The Alzheimer’s Drug Discovery Foundation (ADDF) announced six new investments totaling $6 million through its Diagnostics Accelerator initiative. These current awards include research for blood tests in various stages of development, with one close to becoming a viable diagnostic tool for early detection of Alzheimer’s disease. Other research efforts include the development of ocular and genetic tests that will aid in diagnosis and appropriate clinical trial design for intervention and disease monitoring for Alzheimer’s disease and related dementias.

Powered by a coalition of philanthropists, the Diagnostics Accelerator was created in July 2018 with funding commitments totaling nearly $50 million over three years from partners, including ADDF Co-Founder Leonard A. Lauder, Bill Gates, Jeff and MacKenzie Bezos, the Dolby family, the Charles and Helen Schwab Foundation, The Association for Frontotemporal Degeneration, among others, to develop novel biomarkers for the early detection of Alzheimer’s disease and related dementias. To date, funding has been awarded to 10 researchers worldwide, representing academia, biotech and a nonprofit consortium, with investments totaling nearly $10 million focused on developing blood and ocular biomarkers.

Our scientific and business due diligence teams chose these awards based on their promising research efforts and potential to bring simple and affordable diagnostic tests to physicians and patients. These awards represent a true collaboration among renown clinicians, who are directly involved with patients and understand the disease, scientists who are developing the tests, and diagnostics companies that understand the regulatory pathways – driving research and product development.

Our goal is to accelerate the development of early and more accurate diagnostic tests, as well as tests that can accelerate and improve the rigor of clinical drug development. Ultimately, these tests will represent the beginning of precision medicine for Alzheimer’s disease and related dementias.”

Dr. Howard Fillit, Founding Executive Director and Chief Science Officer of the Alzheimer’s Drug Discovery Foundation

The second round of research recipients include the following:

Blood tests in development – moving closer to clinical practice

Henrik Zetterberg, M.D., University of Gothenburg ($3,197,896), Sweden: Dr. Zetterberg and his lab are developing a test to detect Aβ40 and Aβ42 protein fragments in blood samples in a collaboration with Roche Diagnostics. Excess amounts of these proteins aggregate to form amyloid plaques, one of the hallmark pathological signs of Alzheimer’s disease. This blood test is one of the most advanced blood tests in development for the diagnosis for Alzheimer’s disease.

Rodney Pearlman, Ph.D., Bluefield Project to Cure FTD ($1.2 million), United States: Dr. Pearlman and the Bluefield team will evaluate blood neurofilament light chain (NfL) levels in people that carry an inherited form of frontotemporal degeneration (FTD), but do not yet show any disease symptoms. NfL is a protein in neurons that is released when the neurons are injured. The success of this test will support more efficient clinical trials, which could lead to effective treatments for FTD.

Douglas Galasko, M.D., University of California at San Diego ($375,000), United States: Neurofibrillary tangles, consisting of the tau protein, represent one of the two major pathological hallmarks of Alzheimer’s disease. This project aims to develop a test for Alzheimer’s disease by measuring tau and NfL, a protein indicative of neurodegeneration, in the blood. Dr. Galasko and his collaborators at ADx Neurosciences are developing these tests using a highly sensitive technology called single molecule immunoassay, which can detect proteins at very low concentrations in blood. These tests will pave the way for early disease diagnosis.

Genetic-based blood tests

Laura Ibanez, Ph.D., Washington University School of Medicine in St. Louis ($281,370), United States: This project measures gene products in the blood (called cell-free ribonucleic acid (cfRNA)) associated with Alzheimer’s disease. This type of test has revolutionized prenatal screening and cancer prognosis. A set of 25 gene products identified from a small number of Alzheimer’s patients will be assessed in a larger, well characterized population to create, optimize, and evaluate a predictive disease model. This research will enable the generation of a novel, non-invasive test that can predict disease onset. This in turn will help with correct diagnosis, appropriate clinical trial design for intervention and disease monitoring.

Samuil Umansky, M.D., Ph.D., DiamiR Biosciences ($492,000), United States: DiamiR Biosciences is developing a targeted diagnostic test to measure specific microRNAs, small molecules that regulate gene expression and reflect multiple cellular processes in blood. The molecules identified by DiamiR are associated with neurodegeneration and inflammation – two integral components of Alzheimer’s disease. They have evidence that these biomarkers can indicate Alzheimer’s disease prior to symptom onset.

Retinal imaging technology

Eliav Shaked, M.Sc., RetiSpec ($500,000), Canada: RetiSpec is harnessing retinal hyperspectral imaging to allow for the accurate, rapid and cost-effective identification of the signs of Alzheimer’s disease years before a patient presents clinical symptoms. In a pilot human study, the non-invasive retinal imaging technology was effective in detecting small changes in biomarkers associated with the pathological signs of Alzheimer’s, including the aggregation of soluble amyloid-beta. To validate the use of the technology in patients, RetiSpec is collaborating with the Toronto Memory Program, Canada’s largest Alzheimer’s clinical trial site, and The Joseph Sagol Neuroscience Center at Sheba Medical Center, Israel.