Pharma group seeks digital measure standards for Alzheimer's

Big greasy gears in the old machine.

A group of pharma companies and academic groups have joined forces with the Digital Medicine Society (DiMe) to develop standardised, digital clinical measures that can be used in the development of therapies for Alzheimer's disease and related dementias.

According to the consortium – which includes drugmakers Biogen, Eisai, Eli Lilly and Merck & Co – there is a lack of measures that can be used to determine whether new therapies for Alzheimer's are actually working.

At the same time, digital tools such as wearable sensors are increasingly being used to understand the impact of disease and therapies on peoples' lives. The challenge is how to reliably harness those "digital indicators" to inform the development of new dementia drugs.

The move comes as the first approved drug for Alzheimer's – Biogen and Eisai's amyloid-targeting antibody Aduhelm (aducanumab) – is barely being used amid debate about its efficacy and safety as well as the validity of amyloid plaque clearance as a surrogate endpoint for effectiveness in trials.

The aim of the DiMe project is to "develop a core digital measure set to bring consensus, consistency, and effectiveness to how we measure the symptoms of [dementias] to improve drug development and clinical care," it said in a statement.

One element will be to explore measures that extend beyond the cognitive features to other impacts of dementia on patients' daily lives, according to the group, which also includes the Alzheimer's Drug Discovery Foundation, Boston University, and Oregon Health & Science University.

The first question to answer will be what symptoms are most important to patients, carers and clinicians around the world, according to DiMe's chief executive Jennifer Goldsack.

It's the second consortium set up by the group in the last couple of weeks, coming after it launched a project to drive inclusivity in clinical trials backed by digital technologies.

It's DiMe's second project to focus on a specific disease area, coming after work to develop nocturnal scratch as a digital endpoint for atopic dermatitis studies last year.

"Digital measures offer enormous promise to bolster collective understanding of Alzheimer's disease and related dementias," commented Jian Yang, associate vice president of digital health at Lilly.

"These measures can deepen our knowledge of disease progression, define new disease phenotypes, and support earlier diagnosis," he said, adding that these are "all critically important insights for a condition where inaccurate and delayed diagnosis is common and current standard of care does not target the underlying plaque pathology."

Other potential collaborators in the dementia group are welcome to register their interest here, according to DiMe, which expects the project to get underway next month.

"Through this holistic lens, the collaboration will be able 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," said Goldsack.