Fox Investigation for New Discovery of Biomarkers

NCT01705327 | Completed

• 1 other identifier: BioFIND
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 7

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's; Biomarkers; Neurodegenerative disorder

Outcome Measures

Primary Outcomes (1)

• No primary outcome measure

  Two years

Study Arms (2)

Parkinson's Disease Subjects

Healthy Control Subjects

Eligibility Criteria

• Age: 55 Years - 93 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson's disease and healthy control subjects

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Has lower body predominant symptoms.
• Has supra-nuclear gaze palsy, CG sign, corticospinal track signs.
• 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.
• 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).

Sponsors & Collaborators

• Michael J. Fox Foundation for Parkinson's Research: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Rush University Medical Center

Chicago, Illinois, United States

Location

University of Chicago

Chicago, Illinois, United States

Location

University of Minnesota

Minneapolis, Minnesota, United States

Location

Columbia University Medical Center

New York, New York, United States

Location

Cornell University Medical Center

New York, New York, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Paslawski W, Svenningsson P. Elevated ApoE, ApoJ and lipoprotein-bound alpha-synuclein levels in cerebrospinal fluid from Parkinson's disease patients - Validation in the BioFIND cohort. Parkinsonism Relat Disord. 2023 Nov;116:105765. doi: 10.1016/j.parkreldis.2023.105765. Epub 2023 Jul 12.

  PMID: 37479568 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Parkinson Disease; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Un Jung Kang, MD

  University of Chicago

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 12, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 5, 2015

Record last verified: 2013-12

Locations

US (7)