Bill Gate’s The Bill & Melinda Gates Foundation and Jeff Bezos’ Day One Fund have teamed to donate $15 million to the Diagnostics Accelerator, a project that is part of the Alzheimer’s Drug Discovery Foundation (ADDF). The Diagnostics Accelerator’s mission is fairly straightforward, although quite difficult—develop an easy and affordable test for Alzheimer’s disease.
On his blog, GatesNotes, Bill Gates outlines current advances in diagnosis Alzheimer’s, which is essentially via a spinal tap or a brain scan—invasive and expensive, respectively. And generally, people don’t look for diagnoses until they start showing symptoms. He writes, “It’s hard to overstate how important finding a reliable, affordable, and easy-to-use diagnostic is for stopping Alzheimer’s.”
One area of promise is a blood test. That was for quite some time not believed to be possible, but Randy Bateman, a researcher at Washington University in St. Louis, identified changes in Alzheimer’s patients’ blood in 2017 that has remained consistent and also been verified by other researchers. Gates writes, “There’s a good chance a blood test will start being used to recruit patients into Alzheimer’s drug trials within the next year or two.”
Another approach that Gates is excited about is linguistic. Rhoda Au heads neuropsychology for the Framingham Heart Study, which has tracked the health of one town’s residents for more than 70 years, including audio records of the patients.
Au and others are working on “digital markers,” that might identify changes in speech or writing habits that might act as early Alzheimer’s disease diagnostics.
Part of Gates’s blog is related to the ADDF’s Diagnostic Accelerator’s announcement today that it plans to fast-track digital tools for Alzheimer’s and related dementias. The Diagnostics Accelerator program itself was created in July 2018 with funding from co-founder Leonard Lauder, Gates, the Dolby family, and the Charles and Helen Schwab Foundation. Additional funds came from The Association for Frontotemporal Degeneration. Gates’ and Bezos’ funds bring the total program funding to almost $50 million.
The ADDF is announcing that funding for its Diagnostics Accelerator Digital Biomarker Initiative is now open to scientists and clinicians worldwide working in academic institutions, nonprofits, industry partnerships, and biotechnology companies, as well as new start-ups.
Funding priorities include portables, sensors, software, mobile and tablet apps, smart home systems, and virtual and augmented reality platforms.
Gates wrote, “We don’t know yet if voice analysis will work. It’s still early in the research process, and we don’t even know what changes in speech patterns we’re looking for yet. But I’m excited about a potential future where identifying your risk of developing Alzheimer’s is as simple as an app on your phone that you can instruct to listen for warning signs in your speech.”
The recent failure of Alzheimer’s drug aducanumab by Biogen and Tokyo-based Eisai underlines the difficulties of developing drugs to prevent and treat Alzheimer’s disease.
Howard Fillit, Founding Executive Director and Chief Science Officer of the ADDF wrote in a blog shortly after the failure was reported, “I had hope for this study as it had some promising results in the earlier phases of clinical development, showing that the drug ‘hit its target’ and was able to remove beta-amyloid from the brain of patients. It was also one of the first clinical trials to ensure that every patient participating had beta-amyloid plaques in their brains. The ADDF supported the first biomarker ever approved to diagnose Alzheimer’s—the beta-amyloid PET scan—and we continue to invest in these critical tools.”
He points out that, although it would seem obvious that if you were conducting clinical trials to remove plaques from the brain you would want to ensure the patients actually had plaques in the brain, “that hasn’t been the case until recently. Researchers have instead used tests that measure ‘downstream’ effects such as brain volumes on MRI, and cognitive outcomes like memory problems as criteria to enroll patients. Studies of patients after death have indicated that up to 30 percent of those enrolled in previous clinical trials didn’t in fact have plaques and possibly didn’t have Alzheimer’s at all.”
This clearly states just how important it is to develop a reliable, affordable and easy diagnostic test for Alzheimer’s, not only to potentially prevent the disease but to simply more reliably develop drugs to treat it.
Fillit wrote, “The Diagnostics Accelerator was created to address the lack of biomarkers to easily and more specifically screen and diagnose patients, stage disease progression, monitor response to treatment, and improve the rigor and efficiency of clinical trials—critical to the development of effective drugs for the prevention and treatment of Alzheimer’s.”
