Our industry knows better than most that failure is an intrinsic and important part of scientific research and development.

Even when the development of a potential new medicine isn’t successful, it can still play a crucial role in understanding a disease and provide important data for the next step of the journey. The journey toward new treatments for Alzheimer’s Disease is an example of how previous setbacks are now leading to new scientific breakthroughs.

The challenge of developing treatments for Alzheimer’s Disease

Alzheimer’s Disease, the most common form of dementia, is a relentless neurodegenerative condition that robs people of their memories, their independence and plans for the future, their relationships, and ultimately, their lives.

Nearly 10 million people are diagnosed with dementia every year, and more than 55 million people are living with the disease worldwide. It’s the seventh leading cause of death and one of the major causes of disability amongst older people globally. As the population ages, the number of people affected will continue to rise, reaching 78 million in 2030 and 139 million in 2050.

Alzheimer’s Disease is a progressive degenerative disease that develops over decades, often causing changes in people’s brains long before cognitive symptoms begin. Yet it’s very hard to diagnose it early enough, when there is a greater chance to benefit from treatments that could be more beneficial, or to participate in clinical trials. Challenges still exist in disease understanding (i.e. the correlation between neuropathological changes and cognitive symptoms) and in the way the disease is approached in clinical practice and perceived by society.

This makes it challenging to develop medicines that can slow the progression in this critical early stage. But intervening early, before disease severity impacts daily life, could have enormous benefits for patients, their families, and society more broadly.

New scientific breakthroughs leading to new treatments

In 2019, it was reported a 99% failure rate of clinical trials in Alzheimer’s disease. But after decades of persistence, new Alzheimer’s treatments are finally succeeding in clinical trials and undergoing regulatory review.

New Alzheimer’s treatments are finally succeeding in clinical trials and receiving regulatory approval.

These treatments have been shown to help slow the progress of Alzheimer’s Disease by removing amyloid, a sticky protein that builds up in the brains of people with the disease. It’s an exciting and hard-won breakthrough. While not a cure, this scientific breakthrough offers a solution for slowing disease progression for patients who, up until now, have only had access to treatments for managing symptoms.

Innovation takes decades of persistence

The long journey to new treatments for Alzheimer’s Disease reminds us of the risk behind innovation and, more than ever today, it’s important that innovation is encouraged by a strong and predictable regulatory framework. There is no guarantee for success, but pharmaceutical companies persist in investigating new ideas – often for decades – because breakthrough innovations can take time to discover. Eli Lilly have been working for over 30 years in Alzheimer’s research. It is this determination that ultimately delivers new treatments that will improve life for patients and their loved ones. As of January 2022, there were 143 candidate medicines in clinical trials for the treatment of Alzheimer’s Disease.

Even when innovation fails, valuable lessons are learned. Much of what we now know about promising new Alzheimer’s treatments has come from research that failed to reach its original goal. Data gathered by unsuccessful clinical trials has answered existing questions and posed new ones. Setbacks have provided crucial scientific learnings and shown us the way to the life-changing treatments that people with Alzheimer’s Disease are waiting for.

A collective effort from all stakeholders is needed

Research and development in such a high unmet medical need disease will continue. Alongside this, it is also important that we have discussions about how we can reorient healthcare systems toward different approaches to care.

Healthcare systems should enable clinicians to take swift action when they suspect a person has cognitive impairment arming them with the knowledge, tools, and resources needed to diagnose Alzheimer’s Disease earlier and more accurately, including access to the diagnostic biomarkers (PET scans or CSF) and, in the near future, enable the joint use of blood-based biomarkers.

Although there are challenges ahead, what’s clear is that we can make a huge difference if we work together. Through collective efforts from stakeholders, at all stages of the journey, we can ensure that new Alzheimer’s Disease treatments are successfully used to transform lives globally.

Author

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  Laura Campo Executive Director International Corporate Affairs, Alzheimer’s disease, Eli Lilly