Biomarkers Consortium - Inflammatory Markers for Early Detection and Subtyping of Neurodegenerative and Mood Disorders

The identification and clinical validation of multi-component biosignatures for neurodegenerative and psychiatric diseases, as exemplified by Alzheimer’s Disease (AD) and Major Depressive Disorder (MDD) respectively, based on plasma tests or cerebral spinal fluid (CSF) sampling may allow subtyping of patients in order to match them with appropriate therapies and track treatment responses. It is hypothesized that aberrant immune function contributes to, or correlates with, the development and/or progression of a wide range of CNS disorders, and that measuring inflammatory markers in blood and/or CSF will yield multi-component biomarkers that will be useful in diagnosis and predicting treatment outcomes. Since no single analyte is likely to define reliable patient endophenotypes, it is necessary to develop a core panel of inflammation-related analytes to define specific biomarker fingerprints. Furthermore, it is likely that the lack of consensus and conflicting results regarding inflammation biomarkers in central nervous system (CNS) literature stems largely from small sample sizes, insufficiently sensitive assay technologies, a lack of technical assay validation, and of standardization of analyte panels examined, as well as differences in collection, handling and storage conditions for human samples.

Using technically well-validated and modern highly sensitive assays for biomarker quantification, as well as appropriately powered and harmonized sample collection and handling procedures across sites where human samples are obtained, this two-year Biomarkers Consortium project is expected to identify and validate plasma and/or CSF-based multi-marker inflammatory biosignatures in AD and MDD, which will aid in the diagnosis and sub-typing of patients. Furthermore, the information generated from these efforts will feed back into development of novel therapeutics, and could facilitate clinical studies where patients would be enrolled, in part, based on their biosignature.


  • Methods Development and Assay Validation – a) Identify analytes for inclusion in a broad panel of standard inflammation markers to be evaluated in human plasma and CSF. b) Assemble a set of samples from existing sources of AD and MDD patients and healthy controls for the purpose of assay validation c) Select and technically validate the assay platform(s)
  • Biosignature Development – a) Assemble a well-characterized sample set from existing sources from AD and MDD patients and healthy controls (training set) b) Accurately measure the levels of inflammatory markers in CSF and plasma in the training set c) Identify correlations of these measurements with each other and with clinical observations (biosignature development)

Results & Accomplishments

The project team has technically validated all of the assays and is awaiting a donation of samples to meet the first milestone of the project. For the Biosignature Development, the project team has identified the MDD plasma samples.


FNIH Web Announcement (April 26, 2018): The FNIH Biomarkers Consortium Launches Project to Improve Diagnosis and Treatment of Neurodegenerative and Psychiatric Diseases


Public-Sector Partners:
National Institute of Mental Health (NIMH)
National Institute on Aging (NIA)

Private-Sector Partners:
Alzheimer’s Drug Discovery Foundation*
Biogen MA Inc.*
Boehringer Ingelheim*
Genentech, a member of the Roche Group*
Janssen Research & Development, LLC*
Regeneron Pharmaceuticals Inc.*

*Provided financial or in-kind support for this program.

FNIH Contact

Wesley Horton, M.S., Scientific Project Manager, Neuroscience,