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Led by Dr. Jeffrey Cummings, the Observatory will enable broader access to the biomarker pipeline, accelerating the development of novel drugs that will be used in combination with available drugs on the market. NEW YORK, Sept. 18, 2024 /PRNewswire/ -- The Alzheimer's Drug Discovery Foundation (ADDF) today announced a new investment to develop a first-of-its-kind Biomarker Observatory that will provide a comprehensive overview of the Alzheimer's biomarkers pipeline, including blood tests, brain scans, digital devices, and other tools that can help diagnose and monitor the disease. These efforts will be led by renowned clinical trialist Jeffrey Cummings, MD, ScD, Joy Chambers-Grundy Professor of Brain Science at the School of Integrated Health Sciences at University of Nevada, Las Vegas with Co-Principal Investigator Feixiong Cheng, PhD, from the Laboratory of Network Medicine at Cleveland Clinic. This Observatory will fill a critical gap by creating the first thorough overview of the biomarker pipeline, serving as a key resource to catalyze progress in drug development. "Biomarkers are integral for accelerating drug development and enabling an early and accurate diagnosis," says Howard Fillit, MD, Co-Founder and Chief Science Officer of the ADDF. "Innovative initiatives like the Biomarker Observatory will expedite the development of new biomarkers, which are needed to support the incredibly robust and diverse drug pipeline where nearly 75% of drugs in development are exploring novel pathways. Building upon our longtime partnership with Dr. Cummings and his colleagues, this investment exemplifies the critical role philanthropy plays in bridging research gaps and accelerating efforts that usher new and effective drugs through regulatory approval." The Observatory, which will be published regularly, will complement Dr. Cummings' annual clinical trial report—regarded as a gold standard resource on the Alzheimer's drug pipeline. A portal will provide investigators access to the evolving knowledge base. "The Biomarker Observatory is the natural counterpart to the clinical trial report, and the ADDF's support will help make it possible for researchers to access a comprehensive repository of the advancements in Alzheimer's research," notes Dr. Cummings. "With the drug pipeline now predominantly exploring novel aging pathways, the need for complementary biomarkers has never been more critical, especially as we look to develop the next phase of treatments." Biomarkers led to the approval of anti-amyloid drugs like Leqembi and Kisunla by helping to identify clinical trial participants and measure the drugs' target engagement. This class of drugs is shown to slow cognitive decline by approximately 30%, providing modest clinical benefit to patients. To provide additional clinical benefit, these anti-amyloid therapies will need to be combined with novel drugs targeting the other aging pathways. Similar to cancer and other diseases of aging, the accelerated development of combination regimens for Alzheimer's will only be possible with the necessary corresponding biomarkers. This timely collaboration will expand on the ADDF's longstanding efforts to seed the biomarker and diagnostics landscape for Alzheimer's, and it comes on the heels of recent progress in blood-based biomarkers, which are on track to the replace more invasive PET scans and spinal taps as the gold standard for diagnosing patients. In 2018, the ADDF launched the Diagnostics Accelerator (DxA) with leading philanthropists Leonard A. Lauder, Bill Gates, Jeff Bezos, MacKenzie Scott, and others, to fast-track the development of accessible and scalable biomarkers, and to advance the development of novel biomarkers. To date, the DxA has invested more than $60 million into 70 projects that range from blood tests and retinal scans to digital tools. As one of the preeminent leaders in Alzheimer's diagnostics, the Observatory will help the ADDF further its mission to conquer Alzheimer's through combination therapy and precision medicine, similar to cancer care. "Alzheimer's is a complex disease that will require a multifaceted solution. Now, with the Observatory and DxA, we are moving closer to the day where physicians can treat the right patients with the right drugs at the right time by leveraging a precision medicine approach." 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 $290 million to fund over 750 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 20 countries. To learn more, please visit: . 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The automated MIMneuro program utilizes the Centiloid scale, which aims to offer consistent measurements of amyloid buildup in brain tissue across various scanners and imaging tracers. GE HealthCare’s recently acquired MIM Software division has secured an FDA clearance for a tool to help quantify the density of amyloid plaque in the brains of people with Alzheimer’s disease.The automated MIMneuro program analyzes PET images from any scanner boosted by injectable radioactive tracer agents with the goal of providing a standardized metric for one of the main facets of the condition’s pathology.It utilizes the Centiloid scale, which aims to offer consistent measurements of brain tissue across various scanners and tracers; it ranges from a score of 0 among people highly likely to have no amyloid buildups, to a high of 100 that represents the typical patient with Alzheimer’s.With advances in pharmaceutical therapies over the past 18 months—including the FDA’s approvals of Eisai and Biogen’s Leqembi and Eli Lilly’s Kisunla—GE HealthCare has been positioning itself to provide the diagnostic support required before treatment. “As amyloid-targeting therapies continue to show meaningful results against Alzheimer's disease, PET imaging can help clinicians more confidently determine a patient's amyloid status,” Anja Mett, GE HealthCare’s global product leader for MI neurology, said in a statement. The company estimates that, by 2050, nearly 13 million people in the U.S. will be diagnosed with Alzheimer’s.“MIM Software’s new Centiloid scaling solution in MIMneuro is the latest addition to our growing portfolio of GE HealthCare Alzheimer’s disease care pathway solutions: including MR and PET scanners, and our amyloid PET tracer—combined with our digital solutions,” Mett added. GE HealthCare bought the Ohio-based MIM Software through a $295 million cash deal that closed this past April. The company had previously developed medical imaging and artificial intelligence programs for radiation oncology, theranostics, molecular radiotherapy and urology, including in nuclear medicine contouring and dosimetry.