The BioFIND study (Fox investigation for new discovery of biomarkers in parkinson’s disease): Design and methodology

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Neurology April 8, 2014 vol. 82 no. 10 Supplement P4.043
April 30, 2014
Poster Session IV
Movement Disorders: Parkinson's Disease Biomarkers
The BioFIND Study (Fox Investigation
For New Discovery Of Biomarkers In
Parkinson’s Disease): Design And
Methodology (P4.043)
Un Kang2,3, Roy Alcalay2,3, Jennifer Goldman6, Claire Henchcliffe9, Penelope Hogarth5, Paul Tuite7, Tao Xie1,
Mark Frasier4, Catherine Kopil4, Lona Vincent4, Nicole Willis4, Cindy Casaceli8 and Alice Rudolph8
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Neurology April 8, 2014 vol. 82 no. 10 Supplement P4.043
Abstract
ABSTRACT
OBJECTIVE:To describe the study design of BioFIND, an observational, cross­sectional, multi­center study of
biomarkers in moderate to advanced Parkinson’s disease (PD) and healthy control (HC)
subjects.BACKGROUND:PD­specific biomarkers will greatly aid clinicians’ ability to diagnose the disease and monitor
and/or predict its progression as well as provide a critical tool for therapeutic trials. However, prior studies are largely
limited by their sample size, inclusion of heterogeneous PD populations, or focus on de novo, unmedicated PD
patients. Thus, a platform for discovery and validation of biomarkers in well­characterized, moderate­to­advanced PD
is critically needed.DESIGN/METHODS: BioFIND aims to establish a repository of clinical data, blood, DNA, RNA,
and cerebrospinal fluid (CSF) samples from HCs and typical, moderate to advanced PD patients, whose clinical
diagnosis is strengthened by a minimum 5 year history and medication response.RESULTS:BioFIND will enroll 120
PD patients and 120 HCs over 2 years. Inclusion criteria for PD include classic motor features, dopaminergic
medication benefit, age 55­93 years, PD duration 5­18 years, and PD onset age 50­75 years. Primary exclusion
criteria include potential genetic factors (i.e., PD in first­degree relative), atypical parkinsonism or other neurological
disorders, or contraindications for lumbar puncture. Evaluations include demographics, motor and non­motor
questionnaires, and blood and CSF samples obtained in a practically defined “off medication” state. Presently, 25 PD
patients and 6 HCs have been enrolled. Biosamples will be available under the auspices of a program sponsored by
The Michael J. Fox Foundation (MJFF) with support from the National Institute of Neurological Disorders and Stroke
(NINDS).CONCLUSIONS:The BioFIND study will provide a valuable biospecimen resource for the discovery and
validation of novel biomarkers in typical, moderate to advanced PD. Promising markers can then be verified in
longitudinal cohorts and more heterogeneous PD subjects.Study Supported by:This study is sponsored by MJFF
with support from NINDS. We also thank supports from NIH CTSA (RNA).
Disclosure: Dr. Kang has received personal compensation for activities with Caremark Inc. as a medical advisory
board member. Dr. Kang has received research support from Allergan, Inc. Dr. Alcalay has received personal
compensation for activities with Genzyme. Dr. Alcalay has received research support from the National Institutes of
Health, Brookdale Foundation, Parkinson's Disease Foundation, Smart Foundation, and the Michael J Fox
Foundation. Dr. Goldman has received personal compensation for activities with American Academy of Neurology,
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2. Print ISSN: 0028­3878
Online ISSN: 1526­632X
Movement Disorder Society, Johns Hopkins Dystonia and Spasticity Practicum, and Teva Neuroscience. Dr. Goldman
has received research support from NIH/NINDS and the Parkinson's Disease Foundation. Dr. Henchcliffe has
received personal compensation for activities with GE Healthcare, GlaxoSmithKline, Inc., UCB Pharma, Impax, Teva
Neuroscience, US World Meds, Gerson Lehman Group, and MedIQ. Dr. Henchcliffe has received personal
compensation in an editorial capacity for Neurology Alert. Dr. Henchcliffe has received research support from Kaneka.
Dr. Hogarth has nothing to disclose. Dr. Paul Tuite has received research support from General Electric. Dr. Xie has
nothing to disclose. Dr. Frasier has nothing to disclose. Dr. Kopil has nothing to disclose. Dr. Vincent has nothing to
disclose. Dr. Willis has nothing to disclose. Dr. Casaceli has nothing to disclose. Dr. Rudolph has nothing to disclose.
Wednesday, April 30 2014, 7:30 am­11:00 am
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