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

October 9, 2012
December 17, 2013
October 2012
October 2014   (final data collection date for primary outcome measure)
No primary outcome measure [ Time Frame: Two years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01705327 on ClinicalTrials.gov Archive Site
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Fox Investigation for New Discovery of Biomarkers
Fox Investigation for New Discovery of Biomarkers (BioFIND)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

Parkinson's disease and healthy control subjects

Parkinson's Disease
Not Provided
  • Parkinson's Disease Subjects
  • Healthy Control Subjects
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
Not Provided
October 2014   (final data collection date for primary outcome measure)

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.
Both
55 Years to 93 Years
Yes
Contact: Un Jung Kang, MD 212-305-1540 movdis@columbia.edu
United States
 
NCT01705327
BioFIND
No
Michael J. Fox Foundation for Parkinson's Research
Michael J. Fox Foundation for Parkinson's Research
National Institute of Neurological Disorders and Stroke (NINDS)
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
Michael J. Fox Foundation for Parkinson's Research
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP