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Fox Investigation for New Discovery of Biomarkers (BioFIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01705327
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : October 5, 2015
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Michael J. Fox Foundation for Parkinson's Research

Study Description
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Brief Summary:
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 or disease
Parkinson's Disease

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Fox Investigation for New Discovery of Biomarkers (BioFIND)
Study Start Date : October 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Parkinson's Disease Subjects
Healthy Control Subjects


Outcome Measures
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Primary Outcome Measures :
  1. No primary outcome measure [ Time Frame: Two years ]

Biospecimen Retention:   Samples With DNA
Cerebrospinal Fluid (CSF), whole blood, DNA, plasma

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 93 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705327


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States
United States, New York
Columbia University Medical Center
New York, New York, United States
Cornell University Medical Center
New York, New York, United States
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Michael J. Fox Foundation for Parkinson's Research
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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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
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Responsible Party: Michael J. Fox Foundation for Parkinson's Research
ClinicalTrials.gov Identifier: NCT01705327    
Other Study ID Numbers: BioFIND
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: December 2013
Keywords provided by Michael J. Fox Foundation for Parkinson's Research:
Parkinson's
Biomarkers
Neurodegenerative disorder
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases