Purpose

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.

Condition

Eligibility

Eligible Ages
Over 30 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
Clinical Observation Up to 4500 participants will be followed clinically once identified, over the course of 5-8 years.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Courtney Blair, MA
205-975-2894
courtneyblair@uabmc.edu

More Details

Status
Recruiting
Sponsor
Michael J. Fox Foundation for Parkinson's Research

Study Contact

Cari Rainville, BS
2032159611
crainville@indd.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.