FNIH Biomarkers Consortium Launches a Project to Select Blood Tests that Detect Early Alzheimer's Disease

March 12, 2020  — The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium has launched a new project under its Neuroscience Steering Committee that will identify the best blood tests to aid in the early detection of Alzheimer’s disease. The “Plasma Aβ as a Predictor of Amyloid Positivity in Alzheimer's Disease” (Plasma Aβ) project will be the first study to directly compare multiple tests that track the buildup of beta amyloid, a protein in the brain that is associated with Alzheimer’s disease. The current methods of detection are costly and invasive, highlighting the need for reliable, patient-friendly tools to help identify people who may be in the earliest stages of Alzheimer’s disease.

Assessing the buildup of beta amyloid proteins in the brain can help physicians learn which patients are at risk of progressing to Alzheimer’s disease before the patients develop symptoms. Beta amyloid in the brain is currently assessed using either expensive PET scans or by testing of cerebrospinal fluid obtained through an invasive lumbar puncture. These procedures are required for clinical trials and contribute to the high cost of Alzheimer’s disease. Multiple assay developers (commercial and academic) are working to generate tools to measure Aβ in the blood. Several studies have shown that beta amyloid concentrations in the subjects’ plasma can be measured and reflect amyloid deposits in the brain if the methods are sensitive and specific enough.

This project will compare different blood test platforms to determine which ones are best at predicting the presence of beta amyloid in the brain. The project team—which includes experts from government, not-for-profit, academia and industry organizations—will assess and directly compare the function of six assay platforms (3 ligand binding assays and 3 mass spectrometry-based assays). They will then independently determine which are most specific and sensitive in predicting the presence of amyloid in the brain by comparing them to available PET imaging data from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) and other existing longitudinal observational studies. The analysis will be shared with the broader research community to help improve clinical trials and patient care for all clinical Alzheimer’s disease research.

For more information about the project, click here.

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

Private Partners:
AbbVie Inc.*
Alzheimer's Association ®*
Diagnostics Accelerator at Alzheimer's Drug Discovery Foundation*
Biogen MA Inc.*
Janssen Research & Development, LLC.*
Takeda Pharmaceutical Company*

Academic Partners:
Washington University School of Medicine in St. Louis
University of Gothenburg

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

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