Fox Investigation for New Discovery of Biomarkers (BioFIND)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Michael J. Fox Foundation for Parkinson's Research
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael J. Fox Foundation for Parkinson's Research
ClinicalTrials.gov Identifier:
NCT01705327
First received: October 9, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

This is an observational, multi-center study to assess clinical features and biologic biomarkers in Parkinson's disease (PD) patients compared to healthy controls (HC). The primary objective of this study is to discover clinical and biologic markers of PD for use in clinical trials of disease-modifying therapies.


Condition
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Fox Investigation for New Discovery of Biomarkers (BioFIND)

Resource links provided by NLM:


Further study details as provided by Michael J. Fox Foundation for Parkinson's Research:

Primary Outcome Measures:
  • No primary outcome measure [ Time Frame: Two years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Cerebrospinal Fluid (CSF), whole blood, DNA, plasma


Estimated Enrollment: 240
Study Start Date: October 2012
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Parkinson's Disease Subjects
Healthy Control Subjects

Detailed Description:

BioFIND is a two-year observational clinical study designed to discover and verify biomarkers of Parkinson's disease (PD). BioFIND is collecting clinical data and biospecimens, including blood and cerebrospinal fluid (CSF), in a population of 120 well-defined, moderately advanced PD subjects and 120 healthy controls.

BioFIND will follow standardized data acquisition protocols to ensure that tests and assessments conducted at multiple sites can be pooled. Data and samples acquired from study participants will enable the development of a comprehensive Parkinson's database and biorepository, which will be available to the scientific community to conduct research on novel PD biomarkers.

  Eligibility

Ages Eligible for Study:   55 Years to 93 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Parkinson's disease and healthy control subjects

Criteria

Inclusion Criteria (PD Subjects):

  • Subjects must have bradykinesia and rigidity.
  • Current or history of well documented resting tremor.
  • Unilateral onset or persistent asymmetry.
  • A well established response to dopaminergic agents including the presence of levodopa induced dyskinesia for at least 3 years according to treating physician's judgment.
  • Subject has progressive PD of 5 to 18 years of duration from the onset of symptoms.
  • Male or female age of onset of PD 50 to 70 by history. Current ages would range from 55 to 93 based on #5 and #6 requirements.
  • Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
  • Willing and able to comply with scheduled visits, required study procedures and laboratory tests.

Exclusion Criteria (PD Subjects):

  • Family history of PD in first degree relatives.
  • Ashkenazi Jewish subject (defined as all 4 grandparents being Ashkenazi Jewish) will be excluded because of the high likelihood of genetic forms of PD (LRRK2) and GBA), unless these have been already excluded by genetic testing.
  • Has others serious neurological disorders (clinically significant stroke, brain tumor, hydrocephalus, epilepsy, other neurodegenerative disorders, encephalitis, repeated head trauma).
  • Has early severe autonomic involvement. Symptomatic orthostatic, hypotension or urinary incontinence within one year of onset of disease symptom.
  • Current treatment with anticoagulants (e.g., Coumadin, heparin) that might preclude safe completion of the lumbar puncture.
  • Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  • Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
  • 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).
  • Has lower body predominant symptoms.
  • Has supra-nuclear gaze palsy, CG sign, corticospinal track signs.

Inclusion Criteria (HC Subjects):

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

Exclusion Criteria (HC Subjects):

  • Family history of PD in first degree relatives.
  • Ashkenazi Jewish subject (defined as all 4 grandparents being Ashkenazi Jewish) will be excluded because of the high likelihood of genetic forms of PD (LRRK2) and GBA), unless these have been already excluded by genetic testing.
  • Has other serious neurological disorders (clinically significant stroke, brain tumor, hydrocephalus, epilepsy, other neurodegenerative disorders, encephalitis, repeated head trauma).
  • Has a history of cancer, autoimmune disorder, liver disease, or hematological disorders within the past 5 years.
  • Has early severe autonomic involvement: symptomatic orthostatic hypotension or urinary incontinence within one year of onset of disease symptom.
  • Current treatment with anticoagulants (e.g., Coumadin, heparin) that might preclude safe completion of the lumbar puncture.
  • Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  • Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
  • 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).
  • MoCA score <26.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705327

Contacts
Contact: Un Jung Kang, MD 212-305-1540 movdis@columbia.edu

Locations
United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Jeff Worrell, RN, BSN, MPMM, CCRP    205-996-4039    jworrell@uab.edu   
Principal Investigator: Amy Amara, MD, PhD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States
Contact: Jeana Jaglin    312-942-5003    jjaglin2@rush.edu   
Principal Investigator: Jennifer Goldman, MD         
University of Chicago Recruiting
Chicago, Illinois, United States
Contact: Joan Young, CCRP    773-834-1688    jyoung@neurology.bsd.uchicago.edu   
Principal Investigator: Tao Xie, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States
Contact: Christa Raszkowski    612-624-6778    Raszk001@umn.edu   
Principal Investigator: Paul Tuite, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States
Contact: Karina Sakanaka       ks2776@columbia.edu   
Principal Investigator: Roy Alcalay, MD         
Cornell University Medical Center Recruiting
New York, New York, United States
Contact: Mattson Ogg    212-746-2474    mao2026@med.cornell.edu   
Principal Investigator: Claire Henchcliffe, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Art Lenahan    503-494-1382    lenahan@ohsu.edu   
Contact: Alicia Portillo    503-494-1382    portillo@ohsu.edu   
Principal Investigator: Penelope Hogarth, MD         
Sponsors and Collaborators
Michael J. Fox Foundation for Parkinson's Research
Investigators
Principal Investigator: Jennifer Goldman, MD, MS Rush University Medical Center
Principal Investigator: Roy Alcalay, MD, MS Columbia University
Principal Investigator: Claire Henchcliffe, MD, D. Phil Well Cornell Medical Center
Principal Investigator: Tao Xie, MD, PhD University of Chicago
Principal Investigator: Paul Tuite, MD University of Minnesota Medical Center
Study Chair: Un Jung Kang, MD University of Chicago
Principal Investigator: Cindy Casaceli, MBA Clinical Trial Coordinating Center, University of Rochester
Principal Investigator: Penelope Hogarth, MD Oregon Health and Science University
Principal Investigator: Samuel A. Frank, MD Boston Medical Center
Principal Investigator: Amy Amara, MD, PhD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Michael J. Fox Foundation for Parkinson's Research
ClinicalTrials.gov Identifier: NCT01705327     History of Changes
Other Study ID Numbers: BioFIND
Study First Received: October 9, 2012
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Michael J. Fox Foundation for Parkinson's Research:
Parkinson's
Biomarkers
Neurodegenerative disorder

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on October 20, 2014