FAQs

Study FAQ

PPMI is a landmark observational clinical study that aims to identify biomarkers of Parkinson’s disease (PD) progression by assessing multiple cohorts to develop the largest collection of clinical, imaging and biologic specimens ever created in the Parkinson’s community. PPMI data and specimens are made accessible through this Web site to academic and industry researchers to perform verification studies of PD biomarkers. The PPMI infrastructure is becoming a new model for biomarker research and will continue to add new cohorts.

PPMI is conducted in the United States, Europe, Israel, and Australia. The study is sponsored by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and is made possible by restricted donations to the Foundation from a consortium of Parkinson’s drug development stakeholders. PPMI is led by Principal Investigator Ken Marek, MD, President and Senior Scientist of the Institute for Neurodegenerative Disease in New Haven, Connecticut.

A biomarker can be any objectively measurable physical characteristic associated with the presence of disease (diagnostic marker), or any characteristic that changes over time in a way that can be tied to the progression of disease (progression marker). Examples from other health conditions include: Blood pressure, which is objectively and easily measured and, when high, acts as a diagnostic marker of potential heart disease; and, white blood cell count is a progression marker of leukemia. A count that rises to abnormal levels indicates that the condition is getting worse, while a count that returns to normal indicates improvement.

Study participants will be required to complete motor assessments, DaTSCAN, and MRI imaging, serum, plasma and urine collection, CSF collection, olfaction testing, DNA testing and neuropsychiatric/cognitive testing. All test data and specimens collected as part of this protocol will be submitted to the central study repositories and will be made available through this site.

Learn More About Accessing Data and Specimens

Investigators from academic institutions and industry organizations will be allowed to access the repository. Investigators are required to submit basic information about themselves for basic administrative review to ensure legitimacy. Upon approval, investigators will be given immediate access.

Apply for Access to PPMI Data

Request PPMI Specimens

PPMI data will be available to any researcher who is approved for access to the database. Because PPMI specimens are in limited supply, they will be reserved for biomarker verification studies, or studies to further validate lead marker candidates. PPMI samples cannot be used for discovery research, although other banks of samples exist for this purpose.

Learn more about PPMI Data and Specimens

The study needs people with and without Parkinson's disease. Volunteers — people recently diagnosed or with certain Parkinson’s risk factors — are critical partners in this research. To learn more and sign up for the study, click here.

Participants will be required to make four study visits in their first year, with visits twice a year thereafter. Each visit will include different tests, assessments and biologics sampling, including motor, neuropsychiatric and cognitive assessments; DatSCAN and MRI imaging; and, blood, cerebrospinal fluid (CSF), urine and DNA sampling.

View the Full Schedule of Activities for Enrolled Patients

Some people will participate in PPMI through its online platform. Others may be asked to complete some screening tests through the mail. And some volunteers do enroll in-person at a PPMI site. Because the study uses a standardized protocol, only certain medical centers can gather data and samples for PPMI.

Although MJFF is the study sponsor, PPMI is a pre-competitive collaboration that includes industry players, non-profit organizations, and private individuals. Consortia partners are contributing to PPMI through financial and in-kind support and are playing a lead role in providing feedback on study parameters through the Partner Scientific Advisory Board (PSAB). Through close interaction with the study, the PSAB is positioned to inform the selection of study assessments and review of potential markers that could be used to inform future clinical trial design.

Over 35 study partners have signed on to support PPMI. To learn more about opportunities for collaboration, email us at ppmi@michaeljfox.org.

In short, everyone acknowledges that the discovery of a biomarker would be transformative to the work being done in the field. However, biomarker development demands significant financial and intellectual resources and offers little short-term return on investment (compared to, say, a patentable new therapy). For individual academic or industry research groups, such a major undertaking does not offer the short-term rewards and long-term competitive advantage often used to assess business decisions to commit resources. In light of the urgent need for a Parkinson’s biomarker and the ambitious goal to meet that need through PPMI, it is fitting that multiple partners mobilize under the umbrella of a single streamlined and coordinated effort, sharing the expense, risk and, ultimately, the benefits of the research. MJFF is committed to spearheading efforts to accelerate the development of improved therapies for those living with Parkinson’s today. Given this aim, MJFF was uniquely poised and positioned to lead the push and marshal the necessary resources to make PPMI a reality.

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Data FAQ

PPMI data are available for download at https://www.ppmi-info.org/access-data-specimens/data. Further information about applying for access can be found below.

The study is sponsored by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and is made possible by restricted donations to the Foundation from a consortium of Parkinson’s drug development stakeholders. PPMI is led by Principal Investigator Ken Marek, MD, President and Senior Scientist of the Institute for Neurodegenerative Disease in New Haven, Connecticut.

PPMI was designed to provide all investigators in the scientific community with full, open access to study data. Investigators accessing PPMI data for the first time must complete the registration process, electronically sign the PPMI Data Use Agreement and undergo limited screening by the Data and Publications Committee (DPC), which is appointed by the study Steering Committee. The DPC reviews an investigator?s affiliation with a scientific or educational institution and/or the rationale for the data request. It is anticipated that most requests for access will be approved rapidly.

The SCREEN table contains a list of all consented subjects at any given time. The PARTICIPANT STATUS table contains a list of all enrolled subjects. The variable PATNO captures the subject-specific ID. If reports or analyses are desired based on enrolled subjects, the PARTICIPANT STATUS table should be merged by PATNO with any other tables of interest. All users should note that the number of enrolled subjects found in the PARTICIPANT STATUS table may not be exactly equal to the total number of enrolled subjects due to delays in submitted forms at a clinical site.

New entries into the clinical database are transferred nightly to the database. Each Sunday, a complete update to the database is conducted. Imaging data are integrated into the database separately, on a monthly basis.

The following clinical information and assessment results are included in the PPMI database:

  • Medical and family history (including demographics)
  • Physical examination
  • Neurological examination
  • Vital signs
  • MDS-UPDRS scores (including Part III and Hoehn & Yahr)
  • Modified Schwab & England ADL
  • UPSIT (olfactory testing)
  • Hopkins Verbal Learning Test
  • Benton Judgment of Line Orientation
  • Semantic fluency
  • Letter number sequencing
  • Symbol digit modalities
  • Montreal Cognitive Assessment (MoCA)
  • Epworth Sleepiness Scale
  • REM Sleep Behavior Questionnaire
  • Geriatric Depression Scale (GDS-15)
  • State-Trait Anxiety Inventory for Adults
  • QUIP
  • SCOPA-AUT
  • Current medical conditions review
  • Concomitant medication review
Imaging data will include:
  • DaTSCAN Imaging for PD subjects and controls subjects
  • Structural MRI Imaging
  • Diffusion Tensor Imaging (DTI) will be available from a subset of participants
Results from the analysis of the following will also be included:
  • Clinical laboratory evaluations (including CSF hemoglobin)
  • DNA sampling

In addition, the database will incorporate a running inventory of available samples collected from patient and control subjects. The following samples will be collected: serum, plasma, urine, cerebrospinal fluid, and skin biopsies.

A schedule of the frequency of these tests, assessments and sample collections is found in the Research Documents and SOPs section of this site.

All investigators who download data or utilize banked biospecimens must agree to the IP policies outlined in the Data Use Agreement and the Biospecimen Use Agreement. A core tenet underpinning PPMI is that new data generated by investigators using the study data or samples be made available to the research public as quickly as possible. To that end, investigators who download data agree to provide their new data back to the Data and Publications Committee to be incorporated into the PPMI study database. Similarly, investigators who receive access to banked samples will be required to submit data generated in their experiments to the Biospecimen Review Committee. Again, these results will be appropriately incorporated into the PPMI study database. By reserving the right to include investigators? results in the study database, it is hoped that new investigators will build upon the research findings generated by their colleagues. In addition to providing new findings back to the overseeing committees, investigators using PPMI data and specimens are required to provide summary information about their analyses in an Ongoing Analyses section of the Web site on an annual basis.

Specimens FAQ

PPMI specimens can be requested at /access-data-specimens/specimens. Further information about applying for specimens can be found here.

PPMI is conducted in the United States, Europe, Israel, and Australia. The study is sponsored by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and is made possible by restricted donations to the Foundation from a consortium of Parkinson’s drug development stakeholders. PPMI is led by Principal Investigator Ken Marek, MD, President and Senior Scientist of the Institute for Neurodegenerative Disease in New Haven, Connecticut.

Urine, DNA, serum, plasma, RNA, whole blood, cerebrospinal fluid, and skin biopsies are being collected. Investigators seeking to conduct verification studies must submit information about themselves and a Pre-Proposal describing the proposed use of the specimens for the study for review by the Biospecimen Review Committee. Select applicants will be invited to submit full proposals. Additional information about requesting PPMI specimens and what specimens are currently available can be found in the Request Specimens section of the website.

It is anticipated that the samples being collected in PPMI will be useful in biomarker studies, which will bolster scientists understanding of the natural history of early PD. Because these samples are a limited resource, they are primarily reserved for biomarker verification studies, such as protein and mRNA analyses. Investigators may request access to samples for such studies through an online application process. Click here for more information about Requesting Specimens or to review the Procedure and Guidelines to Access Banked Biospecimens.

The following clinical information and assessment results are included in the PPMI database:

  • Medical and family history (including demographics)
  • Physical examination
  • Neurological examination
  • Vital signs
  • MDS-UPDRS scores (including Part III and Hoehn & Yahr)
  • Modified Schwab & England ADL
  • UPSIT (olfactory testing)
  • Hopkins Verbal Learning Test
  • Benton Judgment of Line Orientation
  • Semantic fluency
  • Letter number sequencing
  • Symbol digit modalities
  • Montreal Cognitive Assessment (MoCA)
  • Epworth Sleepiness Scale
  • REM Sleep Behavior Questionnaire
  • Geriatric Depression Scale (GDS-15)
  • State-Trait Anxiety Inventory for Adults
  • QUIP
  • SCOPA-AUT
  • Current medical conditions review
  • Concomitant medication review
Imaging data will include:
  • DaTSCAN Imaging for PD subjects and controls subjects
  • Structural MRI Imaging
  • Diffusion Tensor Imaging (DTI) will be available from a subset of participants
Results from the analysis of the following will also be included:
  • Clinical laboratory evaluations (including CSF hemoglobin)
  • DNA sampling

In addition, the database will incorporate a running inventory of available samples collected from patient and control subjects. Samples of the following body fluids will be collected: serum, plasma, urine and cerebrospinal fluid.

A schedule of the frequency of these tests, assessments and sample collections is found in the Research Documents and SOPs section of this site.

All investigators who download data or utilize banked biospecimens must agree to the IP policies outlined in the Data Use Agreement and the Biospecimen Use Agreement. A core tenet underpinning PPMI is that new data generated by investigators using the study data or samples be made available to the research public as quickly as possible. To that end, investigators who download data agree to provide their new data back to the Data and Publications Committee to be incorporated into the PPMI study database. Similarly, investigators who receive access to banked samples will be required to submit data generated in their experiments to the Biospecimen Review Committee. Again, these results will be appropriately incorporated into the PPMI study database. By reserving the right to include investigators? results in the study database, it is hoped that new investigators will build upon the research findings generated by their colleagues. In addition to providing new findings back to the overseeing committees, investigators using PPMI data and specimens are required to provide summary information about their analyses in an Ongoing Analyses section of the Web site on an annual basis.