Muses Labs Brings Software Expertise to Alzheimer’s Disease Therapeutics

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by Charles Moore |

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alzheimer's softwareMuses Labs, based at Research Triangle Park in Raleigh, North Carolina, creates software-based systems to enable personalized therapy for the treatment of complex diseases. The company recently announced the development of its first offering for addressing Alzheimer’s disease. The combination therapy it implements is based on a broad understanding of the pathogenesis of Alzheimer’s disease, and aims to achieve Metabolic Enhancement for NeuroDegeneration (MEND) by targeting multiple interrelated biological mechanisms simultaneously. Muses Labs will soon launch a two-year observational study to test its methodology, targeting 200+ participants with Alzheimer’s disease.

The company says this approach to Alzheimer’s disease (AD) is based on the molecular biology of the brain and the bodily systems that support it. Decades of scientific research from around the globe are brought together and incorporated into MEND. Muses Labs combines medical expertise with software algorithms. Its algorithms figure out the optimal personalized therapy for an individual, and enables their physician to prescribe the therapy. Muses Labs software then motivates an individual’s adherence to the therapy it recommends.

The financial cost of dealing with Alzheimer’s disease annually in the USA is now estimated to exceed $200 billion, and doesn’t include the emotional expense borne by family members and caregivers of persons with Alzheimer’s disease, whose lives it irreparably compromises and 30 million affected globally.

An estimated 5.2 million individuals in the U.S.A. have Alzheimer’s disease, and every 67 seconds someone develops the disease. Women are at the epicenter of the Alzheimer’s epidemic, with almost 66 percent of individuals with Alzheimer’s disease and 60 percent of caregivers being women. Some 44 million individuals worldwide have some form of dementia — some 30 million with Alzheimer’s according to metrics cited by Muses Labs. In the absence of effective prevention and treatment, prospects for the future are of great concern, with 13 million Americans and 160 million globally projected to be afflicted with Alzheimer’s by 2050. The financial burden of treating the chronic diseases of aging is expected to rise steadily as Baby Boomers get older, leading to potential bankruptcy of the Medicare system.

Alzheimer’s disease involves a progressive loss of cognitive function, The underlying pathogenesis being loss of neurons in the hippocampus, cortex, and subcortical structures of the brain. The disease is the most common form of dementing illness among middle-aged and older adults. Symptoms typically appear after age 60, although some early-onset forms of the disease are linked to specific genetic defects. Although the etiology is unknown, genetic factors are thought play a role in 10 percent to 15 percent of cases.

Early disease stages show a loss of short-term memory, inability to learn new information, mood swings, difficulty in finding words, forgetting names, and losing items. Frustration, hostility, and irritability are common emotional features exhibited by patients with Alzheimer’s disease.

As Alzheimer’s progresses, patients become incontinent, memory is lost, and sense of time and place disappears. Patients become dependent upon others and eventually require comprehensive care. Because of a patient’s total dependency upon others, placement in a nursing home with full-time nursing care often becomes necessary. Thus, Alzheimer’s disease presents a considerable problem in patient management as well.

Ultimately, Alzheimer’s disease is fatal. Currently there is no cure or even a treatment that significantly slows progression of the disease, and every patient with Alzheimer’s dies with and because of the disease. A 2014 study in Neurology described how under-reported the Alzheimer’s death rate has been, and it is now recognized as a primary cause of death in the USA, on par with cancer and heart disease, and indeed, a woman’s chance of developing AD is now greater than her chance of developing breast cancer.

Unlike several other chronic illnesses, Alzheimer’s disease prevalence is on the rise, which makes the need to develop effective prevention and treatment increasingly pressing. Recent estimates suggest that AD has become the third leading cause of death in the United States, behind cardiovascular disease and cancer.

DaleBredesenIn a paper recently published September 27 in the journal Aging entitled Reversal of Cognitive Decline A Novel Therapeutic Program, lead author Dr. Dale E. Bredesen introduces a methodology for a combination therapy for Alzheimer’s disease. Dr. Bredesen directs the Mary S. Easton Center for Alzheimer’s Disease Research in the Department of Neurology at UCLA, is associated with the Buck Institute for Research on Aging in Novato, California, and is Chief Medical Officer of Muses Labs.

Dr. Bredesen’s report describes a novel, comprehensive, and personalized therapeutic program that is based on the underlying pathogenesis of Alzheimer’s disease, and which involves multiple modalities designed to achieve metabolic enhancement for neurodegeneration (MEND). The first 10 patients who have utilized this program include patients with memory loss associated with Alzheimer’s disease (AD), amnestic mild cognitive impairment (aMCI), or subjective cognitive impairment (SCI). Nine of the 10 displayed subjective or objective improvement in cognition beginning within 3-6 months, with the one failure being a patient with very late stage AD.

Six of the patients had been obliged to discontinue working or were struggling with their jobs at the time of presentation, and all were able to return to work or continue working with improved performance. Improvements have been sustained, and at this time the longest patient follow-up is two and one-half years from initial treatment, with sustained and marked improvement.

Dr. Bredeson suggests these results indicate that a larger, more extensive trial of this therapeutic program is warranted, and also that, at least early in the course, cognitive decline may be driven in large part by metabolic processes. Given the failure of monotherapeutics in AD to date, the results raise the possibility that such a therapeutic system may be useful as a platform on which drugs that would fail as monotherapeutics may succeed as key components of a therapeutic system.

He observes that neurodegenerative disease therapeutics has been, arguably, the field of greatest failure of biomedical therapeutics development. While patients with acute illnesses such as infectious diseases, or with other chronic illnesses, such as cardiovascular disease, osteoporosis, human immunodeficiency virus infection, and even cancer, have access to more effective therapeutic options, patients with AD or other neurodegenerative diseases such as Lewy body dementia, frontotemporal lobar degeneration, and amyotrophic lateral sclerosis.

In the case of Alzheimer’s disease, Dr. Bredeson notes that there is not a single therapeutic that exerts anything beyond a marginal, unsustained symptomatic effect, with little or no effect on disease progression. Furthermore, in the past decade alone, hundreds of clinical trials have been conducted for AD, at an aggregate cost of billions of dollars, without success. This has led some to question whether the approach taken to drug development for AD is an optimal one. However, the past few decades of genetic and biochemical research have revealed an extensive network of molecular interactions involved in AD pathogenesis, suggesting that a network-based therapeutics approach, rather than a single target-based approach, may be feasible and potentially more effective for treatment of cognitive decline due to Alzheimer’s disease.

The potential of the MEND approach was demonstrated, with sustained reversal of memory loss and improved cognitive function. Therapies recommended by Muses Labs algorithms go significantly beyond what is described in the paper. Muses Labs software analysis targets additional key biological mechanisms and recommends precise corresponding interventions.

Since first being described over 100 years ago, Alzheimer’s disease has been without an effective treatment. Repeated failure of monotherapies for Alzheimer’s disease has led researchers to pursue combination therapies. But, many interrelated biological mechanisms play into Alzheimer’s disease, and a corresponding combination therapy is at least an order of magnitude more complex than combination therapies currently applied to other disorders.

“Outcomes of other illnesses, such as cardiovascular disease, cancer, and HIV, have been improved through the use of combination therapies,” says Dr. Bredesen in a Muses Labs release. “Yet in the case of Alzheimer’s disease and other memory disorders, comprehensive combination therapies have not been explored. Over the past few decades, genetic and biochemical research has revealed an extensive network of molecular interactions involved in Alzheimer’s disease pathogenesis. That suggested that a broader-based therapeutics approach, rather than a single drug that aims at a single target, is feasible and potentially more effective for the treatment of cognitive decline due to Alzheimer’s disease”.

“The shift to applying a broad combination therapy to Alzheimer’s is a crucial turning point towards effectively treating Alzheimer’s disease, says Marwan N. Sabbagh, Research Professor of Neurology at the University of Arizona College of Medicine in Phoenix, and a key member of Muses Labs scientific team.

VikChandraThe complexities of Alzheimer’s disease necessitate an approach that relies heavily on advanced software, big-data analytics, and scientific research, says “Muses Labs CEO Vik Chandra. Muses Labs intends to utilize the Internet and recent technology innovations to make personalized combination therapy practical and accessible to every individual with Alzheimer’s disease around the world,” he concludes.

JohnQWalker“Because of the explosive combinatorics, the solution to Alzheimer’s disease is a systems-optimization problem,” says Chief Technology Officer of Muses Labs, Dr. John Q. Walker. “A new set of algorithms has been invented here to create personalized therapeutic recommendations. Muses Labs software infrastructure can receive individuals clinical data from a range of sources their medical team, caregivers, and Internet-connected devices to assess the state of the disease, track progress, and evolve an ongoing set of therapeutic recommendations.”

Muses Labs will soon launch a two-year observational study of 200+ participants with Alzheimer’s disease, at selected medical facilities across the country. As the therapy does not rely upon new drugs, but rather an innovative combination of existing pharma and broader-based therapeutics, wider availability is only a couple of years away.

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