Clinical trial NCT01705327: Fox Investigation for New Discovery of Biomarkers
Official title: Fox Investigation for New Discovery of Biomarkers (BioFIND)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's
Biomarkers
Neurodegenerative disorder
Lead sponsor: Michael J. Fox Foundation for Parkinson's Research
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2012-10-12
Enrollment: 240
Sex: ALL
Minimum age (years): 55
Maximum age (years): 93
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's disease and healthy control subjects

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.

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 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.

Primary outcomes:
measure: No primary outcome measure
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Cornell University Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Rush University Medical Center
name: Jennifer Goldman, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Roy Alcalay, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Well Cornell Medical Center
name: Claire Henchcliffe, MD, D. Phil
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Tao Xie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota Medical Center
name: Paul Tuite, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Un Jung Kang, MD
role: STUDY_CHAIR
affiliation: Clinical Trial Coordinating Center, University of Rochester
name: Cindy Casaceli, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Penelope Hogarth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Samuel A. Frank, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Amy Amara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: