Building a Revolutionary, Individualized Approach to Treatment
This year, we have seen the continued rise of a new generation of biomarker-powered clinical trials, catalyzed by the ADDF. Tools like the Amyvid PET scan, which received seed funding from the ADDF, allow researchers to better track drugs’ effects and have paved the way for the approval of amyloid-targeting treatments like Kisunla and Leqmbi. As the ADDF’s portfolio of diverse biomarker programs continues to advance, this next phase of trial design will speed the approval of an arsenal of novel drugs. And because biomarkers also allow us to pinpoint the unique causes of each person’s Alzheimer’s, we will be able to tailor treatments specifically for every patient in a precision medicine approach.
The Year of the Blood Test
Advances in diagnostics development have exploded in recent months, driven by the ADDF’s Diagnostics Accelerator (DxA), a $100 million initiative dedicated to funding innovative blood tests, eye scans, and digital tools to diagnose Alzheimer’s. New data and announcements from ALZpath, C2N Diagnostics, and Fujirebio – all companies funded through the DxA – have come continuously throughout the year, building on momentum and bringing us closer to the day when blood tests could replace PET scans and CSF tests as a more accessible first line of defense in diagnosis, improving clinical trial enrollment, and ultimately speeding development of new treatments.
ALZpath kicked off 2024 with their blood test being featured in TIME and made available for use by physicians, building on the ADDF’s legacy of supporting innovative technologies in the diagnostics space. Over the summer, they followed this news with the announcement of a licensing agreement with Roche, and another with Beckman Coulter, that will lay the path for their pTau217 antibody to become a widely available blood test for Alzheimer's patients.
The DxA invested $7 million in C2N Diagnostics, its largest investment to date, building upon our longstanding partnership with C2N, which began in 2008 with our funding of the first blood test for Alzheimer’s, PrecivityAD. C2N will use this latest investment to develop a platform that will enable global access to its PrecivityAD2 test, which was shown to have over 90% accuracy in a study published in leading scientific journal JAMA. The accessibility of C2N’s blood tests will be further increased through a new partnership with Mayo Clinic Laboratories and an investment from Eisai, both announced this year.
Fujirebio filed their Lumipulse test for FDA regulatory approval, making them the first company ever to do so for an Alzheimer's blood test. If approved, the test is expected to become commercially available for Alzheimer’s patients in the U.S., making diagnosis more accessible. The company also announced a new partnership with Biogen and Beckman Coulter to identify and develop minimally invasive blood-based biomarkers to detect tau pathology in the brain.
Looking to the Future
As we continue to shape and lead the science, these blood tests will be complemented by retinal scans and digital biomarkers, using everyday technologies like tablets and smartphones to provide precise and timely diagnoses. Several promising diagnostic programs in development are outlined below.
Unlocking Alzheimer's Disease through Voice-Based Biomarkers
The ADDF established SpeechDx to create the largest single dataset of speech in Alzheimer’s and pre-Alzheimer’s patients. Speech is increasingly recognized as a potential predictor of cognitive decline and is easily measured with common smart devices. In 2024, SpeechDx enrolled over 1,000 participants who will be monitored for 3 years. This data will help researchers create algorithms to predict who is likely to develop Alzheimer’s disease and when the disease may occur.
CSF Test Gains National Recognition
The ADDF is supporting development of a biomarker test from Amprion, which detects misfolded alpha-synuclein proteins in the brain from just a few drops of cerebrospinal fluid (CSF) and will help physicians with early diagnosis of Alzheimer’s, Parkinson’s, and Lewy body dementia. Alpha-synuclein is gaining recognition as a key co-morbid pathology in Alzheimer’s disease, making it a promising biomarker. Amprion’s test was featured in the Wall Street Journal this year.