PDBP Study Overview
The National Institute of Neurological Disorders and Stroke (NINDS) Parkinson's Disease Biomarkers Program (PDBP) was developed to accelerate the discovery of promising new diagnostic and progression biomarkers for Parkinson's Disease.
The Parkinson's Disease Biomarkers Program (PDBP) is made up of researchers, patients, family members, and healthcare professionals who are dedicated to accelerating the pace of biomarkers research.
The PDBP supports basic, translational and clinical research through hypothesis testing, target and pathway discovery, biomarker development, and disease modeling through broadly sharing data and biospecimens developed under this program.
Total Participants (Cohort records that met the AMP PD minimum clinical data criteria):
AMP PD Designation:
Data from the PDBP cohort is designated with the prefix “PD” in the AMP PD Portal. PDBP data in the AMP PD portal includes: Demographics, family history, medication history, UPSIT, MDS-UPDRS, MoCA, WGS, blood transcriptomics
Additional Study Information:
PDBP Goals and Objectives
To overcome current roadblocks to better clinical trial design through improved assessment of PD progression across the disease spectrum, the PDBP will focus on building resources and supporting research that promotes the discovery of PD diagnostic and progression biomarkers.
In considering the landscape of current PD biomarker efforts across institutional, government and non-government agencies, the PDBP will facilitate research and the development of resources that bridge the gap between small pilot biomarker studies and validation studies of well replicated biomarker candidates.
In bridging this gap, the PDBP will support new and existing cohort studies that collect standardized longitudinal clinical data and biospecimens across all stages of PD, with the goal of coalescing this data into a single database that enables data to be shared broadly with the research community.
The PDBP will also support the development of analytical tools that will promote innovation around biomarker discovery. By recognizing the contribution of current biomarker studies and providing the resources necessary to successfully replicate promising biomarker candidates and promote innovative analytical solutions, the PDBP through its Data Management Resource, will work to unite and leverage these efforts to accelerate biomarker discovery for Parkinson's disease.
Study Specific Data Contribution
All variables and associated data provided by PDBP have been harmonized across the contributing cohorts.
PDBP Inclusion and Exclusion Criteria
All Participants - Inclusion
- Male or Female aged 21 years or older at screening
- Able to cooperate with consent procedures (or has appropriate surrogate as defined and approved per local IRB)
- Able to participate in study activities including all required clinical assessments and biological donations
- Participation would not lead to hardship or adverse health or mental health conditions
All Participants - Exclusion
- Condition that preclude the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or coagulopathy or thrombocytopenia
- Current treatment with anti-coagulants (e.g., Coumadin, heparin) that might preclude safe completion of the lumbar puncture
- Has a history of neuroleptic use or exposure
- Has a history of schizophrenia
- Otherwise unable to participate in biological specimen collection due to a medical condition or medication status (other than items listed above)
- Otherwise unable to participate in clinical assessments due to a medical condition or medication status (other than items listed above)
- Unable to participate in consent procedures
- Use of investigational drugs or devices within 60 days prior to baseline visit (dietary supplements such as Coenzyme Q10, for example, are not exclusionary)
Case Specific Criteria
- Clinically diagnosed with Parkinson's Disease
- Clinical Diagnosis uncertain at time of enrollment
Control Specific Criteria
- Has a current or clinically significant neurological disorder in the opinion of the investigator
- Family history of Neurodegenerative disease in a first degree relative or second degree blood relative
For further information regarding PDBP inclusion/exclusion criteria, please contact: PDBP-OPS@mail.nih.gov