Making 2025 Treatment Goal a Reality
By: Amy O'Connor
Somebody develops Alzheimer's disease every 66 seconds in the U.S. – and if we do not change the way we approach it, the disease will continue to rob the memories of loved ones and eventually cripple health care systems around the world.
In 2013, leaders from around the world made a commitment to identify a disease-modifying therapy for dementia. This would set the stage for a global initiative to reach this goal by 2025, spurring awareness campaigns, legislative action and solutions, additional funding to research, and much more. If we do not reach this goal or act swiftly to address this public health crisis, experts and leaders in the field estimate that, by 2030, there will be 74.7 million people with dementia. Additionally, the consequences due to inaction would drive the cost of caring for those with dementia to $2 trillion.
Recently, a working group of leading Alzheimer’s experts published an academic paper titled “Alzheimer’s Research & Therapy”. Through their analysis, they concluded that only a limited number of disease-modifying therapies have a chance to be approved and available to patients by 2025. The research continued by identifying the realities and challenges of achieving this 2025 treatment goal offered solutions to stimulate progress.
Today, more than 5 million people in the U.S. are living with Alzheimer’s, the most common form of dementia in late life, though many of them remain undiagnosed. Alzheimer’s is currently the sixth leading cause of death in the United States and if we don’t change course to reduce barriers to earlier intervention, such as stigma and complicated clinical trial recruitment, the number of Americans with the disease is estimated to triple by 2050.
In their paper the researchers named a number of these barriers that need to be addressed in order to keep the worldwide community on track to reach our 2025 goal:
- Improvement of clinical trial design: combining research phases and choosing appropriate primary endpoints may lead to more efficient clinical trials
- Updating patient registries: more advanced databases of healthy aged and symptomatic individuals could streamline clinical trial enrollment
- Encouraging earlier diagnosis: current clinical assessment tools are neither sensitive nor specific enough to detect early signs of the disease; more sensitive cognitive-assessment tools may capture subtle clinical decline among individuals with minimal symptoms
- Shift in regulatory environment: accelerated regulatory review processes, alignment of clinical trial endpoints with disease stage, and pivotal studies that test multiple patient populations could expedite drug approval
By acting on these solutions outlined by the working group, together, we can set the stage for continuing progress in the Alzheimer’s drug development field and advance further discussion and global action among industry, academia, and in the regulatory bodies. If we start today, with the proper adjustments and a collaborative approach to the solutions we have noted, we can make the goal of treating and preventing Alzheimer’s by 2025 a reality.