PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort (PPMI)

• ClinicalTrials.gov Identifier: NCT04477785
• Recruitment Status: Recruiting
• First Posted: July 20, 2020
• Last Update Posted: December 14, 2023
• Sponsor: Michael J. Fox Foundation for Parkinson's Research
• Collaborator: Institute for Neurodegenerative Disorders
• Information provided by (Responsible Party): Ken Marek, MD, Institute for Neurodegenerative Disorders

Study Description

Brief Summary:

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

Condition or disease
Parkinson Disease

Detailed Description:

PPMI is a broad program, expanding the goals of the original PPMI study, that includes this PPMI Clinical protocol, as well as other program initiatives such as the PPMI Remote, PPMI Digital App and PPMI Online protocols. Participants in PPMI may be asked to be enrolled in other PPMI program protocols, but depending on their method of recruitment, participants may be enrolled sequentially in varying order, as appropriate. PPMI participants may also be asked to participate in additional PPMI program initiatives (as they are developed), which may only involve a subset of PPMI participants based on their cohort designation and/or site location.

Study Design

• Study Type: Observational
• Estimated Enrollment: 4500 participants
• Observational Model: Case-Control
• Time Perspective: Other
• Official Title: The Parkinson's Progression Markers Initiative (PPMI) Clinical - Establishing a Deeply Phenotyped PD Cohort
• Actual Study Start Date: July 1, 2020
• Estimated Primary Completion Date: December 2033
• Estimated Study Completion Date: December 2033

Groups and Cohorts

Group/Cohort
Clinical Observation; In PPMI Clinical up to 4,500 participants will be enrolled and followed longitudinally once identified, over the course of 5-8 years.

Outcome Measures

Primary Outcome Measures :

1. Establish standardized protocols for acquisition, transfer and analysis of clinical, digital, imaging, biologic and genetic data that can be used by the PD research community. [ Time Frame: Baseline to 156 months ]
   This protocol will build on the existing PPMI infrastructure
2. Comprehensive and uniformly acquired dataset [ Time Frame: Baseline to 156 months ]
   Develop a comprehensive and uniformly acquired clinical, digital and imaging dataset and repository of biological and genetic samples that would be available to the PD research community to test hypotheses of the underlying molecular pathobiology of PD, enable modeling of PD progression to identify clinical and/or data driven PD progression sub-sets, and inform studies testing PD therapeutics (for examples, clinical trials targeting synuclein, LRRK2, GBA as well as other targets)
3. Comparison between Rates of Change [ Time Frame: Study intervals ranging from 3 months to 156 months ]
   Use clinical and biological data to estimate the mean rates of change and the variability around the mean of clinical, digital, imaging, biological and genetic outcomes in study participants with PD diagnosis (including patients with a LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1) and individuals with prodromal Parkinson's disease (including individuals with REM sleep behavior disorder (RBD)), olfactory loss, LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1) and/or other risk factors for PD with and without dopamine transporter (DAT) deficit and in healthy participants.
4. Prevalence of measures of clinical, imaging and biomic outcomes in various subsets [ Time Frame: study intervals ranging from baseline to 156 months. ]
   Confirm existing and identify novel clinical, digital, imaging, biologic and genetic PD progression markers to identify quantitative individual measures or combinations of measures that demonstrate optimum interval change in study participants with PD diagnosis (including patients with a LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1)) and individuals with prodromal Parkinson's disease (including individuals with RBD, olfactory loss, a LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1) and/or other risk factors for PD with and without DAT deficit in comparison to healthy controls or in sub-sets of study participants with PD diagnosis or prodromal PD defined by baseline assessments, progression milestones and/or rate of clinical, digital, imaging, biologic and genetic change, or other measures.
5. Establish the probability of phenoconversion to PD [ Time Frame: study intervals ranging from baseline to 156 months. ]
   Evaluate the probability of phenoconversion to PD for individuals with prodromal PD enrolled in the prodromal cohorts (including individuals with RBD, olfactory loss, a LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1) and/ or other risk factors for PD with and without DAT deficit).

Biospecimen Retention:   Samples With DNA

Blood will be obtained for the extraction of DNA to conduct sequencing and genomic analysis. These maybe collected in a fasted state.

Eligibility Criteria

• Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

In PPMI Clinical up to 4,500 participants will be enrolled and followed longitudinally from approximately 50-55 international clinical sites across a variety of cohorts, including healthy controls, Parkinson disease, PD manifesting gene carriers, and Prodromal (those at risk for developing PD).

Criteria

7.1 Healthy Controls (HC) Note: Active Healthy controls previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).

7.1.1 Inclusion Criteria (HC)

1. Male or female age 57 years or older at Screening visit.
2. 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 SPECT imaging.
3. Confirmation that participant is eligible based on Screening SPECT imaging.
4. Able to provide informed consent.

5. Either is male, or is female and meets additional criteria below, as applicable:

   • Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.

7.1.2 Exclusion Criteria (HC)

1. First degree relative with PD (i.e., biologic parent, sibling, child).
2. Current or active clinically significant neurological disorder (in the opinion of the Investigator).
3. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
4. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.
5. Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin inhibitors) 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.
8. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.

7.2 Parkinson's Disease (PD) Note: Active PD participants previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).

7.2.1 Inclusion Criteria (PD)

1. Male or female age 30 years or older at Screening Visit.
2. A diagnosis of Parkinson's disease for 2 years or less at Screening Visit.
3. Not expected to require PD medication within at least 6 months from Baseline.
4. Patients 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.
5. Hoehn and Yahr stage I or II at Baseline.
6. 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 SPECT imaging.
7. Confirmation that participant is eligible based on Screening SPECT imaging.
8. Able to provide informed consent.

9. Either is male, or is female and meets additional criteria below, as applicable:

   • Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.

7.2.2 Exclusion Criteria (PD)

1. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or another PD medication, except for low-dose treatment of restless leg syndrome (with permission of medical monitor).
2. Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline visit.
3. Has 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 (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy).
5. A clinical diagnosis of dementia as determined by the investigator.
6. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
7. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.
8. Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin inhibitors) 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.
11. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.

7.3 Parkinson's Disease (PD) with LRRK2 or GBA variant Note: Active PD participants previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).

7.3.1 Inclusion Criteria (PD ¬- LRRK2 or GBA)

1. Male or female age 30 years or older at Screening Visit.
2. A diagnosis of Parkinson's disease for 2 years or less at Screening Visit.
3. Patients 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. Hoehn and Yahr stage I or II at Baseline.
5. Confirmation of causative LRRK2 or GBA (willingness to undergo genetic testing as part of genetic screening and be informed of genetic testing results, or approved documentation of prior genetic testing results).
6. 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 SPECT imaging.
7. Confirmation that participant is eligible based on Screening SPECT imaging.
8. Able to provide informed consent.

9. Either is male, or is female and meets additional criteria below, as applicable:

   • Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.

7.3.2 Exclusion Criteria (PD - LRRK2 or GBA)

1. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.
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.
5. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.

7.4 Parkinson's Disease (PD) with SNCA or rare genetic variant Note: Active PD participants previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).

7.4.1 Inclusion Criteria (PD - SNCA or rare genetic variant (such as Parkin or Pink1))

1. Male or female age 30 years or older at Screening Visit.
2. Parkinson's disease diagnosis at Screening Visit.
3. Patients 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. Hoehn and Yahr stage I, II, or III at Baseline.
5. Confirmation of causative SNCA or rare genetic variant (such as Parkin or Pink1) (willingness to undergo genetic testing as part of genetic screening and be informed of genetic testing results, or approved documentation of prior genetic testing results).
6. 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 SPECT imaging.
7. Confirmation that participant is eligible based on Screening SPECT imaging.
8. Able to provide informed consent.

9. Either is male, or is female and meets additional criteria below, as applicable:

   • Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.

7.4.2 Exclusion Criteria (PD - SNCA or rare genetic variant (such as Parkin or Pink1))

1. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.
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.
5. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.

7.5 Prodromal Note: Active Prodromal participants previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).

The specific predictive eligibility criteria for participants recruited through PPMI Remote to advance to PPMI Clinical will be iteratively optimized based on data collected from these studies.

7.5.1 Inclusion criteria (Prodromal)

For Screening:

1. Confirmation that participant is eligible based on centrally determined predictive criteria including the University of Pennsylvania Smell Identification Test (UPSIT).

   • For participants in PPMI Remote, referral to the clinical site confirms predictive eligibility.
   • For participants identified by the clinical site, predictive criteria are based on generalized risk such as first degree biologic relative, known risk of PD including RBD, or known genetic variants associated with PD risk.

   Additionally, confirmation of UPSIT eligibility during the Screening visit prior to SPECT Imaging.

2. Male or female age 60 years or older (except age 30 years or older for SNCA, or rare genetic variants (such as Parkin or Pink1) participants).
3. 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 SPECT imaging.
4. Able to provide informed consent.

5. Either is male, or is female and meets additional criteria below, as applicable:

   • Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.

   For continuation to Baseline visit and ongoing follow-up:

6. Confirmation that participant is eligible based on *Screening SPECT imaging.

   • Screening SPECT Imaging eligibility:

Based on the results of the SPECT imaging test, Prodromal participants eligible to continue their participation in PPMI Clinical will be asked to return for their PPMI Clinical baseline visit. Neither the participant nor the site investigator will be made aware of the participant's DAT status during the study.

• It is anticipated that approximately 6,000 participants will complete a screening visit to undergo DAT imaging. Approximately 2,000 participants will be eligible to continue their participation in PPMI Clinical (those not eligible to proceed will remain in PPMI Remote, as applicable).
• All participants with DAT deficit will be eligible to continue their participation in PPMI Clinical. It is estimated that about 75% of eligible participants will have a DAT deficit (defined by a hybrid of visual assessment and quantitative striatal specific binding analysis).
• Some participants without DAT deficit will also be eligible to continue their participation in PPMI Clinical. These participants will be chosen based on DAT binding that is reduced from age expected but it not outside the normal range and/or from individuals with high-risk of PD including RBD, LRRK2, GBA, SNCA, or rare genetic variants (such as Parkin or Pink1) that do not demonstrate DAT deficit. It is estimated that about 25% of eligible participants will not have a DAT deficit.
• It is anticipated that approximately 30% of the PPMI Clinical prodromal participants with DAT deficit will phenoconvert to motor parkinsonism during a 3 to 5-year follow-up.

7.5.2 Exclusion Criteria (Prodromal)

1. Clinical diagnosis of PD at screening, other parkinsonism, or dementia.
2. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Baseline 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.
6. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or another PD medication, except for low-dose treatment of restless leg syndrome (with permission of medical monitor).
7. Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline visit. except for low-dose treatment of restless leg syndrome (with permission of medical monitor).
8. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.

Contacts and Locations

Contacts

Contact: Cari Rainville, BS; 877-525-7764; crainville@indd.org

Locations

United States, Alabama

University of Alabama at Birmingham; Recruiting

Birmingham, Alabama, United States, 35294

Contact: PPMI Call Center 877-525-7764

Sub-Investigator: Victor Sung, MD, PhD

Principal Investigator: David Standaert, MD

United States, Arizona

Barrow Neurological Institute; Recruiting

Phoenix, Arizona, United States, 85013

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Holly Shill, MD

Mayo Foundation for Medical Education and Research; Recruiting

Scottsdale, Arizona, United States, 85259

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Charles Adler

Banner Research Institute; Recruiting

Sun City, Arizona, United States, 85351

Contact: PPMI Call Center 877-525-7764

Sub-Investigator: Sara Dhanani, MD

Principal Investigator: David Shprecher

United States, California

University of California San Diego; Recruiting

La Jolla, California, United States, 92093-0948

Contact: PPMI Call Center 877-525-7764 clinicaltrialsadrc@health.ucsd.edu

Principal Investigator: Douglas Galasko, MD

Keck School of Medicine of USC; Recruiting

Los Angeles, California, United States, 90033

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Mark Lew

University of California, San Francisco; Recruiting

San Francisco, California, United States, 94115

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Caroline Tanner, MD

United States, Colorado

University of Colorado Anschutz Medical Campus; Recruiting

Aurora, Colorado, United States, 80045

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Maureen Leehey, MD

United States, Connecticut

Institute For Neurodegenerative Disorders; Recruiting

New Haven, Connecticut, United States, 06510

Contact: PPMI Call Center 877-525-7764

Principal Investigator: David Russell, MD

United States, Florida

Parkinson's Disease& Movement Disorder Center of Boca Raton; Recruiting

Boca Raton, Florida, United States, 33486

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Stuart Isaacson, MD

University of Florida; Recruiting

Gainesville, Florida, United States, 32608

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Nikolaus McFarland

University of South Florida; Recruiting

Tampa, Florida, United States, 33606

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Robert Hauser, MD

United States, Georgia

Emory University School of Medicine; Recruiting

Atlanta, Georgia, United States, 30329

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Stewart A Factor, DO

United States, Illinois

Northwestern University; Recruiting

Chicago, Illinois, United States, 60611

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Tanya Simuni, MD

United States, Kansas

University of Kansas Medical Center; Recruiting

Kansas City, Kansas, United States, 66160

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Rajesh Pahwa, MD

United States, Maryland

Johns Hopkins University; Recruiting

Baltimore, Maryland, United States, 21287

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Emile Moukheiber, MD

United States, Massachusetts

Boston University; Recruiting

Boston, Massachusetts, United States, 02118

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Marie H. Saint-Hilaire, MD

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02446

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Aleksandar Videnovic, MD

United States, Michigan

University of Michigan; Recruiting

Ann Arbor, Michigan, United States, 48109

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Kelvin Chou

United States, Nevada

Cleveland Clinic Lou Ruvo Center for Brain Health; Recruiting

Las Vegas, Nevada, United States, 89106

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Zoltan Mari, MD

United States, New York

Beth Israel Medical Center; Recruiting

New York, New York, United States, 10003

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Katherine Leaver, MD

NYU Langone Health; Recruiting

New York, New York, United States, 10017

Contact: PPMI Call Center 877-525-7764

Sub-Investigator: Un Kang

Principal Investigator: Giulietta Riboldi

Columbia University Medical Center; Recruiting

New York, New York, United States, 10032

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Karen Marder, MD, MPH

University of Rochester; Recruiting

Rochester, New York, United States, 14620

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Ruth Schneider, MD

United States, Ohio

University of Cincinnati/Cincinnati Children's Hospital; Recruiting

Cincinnati, Ohio, United States, 45219

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Alberto Espay, MD, MSC

Cleveland Clinic; Recruiting

Cleveland, Ohio, United States, 44195

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Hubert H. Fernandez, MD

United States, Oregon

Oregon Health &Science University; Recruiting

Portland, Oregon, United States, 97239

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Penelope Hogarth, MD

United States, Pennsylvania

University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Nabila Dahodwala, MD

University of Pittsburgh; Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Lana Chahine, MD

United States, Texas

Baylor College of Medicine; Recruiting

Houston, Texas, United States, 77030

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Arjun Tarakad, MD

United States, Washington

Univ of Washington and VA Puget Sound Health Care System; Recruiting

Seattle, Washington, United States, 98104

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Shu-Ching Hu, MD, PhD

Austria

Innsbruck Medical University; Recruiting

Innsbruck, Austria, 6020

Contact: Corrine Horlings

Principal Investigator: Werner Poewe, MD

Canada, Ontario

The Ottawa Hospital - Civic Campus; Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Tiago Mestre

Toronto Western Hospital; Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Connie Marras

Canada, Quebec

McGill University; Recruiting

Montréal, Quebec, Canada, H3A2B4

Contact: PPMI Call Center 877-525-7764

Principal Investigator: Ron Postuma

Germany

Philipps-University of Marburg; Recruiting

Hessen, Germany, 35043

Contact: Elisabeth Sittig sittig@med.uni-marburg.de

Principal Investigator: Wolfgang Oertel

Paracelsus-Elena Klinik; Recruiting

Kassel, Germany, 34128

Contact: Diana Willeke 49 561 6009 272 diana.willeke@pk-mx.de

Principal Investigator: Brit Mollenhauer, MD

University of Luebeck; Recruiting

Luebeck, Germany, 23562

Contact: Norbert Bruggermann norbert.brueggemann@neuro.uni-luebeck.de

Principal Investigator: Christine Klein, MD

University of Tuebingen; Recruiting

Tuebingen, Germany, 72076

Contact: Ella Hilt +49 7072 298621 ella.hilt@med.uni-tuebingen.de

Sub-Investigator: Isabel Wurster, MD

Principal Investigator: Kathrin Brockmann

Greece

Foundation for Biomedical Research of the Academy of Athens; Recruiting

Athens, Greece, 11523

Contact: Christos Koros 00302107289405 chkoros@gmail.com

Principal Investigator: Leonidas Stefanis, MD, PhD

Israel

Tel Aviv Sourasky Medical Center; Recruiting

Tel Aviv, Israel, 64239

Contact: Anat Mirelman, Bsc 972-3-697-3014 anatmi@tlvmc.gov.il

Principal Investigator: Nir Giladi, MD

Italy

University of Salerno; Recruiting

Salerno, Italy, 84131

Contact: Susan Ainscough, BA 39 340 519 2659 ricercaparkinson@gmail.com

Principal Investigator: Paolo Barone, MD, PhD

Luxembourg

University of Luxembourg; Recruiting

Esch-sur-Alzette, Luxembourg, L-4367

Contact: Tainá Marques 352(466)644-6491 taina.marques@ext.uni.lu

Principal Investigator: Rejko Krueger

Netherlands

Radboud University; Recruiting

Nijmegen, Gelderland, Netherlands, 6525 GC

Contact: Myrthe Burgler myrthe.burgler@radboudumc.nl

Principal Investigator: Baastian Bloem

Nigeria

Lagos College of Medicine, University of Lagos; Recruiting

Lagos, Nigeria, 121010

Contact: Oluwadamilola Ojo 2348033606414 oluojo@unilag.edu.ng

Principal Investigator: Njideka Okubadejo

Spain

Hospital Clinic de Barcelona; Recruiting

Barcelona, Spain, 08036

Contact: Alicia Garrido, MD 34 932275785 agarridop@clinic.ub.es

Principal Investigator: Eduardo Tolosa, MD

Principal Investigator: Maria Jose Marti

Hospital Donostia; Recruiting

San Sebastian, Spain, 20014

Contact: Ioana Croitoru +34 943 00 72 46 ioana.croitoru@biodonostia.org

Principal Investigator: Javier Ruiz Martinez, MD

United Kingdom

Queen Mary University of London; Recruiting

London, Britain, United Kingdom, EC1M 6BQ

Contact: Cristina Simonet 44-02078823379 c.simonet@qmul.ac.uk

Principal Investigator: Cristina Simonet

Principal Investigator: Alastair Noyce

Newcastle University; Recruiting

Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE45PL

Contact: Victoria Foster +441912081197 victoria.foster@ncl.ac.uk

Principal Investigator: Nicola Pavese

Sub-Investigator: David Ledingham

Imperial College London; Recruiting

London, United Kingdom, W12 0NN

Contact: Raquel Lopes raquel.lopes@nhs.net

Principal Investigator: Yen Tai, MD

John Radcliffe Hospital Oxford and Oxford University; Recruiting

Oxford, United Kingdom, Oxford, OX3 9DU

Contact: Jamil Razzaque +441865223166 jamil.razzaque@ouh.nhs.uk

Principal Investigator: Michele Hu

Sponsors and Collaborators

Michael J. Fox Foundation for Parkinson's Research

Institute for Neurodegenerative Disorders

Investigators

• Principal Investigator: Kenneth L Marek, MD; Institute for Neurodegenerative Disorders
• Principal Investigator: Caroline Tanner, MD, PhD; University of California, San Francisco

More Information

• Responsible Party: Ken Marek, MD, Protocol Co- Principal Investigator, Institute for Neurodegenerative Disorders
• ClinicalTrials.gov Identifier: NCT04477785
• Other Study ID Numbers: PPMI-002
• First Posted: July 20, 2020
• Last Update Posted: December 14, 2023
• Last Verified: December 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ken Marek, MD, Institute for Neurodegenerative Disorders:

Parkinson; Bio-markers; Neurodegenerative disorder; Imaging; Prodromal; Genetics; At Risk; Loss of Smell

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases