Biomarkers Consortium - Longitudinal Proteomic Changes in CSF from ADNI: Towards Better Defining the Trajectory of Prodromal and Early Alzheimer’s Disease

The lack of tools for early diagnosis and measurement of disease progression in Alzheimer’s disease (AD) continues to be a major hurdle in AD drug development. The current AD biomarkers (Aß, tTau, pTau) do not work in this context. To date, only a very small number of subjects have been identified who begin with normal values of these biomarkers, progress to abnormal values and are then established to have true AD. Finding a new marker could greatly impact progression and treatment monitoring.

The project addresses this need by extending the work on promising proteins identified in a previous Biomarkers Consortium project. The present study will focus on within-subject changes over time in individuals with mild cognitive impairment (MCI), AD and healthy controls. The longitudinal sample set has at least three CSF samples from each individual participant drawn over a three-year or greater period, as well as available clinical and imaging data. Success within this project could greatly improve progression and treatment monitoring in early Alzheimer’s disease patients. The data is now available to the public on the Laboratory of Neuroimaging (LONI). 


The goal of this project is to provide early validation for potential biomarker(s) that could be used as supportive endpoints in an MCI trial. To do so, the project will interrogate the most promising candidate biomarkers that provide significant within-subject changes over time using CSF samples from MCI and AD patients and healthy controls with three or more time points from the Alzheimer’s Disease Neuroimaging Initiative (ADNI).


Public-Sector Partners:
National Institute of Mental Health (NIMH)
National Institute on Aging (NIA)
U.S. Food and Drug Administration (FDA)

Private-Sector Partners:
Caprion Biosciences Inc.*
Genentech, a member of the Roche Group*
H. Lundbeck A/S*
Janssen Research & Development, LLC*
Takeda Pharmaceuticals USA Inc.*

Academic Partners:
University of Pennsylvania
Yale School of Medicine

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

FNIH Contact

Erin Rosenbaugh, Ph.D., P.M.P., Associate Scientific Program Manager, Neuroscience;