Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
240 participants
OBSERVATIONAL
2012-10-31
2015-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Parkinson's Disease Subjects
No interventions assigned to this group
Healthy Control Subjects
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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.
* 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.
55 Years
93 Years
ALL
Yes
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Michael J. Fox Foundation for Parkinson's Research
OTHER
Responsible Party
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Principal Investigators
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Jennifer Goldman, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Roy Alcalay, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Claire Henchcliffe, MD, D. Phil
Role: PRINCIPAL_INVESTIGATOR
Well Cornell Medical Center
Tao Xie, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Paul Tuite, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota Medical Center
Un Jung Kang, MD
Role: STUDY_CHAIR
University of Chicago
Cindy Casaceli, MBA
Role: PRINCIPAL_INVESTIGATOR
Clinical Trial Coordinating Center, University of Rochester
Penelope Hogarth, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Samuel A. Frank, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Amy Amara, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
University of Minnesota
Minneapolis, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Cornell University Medical Center
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Countries
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Other Identifiers
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BioFIND
Identifier Type: -
Identifier Source: org_study_id
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