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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 was launched in 2007 with the aim of building a longitudinal biospecimen and data repository of subjects with neurodegenerative diseases (specifically AD, PD, and MCI) and healthy controls for biomarker discovery.  These resources are available to investigators with good ideas for developing or confirming biomarkers. 

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

The core is a longitudinal case-control study of over 2,100 individuals with early-stage PD, MCI/AD, and controls without neurologic disease. High-quality biospecimens and high-resolution clinical phenotypes are tracked annually for several years.


Progress

Enrollment continues at a steady pace of 20-30 subjects per month. More than 150,000 biological samples have been processed, quality-controlled, bar-coded and stored. The table below shows the number of subjects with biological and clinical data collected, by disease status as of 5/31/2014.  See below for a summary of how any investigator can apply for access to these samples and data.  (Modest access fees apply).
 

MEMORY DISORDER

SUBJECTS
Number  of Subjects withPlasma, PRBC, Serum, RNA, miRNA
1st visit 2nd visit 3rd visit 4th visit 5th visit
Alzheimer’s Disease(Probable/ Possible) 146 90 56 16 12
MCI(Amnestic/ Non-amnestic) 217 133 93 40 28
Impaired not MCI/ Other Dementias 270 180 138 87 45
TOTAL 633 403 287 143 85

MOVEMENT DISORDER

SUBJECTS
Number  of Subjects withPlasma, PRBC, Serum, RNA, miRNA
1st visit 2nd visit 3rd visit  4th visit  
Parkinson’s Disease  700 525 453  18  
Other NeurodegenerativeDisease 101 37 36    
TOTAL 801 562 489  18  
CONTROL SUBJECTS Number  of Subjects withPlasma, PRBC, Serum, RNA, miRNA
1st visit 2nd visit 3rd visit 4th visit 5th visit
TOTAL 821 522 402 166 66
ALL SUBJECTS 2255 1487 1178 327 151



 

 

 

 

 

 

 

 

 

 

 

 

 

 


Co-director Clemens Scherzer explaining the importance of biomarker discovery. For video click here.

Sample Processing/Storage 

Blood samples from biomarker participants are transported at room temperature to the Biomarkers Core 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 manual PAXgene blood RNA procedure. 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.