Standardized digital test will expand early diagnosis capabilities to more primary care physicians
NEW YORK, April 29, 2025 -- The Alzheimer's Drug Discovery Foundation (ADDF)'s Diagnostics Accelerator (DxA) today announced a significant investment that will support clinical validation for the digital version of the Montreal Cognitive Assessment (MoCA), MoCA Solo, an automatically scored test for tablet devices utilizing AI-enabled avatars, requiring only minimal supervision. The original MoCA is a one-page 30-point pen-and-paper cognitive test that is administered in ten minutes and used worldwide by trained professionals. MoCA Solo does not require trained administration, and if successful, MoCA Solo could be more widely used as a scalable tool for assessing mild cognitive impairment (MCI), especially in primary care clinical settings.
"Combining the MoCA Solo assessment with blood biomarkers has the potential to enable earlier detection of Alzheimer's disease by identifying individuals with MCI who are most likely to benefit from specialist care," said Howard Fillit, MD, Co-Founder and Chief Science Officer of the ADDF. "A scalable, accessible, and standardized assessment that can be easily administered across a variety of clinical settings empowers primary care physicians to play a more prominent role in the front lines of diagnosing and treating Alzheimer's. As the Alzheimer's population continues to grow, exceeding the capacity of specialists, conducting assessments at the primary care level is a critical step towards getting patients and their families the support they need sooner."
Given the success of recently approved Alzheimer's drugs, Leqembi and Kisunla, comprehensive diagnosis and evaluation require both biomarker testing and cognitive testing to provide a holistic assessment of a patient's Alzheimer's and disease progression. While blood-based biomarkers are most likely to become the gold standard for the early diagnosis and detection of Alzheimer's-related biology, the addition of digital standardized cognitive assessment will provide complementary information on a patient's cognitive state, helping to determine which individuals are in the earliest stages of the disease and would benefit from referral to specialist care.
Development of and access to standardized assessment and diagnostic tools is a foundational goal of the ADDF's Diagnostics Accelerator. Pairing cognitive assessment with individual biomarkers paves the way for early diagnosis and helps inform combination therapies that will allow us to treat Alzheimer's via precision medicine.
"As new Alzheimer's therapies come to market, it's more important than ever to have reliable, standardized, easy-to-deploy tools for early detection," said Niranjan Bose, Managing Director of Health and Life Sciences at Gates Ventures. "Digitizing the widely used MoCA test empowers primary care physicians to detect cognitive decline earlier and reduce bottlenecks with specialist referrals. When paired with blood biomarker testing, the information gives doctors a more complete picture of an individual's condition, enabling timely and targeted intervention."
"This investment by the ADDF underscores their commitment to innovation in digital diagnostics and expanding access to accurate, efficient cognitive testing at a national scale," said Dr. Ziad Nasreddine, creator of the MoCA, and CEO of MoCA Cognition. "We are proud to partner with the ADDF to help address the growing challenge of Alzheimer's disease."
The gold standard pen-and-paper MoCA, developed in 1996 and clinically validated in 2005, demonstrated 90% sensitivity and 87% specificity for detecting MCI. The assessment includes questions designed to assess short-term memory, visuospatial skills, executive function, language, attention, concentration, working memory, and orientation. Today, the MoCA is the most widely used cognitive assessment for early detection and has been translated into 200+ languages and dialects. It is regularly cited in scientific articles and is used by both specialists and primary care physicians. A 2023 global Delphi consensus of experts published in Alzheimer's & Dementia ranked the MoCA as the preferred tool for detecting MCI and early AD among 53 cognition scales considered (Ellison et al., 2023). A validated and automated digital version will reduce the need for human administrators and enable further adoption, especially within primary care.
About The Alzheimer's Drug Discovery Foundation (ADDF)
Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $370 million to fund 765 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 21 countries. To learn more, please visit: http://www.alzdiscovery.org/.
About the Diagnostics Accelerator (DxA)
The Diagnostics Accelerator, created in July 2018, is a $100 million global research initiative from partners including ADDF Co-Founder Leonard A. Lauder, Bill Gates, Jeff Bezos, MacKenzie Scott, 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.
This research initiative is dedicated to accelerating the development of affordable and accessible biomarkers to diagnose Alzheimer's disease and related dementias and advance the clinical development of more targeted treatments. Through translational research awards and access to consulting support from industry experts, this program will challenge, assist and fund the research community in both academia and industry to develop novel peripheral and digital biomarkers.
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