PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort
NCT ID: NCT04477785
Last Updated: 2025-10-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Total Enrollment
4500 participants
Study Classification
OBSERVATIONAL
Study Start Date
2020-07-01
Study Completion Date
2033-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression
NCT01141023
Parkinson Disease
COMPLETED
PHASE2
Parkinson Progression Marker Initiative Online (PPMI Online)
NCT05065060
Parkinson Disease
RECRUITING
Early Longitudinal Imaging in Parkinson's Progression Markers Initiative Using [¹⁸F] AV-133 and DaTscan™
NCT04507139
Parkinson Disease
ACTIVE_NOT_RECRUITING
Biomarkers in Parkinsonian Syndromes
NCT06501469
Parkinson Disease
Progressive Supranuclear Palsy
Multiple System Atrophy
+2 more
RECRUITING
AV133 Longitudinal Imaging Study in Patients With Early and Prdromal Parkinson's Disease
NCT06456684
Parkinson Disease
RECRUITING
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Parkinson Disease
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
CASE_CONTROL
Study Time Perspective
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Exclusion Criteria
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).
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).
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).
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.
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.
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).
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).
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).
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.
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.
Minimum Eligible Age
30 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institute for Neurodegenerative Disorders
OTHER
Sponsor Role
collaborator
Michael J. Fox Foundation for Parkinson's Research
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ken Marek, MD
Protocol Co- Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kenneth L Marek, MD
Role: PRINCIPAL_INVESTIGATOR
Institute for Neurodegenerative Disorders
Caroline Tanner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Site Status
RECRUITING
Barrow Neurological Institute
Phoenix, Arizona, United States
Site Status
RECRUITING
Mayo Foundation for Medical Education and Research
Scottsdale, Arizona, United States
Site Status
RECRUITING
Banner Research Institute
Sun City, Arizona, United States
Site Status
RECRUITING
University of California San Diego
La Jolla, California, United States
Site Status
RECRUITING
Keck School of Medicine of USC
Los Angeles, California, United States
Site Status
RECRUITING
University of California, San Francisco
San Francisco, California, United States
Site Status
RECRUITING
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Site Status
RECRUITING
Institute For Neurodegenerative Disorders
New Haven, Connecticut, United States
Site Status
RECRUITING
Parkinson's Disease& Movement Disorder Center of Boca Raton
Boca Raton, Florida, United States
Site Status
RECRUITING
University of Florida
Gainesville, Florida, United States
Site Status
RECRUITING
University of South Florida
Tampa, Florida, United States
Site Status
RECRUITING
Emory University School of Medicine
Atlanta, Georgia, United States
Site Status
RECRUITING
Northwestern University
Chicago, Illinois, United States
Site Status
RECRUITING
University of Kansas Medical Center
Kansas City, Kansas, United States
Site Status
RECRUITING
Johns Hopkins University
Baltimore, Maryland, United States
Site Status
RECRUITING
Boston University
Boston, Massachusetts, United States
Site Status
RECRUITING
Massachusetts General Hospital
Boston, Massachusetts, United States
Site Status
RECRUITING
University of Michigan
Ann Arbor, Michigan, United States
Site Status
RECRUITING
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States
Site Status
RECRUITING
Beth Israel Medical Center
New York, New York, United States
Site Status
RECRUITING
NYU Langone Health
New York, New York, United States
Site Status
RECRUITING
University of Rochester
Rochester, New York, United States
Site Status
RECRUITING
University of Cincinnati/Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Site Status
RECRUITING
Cleveland Clinic
Cleveland, Ohio, United States
Site Status
RECRUITING
Oregon Health &Science University
Portland, Oregon, United States
Site Status
RECRUITING
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Site Status
RECRUITING
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Site Status
RECRUITING
Baylor College of Medicine
Houston, Texas, United States
Site Status
RECRUITING
Univ of Washington and VA Puget Sound Health Care System
Seattle, Washington, United States
Site Status
RECRUITING
Innsbruck Medical University
Innsbruck, , Austria
Site Status
RECRUITING
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada
Site Status
RECRUITING
Toronto Western Hospital
Toronto, Ontario, Canada
Site Status
RECRUITING
McGill University
Montreal, Quebec, Canada
Site Status
RECRUITING
Philipps-University of Marburg
Hessen, , Germany
Site Status
RECRUITING
Paracelsus-Elena Klinik
Kassel, , Germany
Site Status
RECRUITING
University of Luebeck
Lübeck, , Germany
Site Status
RECRUITING
University of Tuebingen
Tübingen, , Germany
Site Status
RECRUITING
Foundation for Biomedical Research of the Academy of Athens
Athens, , Greece
Site Status
RECRUITING
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Site Status
RECRUITING
University of Salerno
Salerno, , Italy
Site Status
RECRUITING
Parkinson Research Clinic
Luxembourg, , Luxembourg
Site Status
RECRUITING
Radboud University
Nijmegen, Gelderland, Netherlands
Site Status
RECRUITING
Lagos College of Medicine, University of Lagos
Lagos, , Nigeria
Site Status
RECRUITING
Hospital Clinic de Barcelona
Barcelona, , Spain
Site Status
RECRUITING
Hospital Donostia
Donostia / San Sebastian, , Spain
Site Status
RECRUITING
Queen Mary University of London
London, Britain, United Kingdom
Site Status
RECRUITING
Newcastle University
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Site Status
RECRUITING
Imperial College London
London, , United Kingdom
Site Status
RECRUITING
John Radcliffe Hospital Oxford and Oxford University
Oxford, , United Kingdom
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
United States
Austria
Canada
Germany
Greece
Israel
Italy
Luxembourg
Netherlands
Nigeria
Spain
United Kingdom
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
Corrine Horlings
Role: primary
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
PPMI Call Center
Role: primary
877-525-7764
References
Explore related publications, articles, or registry entries linked to this study.
Pacheco Pachado M, Casas AI, Elbatreek MH, Nogales C, Guney E, Espay AJ, Schmidt HHHW. Re-Addressing Dementia by Network Medicine and Mechanism-Based Molecular Endotypes. J Alzheimers Dis. 2023;96(1):47-56. doi: 10.3233/JAD-230694.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PPMI-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Development of Imaging, Clinical and Biochemical Bio-Markers for Parkinson's Disease
NCT00315250
COMPLETED
PHASE2
Measuring Parkinson's Disease Progression
NCT03205956
COMPLETED
PHASE1
A Study of Neurophysiologic Changes in Individuals With Parkinson's Disease
NCT00117195
COMPLETED
Imaging and Genetic Biomarkers of Parkinson Disease (PD) Onset and Progression in High-risk Families
NCT00273351
COMPLETED
PHASE2
Study for the Early Diagnosis of Parkinson's Disease
NCT02283073
UNKNOWN
Imaging Biomarkers of Progression of Mobility Impairment in Parkinson Disease
NCT01106976
COMPLETED
Study of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Brain-first and Body-first PD
NCT07187843
RECRUITING
Fox Investigation for New Discovery of Biomarkers
NCT01705327
COMPLETED
Cohort Study to Identify Predictor Factors of Onset and Progression of Parkinson's Disease
NCT02305147
RECRUITING
The Personalized Parkinson Project (PPP)
NCT03364894
ACTIVE_NOT_RECRUITING
New Biomarkers in Parkinson's Disease
NCT05150158
UNKNOWN
Biomarkers of Risk of Parkinson Disease
NCT00775853
COMPLETED
Wearable Assessments in the Clinic and Home in PD
NCT03681015
COMPLETED
Unstructured Eye Tracking as a Diagnostic and Prognostic Biomarker in Parkinsonian Disorders
NCT05638477
UNKNOWN
NA
Identification of a Biomarker Predictive of Evolution of Parkinson Disease
NCT03230526
ACTIVE_NOT_RECRUITING
PHASE2
Analysis of Cortical Biomarkers for PD
NCT03645538
UNKNOWN
Measures of Motor Impairment in Early Parkinson's Disease
NCT00291265
COMPLETED
Parkinson's Disease Biomarker Program
NCT01767818
COMPLETED
Defining a PD-specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative Processes
NCT02749214
COMPLETED
Diagnostic Tools for Parkinson's Disease
NCT02403765
COMPLETED
Blood Biomarker in Early Parkinson's Disease
NCT03384797
COMPLETED
Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease
NCT03845634
COMPLETED
Imaging Studies of Cognitive Impairment in Parkinson s Disease
NCT01862744
COMPLETED
Research of Biomarkers in Parkinson Disease
NCT00465790
COMPLETED
Development of an Instrumented System to Measure Mobility in Parkinson's Disease
NCT01174758
COMPLETED