Pharma giants come together to draw up digital clinical measures for Alzheimer’s

USA –The Digital Medicine Society (DiMe) has announced a new collaboration involving Biogen, Eisai, Eli Lilly, and Merck & Co. to address a major barrier in determining whether potential treatments for Alzheimer’s disease and related dementias (ADRD) are actually working.

The parties hope to address the issue by developing a core set of digital clinical measures for ADRD.

The field has been plagued by a number of clinical failures, with each drugmaker involved in the new effort having been forced to abandon Alzheimer’s programs at some point in the past.

Meanwhile, one treatment that did receive regulatory approval – Biogen and Eisai’s Adulehm – is struggling to gain traction due to lingering concerns about its efficacy and safety.

Alzheimer’s disease is the most common form of dementia. It is a progressive brain disorder that destroys memory and thinking skills over time and impairs the ability to carry out daily tasks.

Alzheimer’s disease affects approximately 6 million Americans aged 65 and up. There are no proven treatments for the disease.

DiMe CEO Jennifer Goldsack indicated that the collaboration will use a “holistic lens…to identify where digital solutions can best help in developing new treatments, define meaningful clinical concepts to measure, and focus innovation and investment on advances that can best help combat this devastating disease.

According to DiMe, progress in advancing digital measures in ADRD has been slow for a variety of reasons, and little work has been done to understand “meaningful aspects of health” for these patients beyond cognitive features.

Consensus, consistency, and effectiveness

The group, on the other hand, claims that developing a core set of digital measures will bring “consensus, consistency, and effectiveness” to how the symptoms of ADRD are measured in order to improve drug development and clinical care.

“These measures can deepen our knowledge of disease progression, define new disease phenotypes and support earlier diagnosis,” said Jian Yang, associate vice president of digital health at Eli Lilly.

Martin Dubuc, who leads digital health at Biogen, also touted the promise of “objective, sensitive and validated digital biomarkers of neurodegenerative diseases such as Alzheimer’s,” while highlighting the “essential” nature of pre-competitive collaboration.

Meanwhile, DiMe stated that the initiative’s core digital measure set will become the focus of digital measure development work in ADRD, “preventing disparate and siloed efforts that limit progress.”

Prior to the project’s official launch in early April, the group stated that partners are still being considered.

Further to that, the more fit you are, the less likely you are to develop Alzheimer’s disease, with those who are the most fit having a 33% lower risk for this dementia than those who are the least fit, Washington post reports, citing a study to be presented to the American Academy of Neurology at its annual meeting next month.

For nearly a decade, researchers from the Washington VA Medical Center and George Washington University in Washington, D.C. tested and tracked 649,605 veterans (average age 61).

Participants were divided into five categories based on their cardiorespiratory fitness, from least to most fit.

The researchers discovered that as people’s fitness improved, their chances of developing the disease decreased.

When compared to the least-fit group, those who were slightly more fit had a 13% lower risk of Alzheimer’s; the middle group was 20% less likely to develop the disease; the next higher group was 26% less likely; and those in the most-fit group had a 33% lower risk.

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