
Sub-Investigator: Autilia Cozzolino, MD         
Sub-Investigator: Alfonso Mauro         
Sub-Investigator: Giampiero Volpe, MD         
University of Salerno Recruiting
Salerno, Italy, 84131
Contact: Susan Ainscough, BA    39 340 519 2659    ricercaparkinson@gmail.com   
Principal Investigator: Paolo Barone, MD, PhD         
Sub-Investigator: Autilia Cozzolino, MD         
Sub-Investigator: Maria Teresa Pellecchia, MD PhD         
Sub-Investigator: Marina Picillo, MD         
Sub-Investigator: Massimo Squillante, MD         
Sub-Investigator: Enza Maria Valente, MD, PhD         
Sub-Investigator: Giampiero Volpe, MD         
Norway
St. Olavs Hospital Recruiting
Trondheim, Norway, 7006
Contact: Anne Grete Kristiansen    47072573528    anne.g.kristiansen@ntnu.no   
Contact: Bjorg Johanne Waro    47 911 08 377    bjorg.waro@ntnu.no   
Principal Investigator: Jan O. Aasly, MD         
Sub-Investigator: Bjorg Waro         
Spain
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Alicia Garrido, MD    34 932275785    agarridop@clinic.ub.es   
Contact: Donina Mese Obiang Mangue    34 646699750    dobiang@outlook.com   
Sub-Investigator: Ana Fernandez         
Sub-Investigator: Alicia Garrido, MD         
Sub-Investigator: Alex Iranzo         
Sub-Investigator: Maria Jose Marti         
Sub-Investigator: Cristina Simonet         
Principal Investigator: Eduardo Tolosa, MD         
Hospital Donostia Recruiting
San Sebastian, Spain, 20014
Contact: Ioana Croitoru    +34 943 00 72 46    ioana.croitoru@biodonostia.org   
Contact: Elisabet Mondragon Rezola    34 94 300 5 33    elisabet.mondragonrezola@osakidetza.net   
Principal Investigator: Maria De Arriba Sanchez         
Principal Investigator: Javier Ruiz Martinez, MD         
United Kingdom
Imperial College London Recruiting
London, United Kingdom, W12 0NN
Contact: Phillip Poku    02033111714    p.poku@nhs.net   
Contact: Gitamjali Sharma    744 203 311 1714    gita.sharma@imperial.nhs.uk   
Sub-Investigator: David Brooks, MD         
Sub-Investigator: Sophie Molloy, MD         
Principal Investigator: Yen Tai, MD         
Sub-Investigator: Jenny Vaughan, MD, PhD         
Sponsors and Collaborators
Ken Marek, MD
Institute for Neurodegenerative Disorders
Investigators
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Study Chair: Kenneth L Marek, MD Institute for Neurodegenerative Disorders
Study Director: John Q. Trojanowski, MD, PhD University of Pennsylvania
Study Director: Arthur W. Toga, PhD University of California, Los Angeles
Study Director: Tatiana Froud, PhD Indiana University
Study Director: Karl Kieburtz, MD Clinical Trials Coordination Center
Study Director: Andrew Singleton, PhD Laboratory of Neurogenetics; National Institute on Aging NIH
Study Director: John P Seibyl, MD Institute for Neurodegenerative Disorders
Study Director: Christopher Coffey, PhD Clinical Trials Statistical and Data Management Center, University of Iowa

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ken Marek, MD, Study Chair, Michael J. Fox Foundation for Parkinson's Research
ClinicalTrials.gov Identifier: NCT01141023     History of Changes
Other Study ID Numbers: PPMI-001
First Posted: June 10, 2010    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Keywords provided by Ken Marek, MD, Michael J. Fox Foundation for Parkinson's Research:
Parkinson
Bio-markers
Neurodegenerative disorder
Imaging
Prodromal
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases