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

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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.

Additional Trial Information

Enrollment: 4,500 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Alabama

University of Alabama at Birmingham O'Neal Comprehensive Cancer Center at UAB

Birmingham, AL

Open and Accepting

Arizona

Barrow Neurological Institute

Phoenix, AZ

Open and Accepting

Mayo Clinic (Arizona)

Phoenix, AZ

Open and Accepting

Banner Research Institute

Sun City, AZ

Open and Accepting

California

Moores Cancer Center UC San Diego Health

La Jolla, CA

Open and Accepting

USC Norris Comprehensive Cancer Center University of Southern California

Los Angeles, CA

Open and Accepting

UCSF Medical Center at Mount Zion

San Francisco, CA

Open and Accepting

Colorado

University of Colorado Cancer Center Anschutz Cancer Pavilion

Aurora, CO

Open and Accepting

Connecticut

Yale Cancer Center Smilow Cancer Hospital at Yale-New Haven

New Haven, CT

Open and Accepting

Florida

Parkinson's Disease& Movement Disorder Center of Boca Raton

Boca Raton, FL

Open and Accepting

Shands Hospital University of Florida Health

Gainesville, FL

Open and Accepting

University of South Florida

Tampa, FL

Open and Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting

Illinois

Robert H. Lurie Comprehensive Cancer Center Northwestern University

Chicago, IL

Open and Accepting

Kansas

University of Kansas Cancer Center

Kansas City, KS

Open and Accepting

Maryland

Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medicine

Baltimore, MD

Open and Accepting

Massachusetts

Massachusetts General Hospital

Boston, MA

Open and Accepting

Michigan

University of Michigan Comprehensive Cancer Center Rogel Cancer Center

Ann Arbor, MI

Open and Accepting

Nevada

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, NV

Open and Accepting

New York

Mount Sinai Beth Israel Comprehensive Cancer Center West Side Campus

New York, NY

Open and Accepting

University of Rochester Medical Center James P. Wilmot Cancer Center

Rochester, NY

Open and Accepting

Ohio

University of Cincinnati College of Medicine

Cincinnati, OH

Open and Accepting

Cleveland Clinic Taussig Cancer Institute

Cleveland, OH

Open and Accepting

Oregon

Oregon Health and Science University OHSU Knight Cancer Institute

Portland, OR

Open and Accepting

Pennsylvania

Abramson Cancer Center University of Pennsylvania

Philadelphia, PA

Open and Accepting

Texas

Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center

Houston, TX

Open and Accepting

Washington

VA Puget Sound Health Care System

Seattle, WA

Open and Accepting
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