Fox Investigation for New Discovery of Biomarkers

Parkinson's Disease Clinical Trial

— BioFIND  

Official title:

Fox Investigation for New Discovery of Biomarkers (BioFIND)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705327
• Other study ID #: BioFIND
• Status: Completed
• Phase: N/A
• First received: October 9, 2012
• Last updated: October 2, 2015
• Start date: October 2012
• Est. completion date: March 2015

Study information

• Verified date: December 2013
• Source: Michael J. Fox Foundation for Parkinson's Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 93 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Michael J. Fox Foundation for Parkinson's Research	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No primary outcome measure		Two years	No