My grandfather was a World War II veteran and a Pearl Harbor survivor. While I was fortunate to hear some of his stories, Alzheimer’s robbed me of the chance to learn more about his remarkable experiences. One day, he left the house to go to the post office but was found over two days later, in a different state, trying to get home after drinking only a milkshake for several days. Everything changed after that day.
Alzheimer’s disease affects roughly six million Americans, a number projected to double by 2050. The impact of this devastating disease extends far beyond the patient, taking its toll on their loved ones and caregivers.
Despite the rising prevalence of Alzheimer’s, studies suggest that an additional 33-44 million people who have some form of dementia remain undiagnosed, suggesting a much larger untreated population. As with many medical conditions, early detection of dementia is key, but not for the typical reason of increasing likelihood of a cure. After all, there is no known cure for Alzheimer’s and other dementias. But there is the unmeasurable benefit of giving those suffering more quality time with their loved ones while offering significantly improved quality of life.
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Historically, patients were diagnosed with Alzheimer’s disease when (and often because) they show signs of dementia or other associated symptoms. At that point, there is already a significant build-up of amyloid plaques and Tau protein tangles in the brain — which fuel the associated cognitive decline in Alzheimer’s patients, significantly impacting treatment success.
With the latest innovations and technological developments, we are in the midst of an unprecedented period of innovation and progress in the understanding, diagnosis and treatment of Alzheimer’s disease. Advancements in science have informed the development of a new generation of treatments that can address the underlying causes of the disease and grant those suffering more quality time with their loved ones while offering significantly improved quality of life, by slowing, stopping and even reversing the accumulation of plaques and proteins in the brain.
A few of these advanced disease-modifying therapies (DMT), including Leqembi® (lecanemab) and Kisunla™ (donanemab), have been approved by the U.S. FDA and are available to treat select patients by addressing the accumulation of the associated plaques and proteins in the brain. Other potentially promising DMTs are being evaluated in clinical trials and could become available to patients within the next couple of years.
While these emerging therapies signal new hope for beating Alzheimer’s disease, without diagnosis, patients cannot access such clinical trials or specialized care. To qualify for these DMTs or for clinical trials and other novel interventions, patients must first receive an early-stage Alzheimer’s diagnosis, and be at the initial stages of the disease, as these treatments work best for people with early or middle-stage dementia, suffering from mild to moderate symptoms and mild cognitive impairment. Fortunately, along with recent advancements in treatment, there have also been some significant steps forward in the development of highly sensitive diagnostic tests to detect the presence and progression of Alzheimer’s disease.
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Blood tests – a potential solution for scalable, accessible early diagnosis
Alzheimer’s disease and dementias are difficult to diagnose. The accumulation of Tau proteins in the brain is one of the hallmarks of Alzheimer’s disease, related dementias, and other neurological conditions and brain injuries. Detecting these proteins using blood-based tests can be challenging because only very small amounts are able to pass through the blood-brain barrier. This semi-permeable layer of cells surrounds the brain, protecting it from potentially harmful elements circulating in the blood. The blood-brain barrier acts like a fine filter, preventing larger molecules from penetrating or leaving the brain and entering the bloodstream.
Lacking highly sensitive blood tests, researchers and clinicians have relied on the current standard— positron emission tomography (PET) imaging and analysis of cerebrospinal fluid (CSF) obtained via lumbar puncture — which are expensive, invasive, limited in availability and difficult to provide at the scale required. Even patients with access to these tests will often wait months for an appointment and even longer for a definitive diagnosis, while their condition deteriorates.
Within the past few years, however, breakthroughs in science and technology have led to the development of highly sensitive blood tests that can detect even very minute levels of phosphorylated tau 217 (pTau217)—a critical biomarker for Alzheimer’s diagnosis and progression tracking. These tests have been proven to be as accurate and sensitive as PET and CSF testing, but are much less invasive, more affordable, scalable and accessible.
Moreover, these newer tests can detect the presence of Alzheimer’s disease in the very early stages — sometimes years before symptoms appear. Several pTau217-based tests are already being used for research and in clinical trials, helping to support the advancement of promising new treatments. Other in vitro diagnostic (IVD) pTau217 tests are being developed by leading diagnostic companies that, when approved by regulators, could be utilized in a variety of clinical settings, bringing convenient, accurate testing and the possibility of early detection and treatment closer to millions of patients around the world.
A new future of Alzheimer’s diagnosis
This breakthrough democratizes access to diagnosis and supports the scalability needed to test the millions of patients suffering globally, offering precise results on advanced and widely available platforms. The pTau217 antibody can be incorporated into advanced assays and analytical platforms, providing rapid, convenient, and affordable blood testing for Alzheimer’s, and will soon be available at the scale required to meet growing demand.
Beyond facilitating early intervention, blood-based tests pave the way for personalized medicine and continuous patient monitoring. By matching drugs to specific disease profiles and monitoring treatment responses, these tests promise to reduce treatment inefficiencies and improve overall care outcomes.
Upon treatment initiation, clinicians can utilize these convenient blood tests to monitor their patients’ responses, allowing appropriate adjustments to therapy regimens and minimizing time and money spent on ineffective therapies. It can also be a critical tool in monitoring post-treatment changes in patient status. Moreover, early diagnosis through blood tests buys invaluable time – for patients and their families to plan, seek support, make informed decisions about their difficult care journey and, perhaps most importantly, be together.
In the U.S. alone, about one in nine people over the age of 65 (or seven million people) are in a race against time. The development and widespread availability of blood-based testing in the near future will help slow down the clock and provide invaluable opportunities for patients and their families to plan, seek specialized care or access to clinical trials and new DMTs, make informed decisions about their treatment journey and, perhaps most importantly, enjoy life together.
Photo: wildpixel, Getty Images
With over 20 years of experience as a life sciences company builder and operator, Chad Holland, CEO and president of ALZpath, is a seasoned executive known for his proficiency in managing various product and company stages. He has a proven track record in entrepreneurial leadership, product launches, alliance management, business development, and sales & marketing. Prior to his current role, Chad was the Chief Commercial Officer at Valo Health.
Throughout his career, Chad has contributed to the success of diverse companies, including Danaher Corporation, Voyager Therapeutics, Enobia Pharma (acquired by Alexion), Synhale Therapeutics, and Mylan, as well as Stryker, Medtronic, and SC Johnson. His educational background includes an undergraduate degree in Chemical Engineering from the University of Wisconsin, an MBA from the Kellogg School of Management at Northwestern University, and dual Master’s degrees from the Harvard-MIT Biomedical Enterprise Program.
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