Biomarkers Core

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Thanks to a major new grant, we are pleased to announce that as of November 2012 the Biomarker Study Core will be open to investigators from beyond the Harvard community. Please refer to our revised “Access” guidelines below for further details.

The Biomarkers Core aims to discover and validate biomarkers for neurodegenerative diseases.

The lack of biological markers is a critical roadblock in the development of disease-modifying therapeutics for Parkinson's and Alzheimer's disease. BSC is a biomarker incubator designed to overcome this roadblock.

The core is a longitudinal case-control study of over 2,000 individuals with early-stage PD, MCI/AD, and controls without neurologic disease. High-quality biosamples and high-resolution clinical phenotypes are tracked annually for several years. To minimize bias, controls are enrolled from the source population. Additionally, case and control samples are processed in parallel and quality-controlled. Hematological variables and processing steps are monitored. Biospecimens include plasma, serum, RNA, and whole blood, as well as DNA and immortalized cell lines, and ultimately, brain autopsy. Cerebrospinal fluid is longitudinally collected in a subset.

Progress

Enrollment continues at a steady pace of 20-30 subjects per month. More than 60,000 biological samples have been processed, quality-controlled, bar-coded and stored.

Sample Processing/Storage 

Blood samples from biomarker participants are transported at room temperature to the BSC laboratory for processing within 4 hours of blood draw. They are centrifuged and aliquotted into plasma, packed red blood cells, buffy coat and serum and stored at -80°. Samples collected in PAXgene tubes are transferred at room temperature to the laboratory and placed at -4° within 4 hours of the blood draw. RNA is processed within 3-5 days by the biospecimen manager using the PreAnalytix protocol. Cell lines are established and stored.

Clinical Data

Clinical data collected for every enrolled subject comes from physician exams measuring disease activity and severity, study staff interviews, and self-administered questionnaires and includes medical history, medication use, risk factor data, family history of neurologic diseases, co-morbidities, smoking history and caffeine intake. Also included are standardized tests measuring quality of life, depression, physical and cognitive function.

Access

A major aim of the program is to provide data and bio-specimens to other investigators engaged in biomarker discovery and development. We are accepting proposals from local, national and international investigators.

If you would like access to the program’s resources, the first step is to prepare a letter of intent. Please summarize your proposed project, including the hypothesis being tested and its significance for biomarkers, the data and/or samples required, and details of the proposed assay (if applicable), and send it to our Senior Project Manager This e-mail address is being protected from spam bots, you need JavaScript enabled to view it . Letters of intent are accepted at any time.

You are also welcome to contact Ana or either of the three program co-directors, to discuss your proposal.