Diagnostics Accelerator Award Recipients

The Diagnostics Accelerator has funded investigators around the world who are developing and testing innovative biomarkers for Alzheimer’s and related dementias.

Research funded to date focuses on a range of methods and targets including blood tests in various stages of development, with one close to becoming a viable diagnostic tool for early detection of Alzheimer’s. Other research efforts include development of eye scans and genetic tests that will aid in Alzheimer’s diagnosis and clinical trial design.

These awards focus on 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.

University of Washington

Cecilia Lee, MD, MS

  • Eye

Dr. Lee and her team aim to comprehensively evaluate multiple ophthalmic (eye-related) biomarkers and apply an algorithm to understand the contribution of each biomarker for an Alzheimer’s disease diagnosis using noninvasive novel imaging modalities combined with deep learning analysis. By simultaneously evaluating many promising biomarkers in patients who are cognitively normal compared to those who have mild cognitive impairment or early Alzheimer’s disease, they seek to identify a panel of biomarker tests that can be used to diagnose early Alzheimer’s disease and/or predict Alzheimer’s development.

Christie Sheehy, PhD

C. Light Technologies, Inc.

Christie Sheehy, PhD

  • Eye

Dr. Sheehy and her team aim to use a device developed by C. Light Technologies called the tracking scanning laser ophthalmoscope (TSLO) device to record involuntary eye movements in patients with mild cognitive impairment (MCI) and use these movements as a biomarker for the disease. The tracking of these eye motions will provide granular disease progression mapping/feedback, with the end goal of early detection for MCI. The team will be working in collaboration with the Memory and Aging Center at the University of California, San Francisco.

Quanterix Corporation

David Wilson, PhD

  • Blood

Dr. Wilson’s team, in collaboration with Dr. Charlotte Teunissen of Amsterdam UMC, is using Quanterix’s Simoa technology to digitally measure biomarkers in the blood at lower levels than previously possible. This technology can count single molecules, lending it unprecedented sensitivity, which enables it to measure biomarkers that can otherwise be missed in the blood because they are “drowned out” by other, more abundant proteins. Simoa technology can also combine measurements for several biomarker proteins into a single test. This project will combine the most promising blood plasma biomarkers into a test for early Alzheimer’s detection.

GAP Innovations, PBC

Diana Kerwin, MD, CPI

  • Blood

Dr. Kerwin and her team at GAP PBC are initiating a clinical study to organize the first systemic, well-characterized sampling and data collection effort focused on blood-based and digital biomarkers. This will be used for the development of a rigorous “pre-screening” data analytics program to be used in future clinical trials to save substantial time and money. These samples and associated data will be available for purchase by members of the research community to further research into blood biomarkers. In addition, the data collected will provide insight in how to refine recruitment and screening processes, reducing recruitment time for clinical trials.

Eliav Shaked, MSc

RetiSpec

Eliav Shaked, MSc

  • Eye

RetiSpec is testing the ability of an eye scanning technology, called hyperspectral imaging, to detect small changes in beta amyloid and other biomarkers in the retina associated with the signs and symptoms of Alzheimer’s disease. 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 in Israel to validate the test. If successful, this test would allow for accurate, rapid, and cost-effective diagnosis of Alzheimer’s disease years before a patient shows clinical symptoms.

Foundation for the National Institutes of Health

Foundation for the National Institutes of Health

Foundation for the National Institutes of Health

  • Blood

The Foundation for the National Institutes of Health’s Biomarkers Consortium project, Plasma Abeta as a Predictor of Amyloid Positivity in Alzheimer’s Disease, is assessing the functionality of six top performing blood tests that measure amyloid levels in plasma. Amyloid is the protein that clumps into plaques in the brains of Alzheimer’s patients. The current gold standard for detecting these plaques is either expensive PET imaging or invasive spinal fluid taps. A minimally invasive, high-quality blood test would be easier for patients and could speed up the process of enrolling patients in appropriate Alzheimer’s disease clinical trials.

MindImmune

Frank Menniti, PhD

  • Blood

MindImmune is developing a new therapeutic approach to block certain immune cells from crossing from the blood into the brain, where they attack the brain’s synapses, damaging the means through which the brain’s synapses communicate. The ADDF’s investment supports development of a contrast agent, which acts as a kind of dye that is injected into the blood to help with imaging, allowing researchers to "see" immune cell infiltration into the brain. This may serve as a new diagnostic for the disease and as an aid to the development of MindImmune's new therapeutic approach.

Ioannis Tarnanas, PhD

Altoida, Inc.

Ioannis Tarnanas, PhD

  • Digital

Dr. Tarnanas and his team aim to test a novel mobile phone and tablet-based digital biomarker platform that evaluates cognition through a user-friendly exercise that simulates tasks associated with activities of daily living. They propose to show the usefulness of this platform for detecting individuals at high risk for Alzheimer’s disease, namely in subjective cognitive decline (SCD) and mild cognitive impairment (MCI) subjects, allowing them to track disease progression in these patients.

Optina

Jean-Philippe Sylvestre, PhD

  • Eye

Dr. Sylvestre and his team aim to validate the ability of Optina’s proprietary platform to detect the brain’s amyloid status by imaging of the retina, the only optically accessible part of the central nervous system. The goal is to eventually replace expensive amyloid PET scanning with a more accessible and easier-to-administer retinal scan that can accurately detect this key hallmark of Alzheimer’s disease.

Digital Medicine Society (DiMe)

Jennifer Goldsack, MChem, MA, MBA, OLY

  • Digital

This project is a collaboration between Alzheimer’s experts from pharma, biotech, health tech, and non-profits to identify a set of standardized, digital clinical measures that can be used in the development of therapies for Alzheimer’s disease and related dementias. The measures will bring consensus, consistency, and effectiveness to drug development and clinical care. By demonstrating global meaningful aspects of health for Alzheimer’s patients, mapping technology capabilities to what matters most to patients, and building consensus around a priority set of core measures, the team will deliver the field’s defining digital clinical core measure set for Alzheimer’s and related dementias drug development.

Neurotrack Technologies, Inc.

Jennifer Myers

  • Digital

Neurotrack has developed a comprehensive platform for the assessment of cognitive health in aging populations. The assessments are designed so they can be taken on smartphones, tablets, or computers, making it possible for them to be taken at home or in a doctor’s office. The assessments collect multiple types of data including eye tracking, voice, and touch feedback to measure function in a number of cognitive domains. This project aims to demonstrate the ability of the cognitive assessment platform to distinguish between people with normal function, mild cognitive impairment, and Alzheimer’s disease, as well as to examine the relationship between performance on the tests and biomarkers of the disease.

Boston Children's Hospital

Judith Steen, PhD

  • Blood

Dr. Steen and her team are developing a blood test to measure levels of two proteins, called tau and TDP-43, biomarkers that can signal early changes in the brains of people who will go on to develop FTD. There are no tests currently to distinguish between tau and TDP-43 pathology, a distinction which is needed to enroll FTD patients in the right clinical trials. These blood tests would provide an efficient, minimally invasive way to differentiate FTD subtypes and provide clinicians with critically needed tools to follow individual treatment response.

Laura Ibanez, PhD

Washington University School of Medicine

Laura Ibanez, PhD

  • Blood

Dr. Ibanez and her team have identified 25 genetic molecules, called cell-free ribonucleic acid (cfRNA, a type of RNA found outside of cells) that are associated with Alzheimer’s disease and can be measured in the blood. The cfRNA were identified from a small number of Alzheimer’s patients and will now be assessed in a larger, well characterized patient population to create, optimize, and evaluate a tool to predict Alzheimer’s disease onset. This test will help with earlier and accurate diagnosis, inform clinical trial design, and improve disease monitoring.

Leyla Anderson, MD, PhD, D(ABMLI)

NeuroVision Imaging

Leyla Anderson, MD, PhD, D(ABMLI)

  • Blood

Dr. Anderson and her team have discovered proteins and metabolites in the blood that have the potential to provide an early diagnosis of Alzheimer's disease. They aim to determine the diagnostic accuracy of these biomarkers with samples from the Australian Imaging and Biomarker Lifestyle study of ageing (AIBL), which is one of the largest studies of Alzheimer's disease in the world. They hope the information gained will be a significant step forward in the development of a blood test for Alzheimer’s, which will act as a screening tool for early detection of the disease before symptoms are obvious.

Biological Dynamics, Inc

Michael Catania, PhD

  • Blood

Cantania and his colleagues at Biological Dynamics have developed the Verita™ system, which enables the automated capture and analysis of proteins on the surface of exosomes. Exosomes are small bubbles released from cells (including neurons) that contain many types of biomarkers, including those that reflect pathological changes in the brain which indicate Alzheimer’s disease. Detecting several exosome-based biomarkers has the potential to improve detection and diagnosis of Alzheimer’s, as well as enhancing drug discovery applications.

University of Utah

Qinwen Mao, MD, PhD

  • Blood

This study is aiming to develop a blood test that can measure pathologic levels of certain forms of TDP-43, a binding protein that commonly accumulates in the brains of people with various neurodegenerative diseases. The study will assess the ability of a sensitive and specific TDP-43 biomarker to distinguish between different forms of frontotemporal degeneration, Alzheimer’s disease and normal aging.

Boston University

Rhoda Au, PhD

  • Digital

Dr. Au and her team aim to collect data on Alzheimer’s disease related characteristics, such as cognition, gait, balance, mood and depression, in a digital format using smart phones and tablets. This data will be collected from subjects participating in the Framingham Heart Study and will be used to create digital profiles that can differentiate between people with stable cognition, cognitive decline, and dementia. Gathering digital data on Alzheimer’s characteristics will enable low-cost, continuous and accurate remote monitoring of large populations over time, eventually paving the way for diagnosis and treatment prior to clinical manifestation of the disease.

Rodney Pearlman, MD

Bluefield Project to Cure FTD

Rodney Pearlman, MD

  • Blood

Dr. Pearlman of the Bluefield Project is leading this program along with Dr. Adam Boxer to evaluate blood levels of a protein called NfL (neurofilament light chain) in people who carry an inherited form of dementia called frontotemporal degeneration (FTD) who do not yet show symptoms of the disease. The success of this project will support more efficient clinical trials, which could lead to effective treatments for FTD. This study will have value beyond FTD because NfL has been identified as an important biomarker for other neurodegenerative diseases such as Alzheimer’s disease, multiple sclerosis, Parkinson’s disease and amyotropic lateral sclerosis (ALS).

Amprion, Inc

Russell Lebovitz, MD, PhD

  • Blood

Dr. Lebovitz and his team aim to validate a highly sensitive and specific diagnostic for Alzheimer’s disease and other dementias associated with misfolded protein aggregates. Their technology platform detects soluble protein aggregates directly with high sensitivity and selectivity, identifying what is widely believed to be the critical molecular pathogenic event directly. This offers the opportunity to develop a sensitive diagnostic for Alzheimer’s disease that is suitable for routine clinical screening and able to diagnose the disease prior to the onset of significant cognitive symptoms.

Samuil Umansky, MD, PhD

DiamiR Biosciences

Samuil Umansky, MD, PhD

  • Blood

Dr. Umansky and colleagues have identified specific microRNAs – molecules that are associated with two integral components of Alzheimer’s disease, neuron degeneration and inflammation. There is evidence that these microRNAs can serve as biomarkers that signal Alzheimer’s disease prior to symptom onset. The team is developing a diagnostic test to measure these microRNAs in blood samples.

Sidney Strickland, PhD

Rockefeller University

Sidney Strickland, PhD

  • Blood

Dr. Strickland and his team are developing a blood test to detect changes in a protein called high molecular weight kininogen — a biomarker showing impairment in the brain’s blood vessels. Vascular impairments are common in people with Alzheimer’s disease and are thought to contribute to cognitive decline. This research will determine how common these impairments are, when they appear in the course of the disease, and if the changes correlate with specific aspects of the disease. This research has the potential to improve early diagnosis of Alzheimer’s and help in the development of treatments to improve blood flow and reduce inflammation in the brain, which are likely to slow cognitive decline.

Thomas Montine, MD, PhD

Leland Stanford Junior University

Thomas Montine, MD, PhD

  • Blood

Dr. Montine and his team have identified novel biomarkers associated with neuroinflammation from a cohort of 122 participants. Now, they seek to validate these blood-based biomarkers in a larger cohort, and to test if they can be utilized as predictors of Alzheimer’s disease. The ability to measure biomarkers of neuroinflammation will enable better stratification of patients in clinical trials.

Foundation for the National Institutes of Health, Inc. (FNIH)

Wesley Horton

  • Blood

In a consortium of pharmaceutical companies and academic institutions, the team led by Mr. Horton at the FNIH aims to evaluate several methods to measure blood Neurofilament (Nf). Nf is a protein polymer that provides structural support for nerve fibers and becomes elevated with the onset of neurodegeneration. The goal is to determine whether the methods are sufficiently robust and reproducible to be utilized as a biomarker for increased risk of conversion to symptomatic disease in individuals with Familial Frontotemporal Degeneration (f-FTD) mutations.

Bruno Steinkraus, PhD

Hummingbird Diagnostics

Bruno Steinkraus, PhD

  • Blood

Hummingbird Diagnostics is developing an innovative blood test to detect circulating microRNAs, molecules that regulate many processes in the brain. Growing evidence shows that levels of microRNAs in the blood may be a reliable biomarker showing progression of Alzheimer’s and other diseases that involve neuron degeneration. The goal of this research is to optimize a test that can be used widely to detect Alzheimer’s before symptoms begin to allow for earlier diagnosis, and ultimately earlier treatment.

Gregory Penner, PhD

NeoNeuro S.A.S.

Gregory Penner, PhD

  • Blood

NeoNeuro has developed a potentially revolutionary approach to diagnostics using aptamers. Aptamers are small synthetic DNA sequences that bind to targets in blood which are diagnostic of various stages of Alzheimer’s disease. These aptamers can be rapidly and cost-effectively used on individual blood samples with the technological platforms (called polymerase chain reaction, PCR) already available in testing laboratories. The blood test could potentially identify individuals with high levels of amyloid (a key risk factor for the onset of Alzheimer’s disease) and aid in pre-screening of potential enrollees for clinical trials.

Henrik Zetterberg, MD, PhD

University of Gothenburg

Henrik Zetterberg, MD, PhD

  • Blood

Dr. Zetterberg and his lab are working in collaboration with Roche Diagnostics to develop a blood test to detect beta amyloid protein fragments Aβ40 and Aβ42. Detection of these proteins in the blood are highly correlated with the presence and progression of Alzheimer’s disease. This blood test is one of the most advanced in development for diagnosis of Alzheimer’s disease.

Kaj Blennow, MD, PhD

University of Gothenburg

Kaj Blennow, MD, PhD

  • Blood

Dr. Blennow's team is developing the first ultra-sensitive blood test to detect brain-specific tau. His team has identified brain-derived tau protein fragments in cerebral spinal fluid that correlate well with Alzheimer's disease pathology and will now extend this unique approach into blood tests, which are much easier and cheaper to perform than spinal taps.

Fujirebio

Manu Vandijck, MSc

  • Blood

Dr. Vandijck and his team are developing and validating a blood test to assess levels of brain pTau181 in a neurologically diverse population. Commercialization of an easy-to-run and fully automated blood test will help with simple and rapid identification of individuals with Alzheimer’s disease, facilitating more efficient drug trial enrollment. It may also assist in diagnosis of the millions of individuals suffering from dementia.

Marta Barrachina, PhD, MBA

ADmit Therapeutics S.L.

Marta Barrachina, PhD, MBA

  • Blood

ADmit Therapeutics has developed a way to measure the dysfunction inside cells by examining modifications to mitochondrial DNA, which are associated with a variety of pathologies including neurodegenerative diseases. The team has found that specific modifications of this DNA are predictive of progression to Alzheimer’s disease and may represent an early indicator of the disease. Development of a blood test to evaluate these DNA modifications could potentially enable better selection of patients for clinical trials and further understanding of the disease.

Nicklas Linz

ki elements

Nicklas Linz

  • Digital

The aim of this project is to replace in-person manual pre-screening procedures for clinical trials with remote automated methods using a telephone or smartphone with ki elements’ Δelta application, which utilizes cognitive testing and advanced speech-based analytics. The pre-screening process involves the conduct, evaluation, and reporting of neuropsychological testing. This approach will reduce cost and clinical trial screening time for trial participants at the pre-symptomatic stage of Alzheimer’s disease.

ETH Zurich

Rafael Polania, PhD

  • Digital

ETH Zurich has developed portable technology (EAR-DREAM) that provides long-term, non-obtrusive recordings of brain signals from the ear. In this study, EAR-DRUM will record these signals in the largest known population of patients who carry the autosomal dominant Alzheimer’s mutation (ADAD), which carries a 100% chance of developing Alzheimer’s, and compare them to recordings from a control group that does not carry the ADAD mutation. Investigators will develop, via state-of-the-art predictive models, a robust biomarker of Alzheimer’s risk from the data collected.

Saliha Moussaoui, PhD

Amoneta Diagnostics SAS

Saliha Moussaoui, PhD

  • Blood

Amoneta Diagnostics is developing a rapid non-invasive blood test to detect mild cognitive impairment (MCI) due to early Alzheimer's disease (in support of the MemoryLINC project) versus other types of dementia. The test panel measures two species of ribonucleic acids (RNA) that are stable in the blood and show promise as biomarkers for early detection of Alzheimer's disease.

Tom MacGillivray, PhD

University of Edinburgh

Tom MacGillivray, PhD

  • Eye

Dr. MacGillivray is developing a comprehensive eye scan designed to analyze a novel combination of retinal biomarkers that signal brain neurodegeneration associated with Alzheimer’s disease. The results of this project, if successful, may be offered for widespread use as a cloud-based system for analyzing retinal images or incorporated into existing eye scan device software.

Zoe Kourtzi

Alzheimer's Research UK

Zoe Kourtzi

  • Digital

The Early Detection of Neurodegenerative diseases (EDoN) initiative aims to develop an integrated digital device. As part of the device creation, EDoN intends to evaluate sleep patterns, physical activity levels, smartphone interactions, cognitive function and mood data using wearables and smartphone applications. The integrated device will enable the detection of specific dementia-causing diseases 10-15 years before symptoms become noticeable and can then be used to encourage risk-reducing lifestyle changes, to triage individuals into clinical diagnostic testing, to facilitate research into early stages of disease progression, and to aid the development and testing of therapeutic interventions.

Chris Edgar, PhD

Cogstate Ltd

Chris Edgar, PhD

  • Digital

Cogstate is developing and validating a mobile app for earlier identification of memory problems. The app uses an established test of memory, the International Shopping List test (ISLT), which presents a real-world scenario of remembering a shopping or grocery list. By adapting the test to be completed on either a smartphone or tablet at home, it will reach individuals who may be unable or unwilling to travel to see a doctor and will allow for regular testing to detect cognitive decline. The test will be validated for use among diverse populations. This will in turn support earlier diagnosis, better access to clinical trials, and it is hoped—eventual access to treatment for everyone.

The Chinese University of Hong Kong

Guoliang Xing, PhD

  • Digital

Using motion, acoustic, and visual sensors in smart devices like smart phones and wearables, Dr. Xing and his team at Chinese University are collecting data remotely on activities of daily living from 200 individuals. They will then use deep learning technologies—which mimic the work of the human brain—to recognize, classify and analyze the data, and turn it into interpretable algorithms that can help with both early detection and diagnosis of individuals at higher risk of developing dementia, as well as developing personalized intervention strategies.

Monash University

Matthew Pase, PhD

  • Blood

The team at Monash University will evaluate whether their blood test measuring neuroinflammation biomarkers can differentiate among the most common types of dementia (e.g., Alzheimer’s, frontotemporal dementia) in an ethnically diverse group of 600 patients with newly diagnosed dementia. This work will add to the growing knowledge about the biology of neuroinflammation in different dementias and pave the way for minimally invasive diagnostic tools that can aid with diagnosis.

Peter van Wijngaarden, PhD

Centre for Eye Research Australia

Peter van Wijngaarden, PhD

  • Eye

Dr. van Wijngaarden's study will test a simple, inexpensive eye scan, using a special camera designed to detect amyloid in the retina years before Alzheimer’s symptoms appear. The study is currently being conducted in healthy adults with a family history of Alzheimer's disease. The study will establish whether this novel eye imaging technique can replace expensive PET imaging.

Medical Research Development and Health Services Fund by the Sheba Medical Center

Ramit Ravona-Springer, MD

  • Digital

Dr. Ravona-Springer and her team are developing a novel virtual reality tool that will objectively measure apathy. Apathy impacts many patients with Alzheimer’s disease and is often misdiagnosed as depression, leading to unnecessary and incorrect therapeutic intervention as well as increased caregiver burden. This virtual reality tool has the potential to advance clinical trials focused on developing effective therapies for apathy caused by dementia by providing objective measures for patient selection.

Yuval Dor, PhD

Hebrew University

Yuval Dor, PhD

  • Blood

Dr. Dor and his colleagues have developed a way to detect the source of DNA in the blood and have identified brain specific DNA markers. This DNA is only released when brain cells die, which is a hallmark of Alzheimer’s disease. In preliminary studies, Dr. Dor’s team found much higher levels of this DNA in people who had Alzheimer’s but who did not yet have symptoms compared to people without Alzheimer’s. This means that the death of brain cells can be detected very early in the course of the disease. This project will work to refine the test and assess it in a larger pool of early Alzheimer’s patients to ensure it will be valuable for widespread use in early detection of the disease.