NEW YORK—The Alzheimer’s Drug Discovery Foundation (ADDF) has launched its new diagnostics accelerator initiative aimed at fast-tracking the development of digital tools for an early and accurate diagnosis of Alzheimer’s and related dementias. Since the accelerator program’s start in July 2018, funding commitments totaling $50 million have come from partners that include ADDF co-founder Leonard Lauder, Bill Gates, and philanthropists Jeff and MacKenzie Bezos, among others. The funding is earmarked for research aimed at capturing quantifiable biomarkers of Alzheimer’s disease (AD).
The ADDF has also announced the results of a first-of-its kind national multicenter study of more than 11,000 Medicare beneficiaries diagnosed with Alzheimer’s. The study, published April 2 in the Journal of the American Medical Association (JAMA), found that a form of brain imaging that detects AD-related “plaques” significantly influenced clinical management of patients with mild cognitive impairment and dementia.
Developing novel biomarkers allows physicians to specifically screen and diagnose patients, stage disease progression, monitor response to treatment, and improve the rigor and efficiency of clinical trials toward developing effective drugs for the prevention and treatment of the disease.
“The diagnostics accelerator brings together philanthropic capital with a venture investment mindset to advance bold new ideas for easier and more accurate diagnosis of Alzheimer’s disease and related dementias,” Lauder says.
In a “Gates Notes” post published April 2, Gates wrote, “It’s hard to overstate how important finding a reliable, affordable and easy-to-use diagnostic is for stopping Alzheimer’s. The use of advanced technology and digital tools, such as blood tests and mobile phone apps, can help empower doctors, patients and caregivers, ultimately leading to better outcomes.”
Dr. Howard Fillit, ADDF founding executive director and chief science officer, remarks: “The interest from the philanthropic as well as the scientific community has been tremendous. The ADDF is excited to expand its research support for the development of digital biomarkers that will augment traditional lab tests and imaging tools with creative and cost-effective approaches to collect, track and analyze patient data.”
Over 100 drugs are currently in clinical trials aimed at slowing or preventing AD, but these drugs are targeting many of the currently known contributors of the disease including increased inflammation, epigenetic changes, vascular problems and changes in metabolism. “We anticipate that a combination of treatments will be needed,” Fillit says, adding that a precision medicine approach to AD will allow physicians to treat the specific pathways that contribute to each individual patient’s disease.
Digital tools could also allow the remote capture of changes in a patient’s physical and mental status at various stages of Alzheimer’s disease, and information gathered can span from cognitive assessments to motor ability to sleep disruptions.
“Real-world evidence has the potential to add significant value to clinical trials, increasing patient engagement, enhancing monitoring and greatly improving treatment outcomes,” Fillit points out.
“In our first request for proposals, nearly 300 letters of intent proposing new diagnostic strategies from 30 countries on six continents were reviewed by the ADDF working closely with external scientific reviewers and the diagnostics accelerator joint steering committee,” he adds. “All data generated or used in each project should be made accessible to the research community through a digital data platform (under development).”
The ADDF’s first round of funding went to four recipients:
- Dr. Saliha Moussaoui of Amoneta Diagnostics SAS, France, was awarded up to $2 million to develop a rapid non-invasive diagnostic test to predict mild cognitive impairment and early Alzheimer’s disease.
- Dr. Kaj Blennow of the University of Gothenburg in Sweden was awarded $50,000 toward developing the first ultra-sensitive blood test for brain-specific tau.
- Dr. Tom MacGillivray of the University of Edinburgh in Scotland received $488,997 for a study employing a novel combination of retinal biomarkers capturing neurodegeneration and vasculature dysfunction often found in Alzheimer’s disease with advanced imaging analyses.
- Dr. Peter van Wijngaarden of the Centre for Eye Research Australia was awarded $420,321 for a study to test a simplified eye scan, which can detect amyloid in the retina prior to signs of cognitive decline. The team is developing a more portable and inexpensive prototype camera to establish whether this novel eye imaging technique can replace expensive PET imaging or invasive CSF tests for Alzheimer’s diagnosis and detect early signs of AD prior to signs of cognitive decline.
“Our near-term goal is to develop drugs for the treatment and prevention of Alzheimer’s,” Fillit says. “Because Alzheimer’s is a disease of aging and old age, delaying the onset by just five years would reduce the number of cases by 50 percent. The development of biomarkers is already enabling the beginnings of a precision medicine approach to Alzheimer’s.”