Objective/Rationale:
A biochemical biomarker is a chemical in bodily fluids (e.g. blood, cerebrospinal fluid, urine, etc.) that may be helpful in detecting Parkinson’s disease (PD) or in measuring the progression of PD. Several biochemical biomarkers have been identified in previous studies but the methods to detect these markers utilized crude techniques and the sensitivity must be improved if they ever will be used in a routine laboratory setting. MJFF is collaborating with several specialized companies to improve the technologies of biochemical biomarker detection to make them more reproducible across laboratories.
Project Description:
Alpha-synuclein and DJ-1 are proteins that appear to change in people with Parkinson’s disease. The current methods of detecting alpha-synuclein and DJ-1 in blood and cerebrospinal fluid require specialized tools that are only available to a few laboratories throughout the world and even those laboratories utilize different protocols for detection. MJFF will work with Epitomics, a company that specializes in making antibodies, to generate high quality, consistently performing and renewable antibodies so that all researchers can utilize the same antibody tools when testing alpha-synuclein levels in body fluids.
MJFF will also collaborate with the Antibodies Products group at Covance, Inc. to transfer alpha-synuclein and DJ-1 kits that exist in academic laboratories to a setting where the kit can be carried out in a rigorous, high throughput fashion. Covance will also improve the sensitivity of the kit so that it may detect very small amounts of the two biomarkers in bodily fluids.
A third project will collect body fluids from healthy volunteers and store the fluids to use as a resource for testing and optimizing biochemical biomarkers. Parexel, a company specializing in clinical patient studies, will collect and process serum, plasma and cerebrospinal fluid from 12 healthy volunteers at 11 time points over the course of a 26 hour visit. The biospecimens will be stored frozen at a repository and made available to researchers as a resource to determine whether certain biochemical biomarkers fluctuate over the course of a 24 hour period (a diurnal fluctuation). The results will inform researchers about the variability of the biomarker in healthy volunteers and guide researchers towards the most optimal time of day to collect the biomarker fluid (e.g. morning, evening, after meal, etc).
Relevance to Diagnosis/Treatment of Parkinson’s Disease:
Biomarkers are often used to stratify patients for treatment or detect the effectiveness of a test drug in clinical trials. These studies will help develop rigorous and consistent methodologies for biomarker detection so that many different researchers from all over the world will be able to use these sensitive methodologies.
Anticipated Outcome:
We anticipate there will be a standardized “kit” that Covance will offer as a service for the detection of alpha-synuclein and DJ-1 for Parkinson’s disease researchers. This service will allow investigators to compare the results of studies to each other since the kits will be more uniform and carried out in one laboratory.
We also anticipate that the banked biospecimens will be a valuable resource for existing researchers who have identified a novel biochemical biomarker and would like to test the variability of these biomarkers in the same individual over a 24 hour period.