PPMI 2.0 Clinical -Establishing a Deeply Phenotyped PD Cohort

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

Sponsors

Lead Sponsor: Michael J. Fox Foundation for Parkinson's Research

Collaborator: Institute for Neurodegenerative Disorders

Source Michael J. Fox Foundation for Parkinson's Research
Brief Summary

The Parkinson Progression Marker Initiative 2.0 (PPMI 2.0) 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 2.0 is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

Detailed Description

PPMI 2.0 is a broad program, expanding the goals of the original PPMI study (NCT01141023), that includes this PPMI 2.0 Clinical protocol, as well as the PPMI 2.0 Remote, PPMI 2.0 Digital Applications and PPMI 2.0 Online protocols. All participants in PPMI 2.0 will be asked to be enrolled in all PPMI 2.0 protocols, but depending on their method of recruitment, participants may be enrolled sequentially in varying order, as appropriate. PPMI 2.0 participants may also be asked to participate in additional PPMI 2.0 companion studies (as they are developed), which may only involve a subset of PPMI 2.0 participants based on their cohort designation and/or site location.

Overall Status Recruiting
Start Date 2020-07-01
Completion Date 2033-12-01
Primary Completion Date 2033-12-01
Study Type Observational
Primary Outcome
Measure Time Frame
Establish standardized protocols for acquisition, transfer & analysis of clinical, digital, imaging, biologic and genetic data that can be used in the PD research community. Baseline to 156 months
Comprehensive and uniformly acquired dataset Baseline to 156 months
Comparison between Rates of Change Study intervals ranging from 3 months to 156 months
Prevalence of measures of clinical, imaging and biomic outcomes in various subsets study intervals ranging from baseline to 156 months.
Establish the probability of phenoconversion to PD study intervals ranging from baseline to 156 months.
Enrollment 4500
Condition
Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: Parkinson Disease (PD) Subjects: - 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 with 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); OR either asymmetric resting tremor or asymmetric bradykinesia. - Hoehn and Yahr stage I or II at Baseline. - 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. - Confirmation that participant is eligible based on Screening DaTscan imaging. - Able to provide informed consent - Woman may not be pregnant, lactating or planning pregnancy during the study. ~Including a negative pregnancy test on day of Screening DaTscan imaging test prior to injection of DaTscan. Healthy Control (HC) Subjects: - Male or female age 30 years or older at Screening visit. - 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. - 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: Parkinson Disease (PD) Subjects: - Currently taking levodopa, dopamine agonists, MAO-B inhibitors (e.g., selegiline, rasagiline), 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 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: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit. - Current treatment with anticoagulants (e.g. coumadin, heparin, oral thrombin inhibitors) that might preclude safe completion of 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. Healthy Control (HC) Subjects: - Current or active clinically significant neurological disorder (in the opinion of the Investigator). - First degree relative with PD (parent, sibling, child). - Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator) - Received any of the follow drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit. - 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) Participants: - 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 a least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or 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: 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. - Confirmation that participant is eligible based on Screening DaTscan imaging. - Able to provide informed consent - Woman may not be pregnant, lactating or planning pregnancy during the study. ~Including 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: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit. - 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 rate genetic mutation (such as Parkin or Pink 1)) - 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); OR either asymmetric resting tremor or asymmetric bradykinesia. - Hoehn and Yahr stage I, II or III at Baseline. - Confirmation of causative SNCA or rare genetic mutation (such as Parkin or Pink 1) (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: 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. - Confirmation that participant is eligible based on Screening DaTscan imaging. - Able to provide informed consent - Woman may not be pregnant, lactating or planning pregnancy during the study. ~Including a negative pregnancy test on day of Screening DaTscan imaging test prior to injection DaTscan™. Exclusion Criteria: PD-SNCA or rate genetic mutation (such as Parkin or Pink 1)) - Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit. - 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. Prodromal Subjects: Inclusion Criteria For Screening: - 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 rate 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 - Woman may not be pregnant, lactating or planning pregnancy during the study. ~Including 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: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit. - 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.

Gender:

All

Minimum Age:

30 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Overall Contact

Last Name: Cari Rainville, BS

Phone: 877-525-7764

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
University of Alabama at Birmingham | Birmingham, Alabama, 35294, United States Recruiting PPMI Call Center 877-525-7764 Victor Sung, MD, PhD Sub-Investigator David Standaert, MD Principal Investigator
Barrow Neurological Institute | Phoenix, Arizona, 85013, United States Recruiting PPMI Call Center 877-525-7764 Holly Shill, MD Principal Investigator
Mayo Foundation for Medical Education and Research | Scottsdale, Arizona, 85259, United States Recruiting PPMI Call Center 877-525-7764 Charles Adler Principal Investigator
Banner Research Institute | Sun City, Arizona, 85351, United States Recruiting PPMI Call Center 877-525-7764 Sara Dhanani, MD Sub-Investigator David Shprecher Principal Investigator
University of California San Diego | La Jolla, California, 92093-0948, United States Recruiting PPMI Call Center 877-525-7764 Douglas Galasko, MD Principal Investigator
Keck School of Medicine of USC | Los Angeles, California, 90033, United States Recruiting PPMI Call Center 877-525-7764 Mark Lew Principal Investigator
University of California, San Francisco | San Francisco, California, 94115, United States Recruiting PPMI Call Center 877-525-7764 Caroline Tanner, MD Principal Investigator
University of Colorado Anschutz Medical Campus | Aurora, Colorado, 80045, United States Recruiting PPMI Call Center 877-525-7764 Maureen Leehey, MD Principal Investigator
Institute For Neurodegenerative Disorders | New Haven, Connecticut, 06510, United States Recruiting PPMI Call Center 877-525-7764 David Russell, MD Principal Investigator
Parkinson's Disease& Movement Disorder Center of Boca Raton | Boca Raton, Florida, 33486, United States Recruiting PPMI Call Center 877-525-7764 Stuart Isaacson, MD Principal Investigator
University of Florida | Gainesville, Florida, 32608, United States Recruiting PPMI Call Center 877-525-7764 Nikolaus McFarland Principal Investigator
University of South Florida | Tampa, Florida, 33606, United States Recruiting PPMI Call Center 877-525-7764 Robert Hauser, MD Principal Investigator
Emory University School of Medicine | Atlanta, Georgia, 30329, United States Recruiting PPMI Call Center 877-525-7764 Stewart A Factor, DO Principal Investigator
Northwestern University | Chicago, Illinois, 60611, United States Recruiting PPMI Call Center 877-525-7764 Tanya Simuni, MD Principal Investigator
University of Kansas Medical Center | Kansas City, Kansas, 66160, United States Recruiting PPMI Call Center 877-525-7764 Rajesh Pahwa, MD Principal Investigator
Johns Hopkins University | Baltimore, Maryland, 21287, United States Recruiting PPMI Call Center 877-525-7764 Emile Moukheiber, MD Principal Investigator
Boston University | Boston, Massachusetts, 02118, United States Recruiting PPMI Call Center 877-525-7764 Marie H. Saint-Hilaire, MD Principal Investigator
Massachusetts General Hospital | Boston, Massachusetts, 02446, United States Recruiting PPMI Call Center 877-525-7764 Aleksandar Videnovic, MD Principal Investigator
University of Michigan | Ann Arbor, Michigan, 48109, United States Recruiting PPMI Call Center 877-525-7764 Kelvin Chou Principal Investigator
Cleveland Clinic Lou Ruvo Center for Brain Health | Las Vegas, Nevada, 89106, United States Recruiting PPMI Call Center 877-525-7764 Zoltan Mari, MD Principal Investigator
Beth Israel Medical Center | New York, New York, 10003, United States Recruiting PPMI Call Center 877-525-7764 Susan Bressman, MD Principal Investigator
NYU Langone Health | New York, New York, 10017, United States Recruiting PPMI Call Center 877-525-7764 Un Kang Sub-Investigator Giulietta Riboldi Principal Investigator
Columbia University Medical Center | New York, New York, 10032, United States Active, not recruiting
University of Rochester | Rochester, New York, 14620, United States Recruiting PPMI Call Center 877-525-7764 Ruth Schneider, MD Principal Investigator
University of Cincinnati/Cincinnati Children's Hospital | Cincinnati, Ohio, 45219, United States Recruiting PPMI Call Center 877-525-7764 Alberto Espay, MD, MSC Principal Investigator
Cleveland Clinic | Cleveland, Ohio, 44195, United States Recruiting PPMI Call Center 877-525-7764 Hubert H. Fernandez, MD Principal Investigator
Oregon Health &Science University | Portland, Oregon, 97239, United States Recruiting PPMI Call Center 877-525-7764 Penelope Hogarth, MD Principal Investigator
University of Pennsylvania | Philadelphia, Pennsylvania, 19107, United States Recruiting PPMI Call Center 877-525-7764 Nabila Dahodwala, MD Principal Investigator
University of Pittsburgh | Pittsburgh, Pennsylvania, 15213, United States Recruiting PPMI Call Center 877-525-7764 Lana Chahine, MD Principal Investigator
Baylor College of Medicine | Houston, Texas, 77030, United States Recruiting PPMI Call Center 877-525-7764 Arjun Tarakad, MD Principal Investigator
Univ of Washington and VA Puget Sound Health Care System | Seattle, Washington, 98104, United States Recruiting PPMI Call Center 877-525-7764 Shu-Ching Hu, MD, PhD Principal Investigator
Innsbruck Medical University | Innsbruck, 6020, Austria Recruiting Dora Valent, PhD [email protected] Werner Poewe, MD Principal Investigator
The Ottawa Hospital - Civic Campus | Ottawa, Ontario, K1Y 4E9, Canada Recruiting PPMI Call Center 877-525-7764 Tiago Mestre Principal Investigator
Toronto Western Hospital | Toronto, Ontario, M5T 2S8, Canada Recruiting PPMI Call Center 877-525-7764 Connie Marras Principal Investigator
McGill University | Montréal, Quebec, H3A2B4, Canada Recruiting PPMI Call Center 877-525-7764 Ron Postuma Principal Investigator
Philipps-University of Marburg | Hessen, 35043, Germany Recruiting Elisabeth Sittig [email protected] Wolfgang Oertel Principal Investigator
Paracelsus-Elena Klinik | Kassel, 34128, Germany Recruiting Diana Willeke 49 561 6009 272 [email protected] Brit Mollenhauer, MD Principal Investigator
University of Luebeck | Luebeck, 23562, Germany Recruiting Norbert Bruggermann [email protected] Christine Klein, MD Principal Investigator
University of Tuebingen | Tuebingen, 72076, Germany Recruiting Ella Hilt +49 7072 298621 [email protected] Isabel Wurster, MD Sub-Investigator Kathrin Brockmann Principal Investigator
Foundation for Biomedical Research of the Academy of Athens | Athens, 11523, Greece Recruiting Christos Koros 00302107289405 [email protected] Leonidas Stefanis, MD, PhD Principal Investigator
Tel Aviv Sourasky Medical Center | Tel Aviv, 64239, Israel Recruiting Shira Paz, Bsc +97236973014 [email protected] Nir Giladi, MD Principal Investigator
University of Salerno | Salerno, 84131, Italy Recruiting Susan Ainscough, BA 39 340 519 2659 [email protected] Paolo Barone, MD, PhD Principal Investigator
Radboud University | Nijmegen, Gelderland, 6525 GC, Netherlands Recruiting Myrthe Burgler [email protected] Baastian Bloem Principal Investigator
Lagos College of Medicine, University of Lagos | Lagos, 121010, Nigeria Recruiting Oluwadamilola Ojo 2348033606414 [email protected] Njideka Okubadejo Principal Investigator
Hospital Clinic de Barcelona | Barcelona, 08036, Spain Recruiting Alicia Garrido, MD 34 932275785 [email protected] Eduardo Tolosa, MD Principal Investigator Maria Jose Marti Principal Investigator
Hospital Donostia | San Sebastian, 20014, Spain Recruiting Ioana Croitoru +34 943 00 72 46 [email protected] Javier Ruiz Martinez, MD Principal Investigator
Newcastle University | Newcastle Upon Tyne, Tyne And Wear, NE45PL, United Kingdom Recruiting Victoria Foster +441912081197 [email protected] Nicola Pavese Principal Investigator
Imperial College London | London, W12 0NN, United Kingdom Recruiting Raquel Lopes [email protected] Yen Tai, MD Principal Investigator
John Radcliffe Hospital Oxford and Oxford University | Oxford, Oxford, OX3 9DU, United Kingdom Recruiting Jamil Razzaque +441865223166 [email protected] Michele Hu Principal Investigator
Location Countries

Austria

Canada

Germany

Greece

Israel

Italy

Netherlands

Nigeria

Spain

United Kingdom

United States

Verification Date

2022-10-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Institute for Neurodegenerative Disorders

Investigator Full Name: Ken Marek, MD

Investigator Title: Protocol Co- Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Clinical Observation

Description: Up to 4500 participants will be followed clinically once identified, over the course of 5-8 years.

Acronym PPMI
Patient Data Undecided
Study Design Info

Observational Model: Case-Control

Time Perspective: Other

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