Fox Investigation for New Discovery of Biomarkers (BioFIND)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Michael J. Fox Foundation for Parkinson's Research
ClinicalTrials.gov Identifier:
NCT01705327
First received: October 9, 2012
Last updated: October 2, 2015
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
Study Completion Date: March 2015
Primary Completion Date: March 2015 (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   (Adult, Senior)
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

Locations
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
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

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: October 2, 2015
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
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 22, 2016