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  • BioFIND

BioFIND

  • Study Overview
  • Goals and Objectives
  • Study Specific Data Contribution
  • Inclusion and Exclusion Criteria
  • Study Protocol and Details

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 total for records that met the AMP PD minimum clinical data criteria):

213

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

BioFIND Database

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:

  1. PD diagnosis
  2. Progression, by serving as a bridge to the longitudinal cohort of PPMI studies
  3. 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: 

Assessment/Category Variable Definition
Biospecimen Analyses SomaLogic (plasma) Analysis of plasma proteins using an aptamer-based Somalogic platform

 

Tables that Reference this Variable:

  • Biospecimen_analyses_SomaLogic_plasma.csv
     

Data Type Information:

Column Name Data Type Unique Values
sample_type Enumeration Plasma

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.

Parkinson's Disease (PD) Subjects - Inclusion
Parkinson's Disease (PD) Subjects - Exclusion
Healthy Control (HC) Subjects - Inclusion
Healthy Control (HC) Subjects - Exclusion

Parkinson's Disease (PD) Subjects - Inclusion

  1. Subjects must have bradykinesia and rigidity
  2. Current or history of well documented resting tremor
  3. Unilateral onset or persistent asymmetry, but not strictly unilateral at the time of Enrollment
  4. A well established response to one or more dopaminergic agents and/or amantadine (the presence of levodopa induced dyskinesia is acceptable but not required)
  5. Subject has progressive PD of 5 to 18 years of duration from the onset of symptoms
  6. Male or female age of onset of PD 50 to 75 by history. Current ages would range from 55 to 93 based on #5 and #6 requirements
  7. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations
  8. Willing and able to comply with scheduled visits, required study procedures and laboratory tests
     

Parkinson's Disease (PD) Subjects - Exclusion

  1. Has other serious neurological disorders (clinically significant stroke, brain tumor, hydrocephalus, epilepsy, other neurodegenerative disorders, encephalitis, repeated head trauma)
  2. Had early severe autonomic involvement. Symptomatic orthostatic, hypotension or urinary incontinence within one year of onset of disease symptom
  3. Has a history of cancer (other than basal and squamous cell skin cancers), autoimmune disorder, liver disease, or hematologic disorders within the past 5 years
  4. Current treatment with anticoagulants (e.g., Coumadin, heparin) that might preclude safe completion of the lumbar puncture
  5. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia
  6. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation
  7. Use of investigational drugs or devices within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10). 
  8. Has lower body predominant symptoms
  9. Has supra-nuclear gaze palsy, cerebellar abnormalities, corticospinal track signs
  10. Has had brain surgery including pallidotomy, thalamotomy, subthalamotomy or deep brain stimulator (DBS) implantation
     

Healthy Control (HC) Subjects - Inclusion

  1. Male or female age 55 to 93 years or older at visit 1
  2. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations
  3. Willing and able to comply with scheduled visits, required study procedures and laboratory tests
     

Healthy Control (HC) Subjects - Exclusion

  1. Family history of PD in first degree relatives
  2. Has other serious neurological disorders (clinically significant stroke, brain tumor, hydrocephalus, epilepsy, other neurodegenerative disorders, encephalitis, repeated head trauma)
  3. Has a history of cancer (other than basal and squamous cell skin cancers), autoimmune disorder, liver disease, or hematologic disorders within the past 5 years
  4. Current treatment with anticoagulants (e.g., Coumadin, heparin) that might preclude safe completion of the lumbar puncture
  5. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia
  6. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation
  7. Use of investigational drugs or devices within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10)
  8. MoCA score <26

 

For further information regarding BioFIND inclusion/exclusion criteria, please contact: resources@michaeljfox.org

BioFIND Study Protocol

Full BioFIND Protocol

BioFIND Clinical Research Forms

 

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