Founded in 2005, the Accelerate Cure/Treatments for Alzheimer’s Disease (ACT-AD) Coalition is a group of more than 50 national nonprofit organizations urgently working to speed up the development of potential cures and more effective treatments for Alzheimer’s disease (AD).
ACT-AD supports accelerating research into transformational therapies to better treat and potentially slow, halt, or reverse the progression of Alzheimer’s disease.
Why ACT-AD Now
The number of Americans with Alzheimer’s disease and other dementias will grow each year as the proportion of the U.S. population over age 65 continues to increase.1 From 2010 to 2050, the total costs of care for Americans age 65 and older with Alzheimer’s disease will increase five-fold, from $172 billion to $1.08 trillion per year. These dollar amounts represent the direct costs of care to all payers, including Medicare, Medicaid, out-of-pocket costs to people with the conditions and their families, and costs to other payers (such as private insurance, HMOs and other managed care organizations, and uncompensated care).2
In the current regulatory environment, research being performed today cannot reach patients in time to avert this disaster. CNS drugs, a category that includes Alzheimer’s treatments, take on average 13 years from initial animal studies of a drug to approval for use in humans.3 A one-year delay in bringing a treatment to market represents one-third of a million patients and their families who will suffer.
ACT-AD is committed to bringing transformational therapies to patients, providers, and families in the next decade by making the acceleration of promising Alzheimer’s disease therapies a top national priority.
- Approved AD therapies only address some of the symptoms, not the underlying disease pathology of AD
- The lack of national priority placed on Alzheimer’s disease allows for delays in the drug development process
- The Alzheimer’s patient and caregiver communities have not been engaged or involved in defining acceptable risk for the potential benefit that may come from treatments that have the potential to modify the underlying AD pathology
Goals and Objectives
- Immediate public and government recognition of Alzheimer’s disease as a debilitating, dehumanizing, and life-threatening disease that requires urgent attention
- To bring transformational therapies to patients, providers, and families in the next decade by making the acceleration of promising Alzheimer’s disease therapies a top national priority
- To create a sense of urgency in support of bringing AD products to market
- To obtain public and government recognition of AD as a serious, life-threatening epidemic that will strain the federal budget
- To accelerate development of safe and efficacious symptomatic and disease-modifying therapies for AD
Until the formation of ACT-AD in 2005, there was no single point of advocacy around the need for better treatments to combat Alzheimer’s disease that combined the perspectives and commitment of respected, diverse advocates for women’s health, consumer interests, caregiver groups, and aging organizations.
Since a milestone meeting ACT- AD representatives conducted with the FDA Commissioner and other top FDA officials in 2006, the federal agency has taken a number of actions in response to ACT-AD’s advocacy. FDA agreed to work with the coalition on an annual workshop where representatives from the FDA, including the reviewers of neurologic products, can interact with leaders in the patient advocacy community, academe, and industry on issues that are either current or potential roadblocks to the successful review of new Alzheimer’s disease products.
In 2006 the agency established a “Neurology Across FDA” intra-agency working group that includes representatives from FDA’s Office of the Commissioner, the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiologic Health (CDRH), and the Office of Health and Constituent Affairs (OHCA). This working group regularly discusses how the different centers and offices that have a hand in the review of neurology products can pool expertise and collaborate more effectively on the evaluation of promising new treatments for Alzheimer’s.
FDA also extended its patient representative program to Alzheimer’s patients and caregivers. This was the first step in giving a face and a voice to those with the disease in the drug review process. Previously this patient representative program had only been utilized for HIV/AIDs and cancer.
At the fifth Clinical Trials in Alzheimer’s Disease Conference, ACT-AD organized a symposium that was comprised of presentations by regulators from the U.S. and Europe and representatives involved in efforts to standardize data, biochemical assays, and neuroimaging protocols for AD. The symposium shed light on similarities and differences between FDA and EMA requirements for achieving disease modification in pre-symptomatic AD—with a goal of highlighting how, in addition to guidance, new regulatory science initiatives could expedite drug development.
Leading up to this symposium, the Coalition convened a 12-member expert panel to summarize the latest research on currently available biofluid and imaging biomarkers for AD and provide an expert perspective on how to use these biomarkers most effectively for streamlining therapeutic discovery and development. The work of this panel resulted in the publication of a special supplement issue of Neurobiology of Aging highlighting areas of consensus.
- ACT-AD continues to work with FDA officials and other policymakers to increase the attention and resources they devote to the challenges posed by AD
- ACT-AD convenes an annual high-impact meeting and webinars with the FDA and members of industry on topics ranging from measuring clinical meaningfulness in AD to improving the efficiency of Phase II Alzheimer’s trials, pursuing combination therapy development for Alzheimer’s disease, and the scientific foundation for Alzheimer’s disease therapeutic development
- ACT-AD successfully called for the inclusion of patient representatives and patient advocates earlier in the drug review process as part of stakeholder meetings leading up to the reauthorization of the Prescription Drug User Fee Act
- To better serve people with neurodegenerative disease like Alzheimer’s disease, the coalition continues to advise FDA on the implementation and refinement of its Patient-Focused Drug Development Initiative
- To support ACT-AD’s direct engagement with FDA, the coalition continues to lead activities that advance consensus on needed research and tools to support regulatory efforts to prioritize drug review for Alzheimer’s disease
3. Center for the Study of Drug Development, Tufts University. 1995