BioFIND Study Overview
BioFIND is an observational clinical study designed to discover and verify biomarkers of Parkinson's disease (PD). The study was carried out at eight academic sites in the United States. Recruitment began in 2012 and closed in March 2015. BioFIND collected clinical data and biospecimens, including blood and cerebrospinal fluid, in 118 well-defined, moderately advanced people with PD and 88 control volunteers. Enrolled PD subjects met the United Kingdom PD Society Brain Bank (UKPDBB) clinical diagnostic criteria, modified to require all three classic motor signs of parkinsonism (i.e., bradykinesia, rigidity, and resting tremor), by history or examination, instead of just two signs (bradykinesia with either rigidity, resting tremor, or postural instability). PD duration, defined as time since motor symptom onset, in enrolled subjects ranged from 5 to 18 years. Subjects were excluded from the study if there was a history of cancer (except basal or squamous cell skin cancers) within 5 years preceding enrollment, autoimmune disorders, liver disease, or hematological disorders. Subjects with ablative brain surgery or DBS were excluded.
Total Participants (Cohort records that met the AMP PD minimum clinical data criteria):
AMP PD Designation:
Data from the BioFIND cohort is designated with the prefix “BF” in the AMP PD Portal. BioFIND data in the AMP PD portal includes: Demographics, family history, medication history, MDS-UPDRS, MoCA, WGS, blood transcriptomics.
Additional Study Information:
BioFIND Goals and Objectives
The primary objective is to identify a cohort of clinically typical PD with controls to provide a valuable resource for discovery and validation of promising biomarkers based on biofluids. This will facilitate development of biomarkers of:
- PD diagnosis
- Progression, by serving as a bridge to the longitudinal cohort of PPMI studies
- Clinical subtypes, by providing the most typical cohort which can serve as a standard for other PD cohorts, such as those with dementia or atypical features, and other Parkinson’s Plus disorders.
The specific aims to accomplish the primary objective are:
- Establish a bank of biofluids from a cross-sectional cohort of subject with “typical” PD
- Define control subjects for future biomarker studies
Study Specific Data Contribution
The following variables and associated data are specific to the BioFIND study and are available for analysis as part of AMP PD. These variables have not been harmonized across cohorts, but are relevant to Parkinson's Disease research:
|Biospecimen Analyses||SomaLogic (plasma)||Analysis of plasma proteins using an aptamer-based Somalogic platform|
Tables that Reference this Variable:
Data Type Information:
|Column Name||Data Type||Unique Values|
BioFIND Inclusion and Exclusion Criteria
PD patients must have characteristic disease signs (bradykinesia, rigidity, resting tremor, unilateral onset, good response to dopaminergic medications) and must have onset of disease between ages 50 to 75 with disease progression of five to 18 years duration from the onset of symptoms. They cannot have any other serious neurological or psychiatric disorder, a history of a major medical condition (e.g., cancer, liver disease), early onset autonomic symptoms, prior brain surgery (including for DBS placement), or be taking an investigational drug.
Healthy controls must be age 55 or older, and cannot have a family history of PD or any condition that the PD patients are excluded for.