A group of experts on Alzheimer’s Disease are contesting the U.S. Government’s pro-active plans to prevent and treat the disease until 2025, as they believe the milestones defined by the National Plan to Address Alzheimer’s Disease need to be broadened in scope, increased in scale, and adequately funded in order to be successful. Almost 40 researchers and scientists have proposed a series of measures to enlarge and strengthen the governmental plan in an article published in Alzheimer’s & Dementia: the Journal of the Alzheimer’s Association, entitled, “Perspective on the ‘2014 Report on the Milestones for the US National Plan to Address Alzheimer’s Disease.'”
“Many prominent investigators believe the prospect of delaying the onset of disabling symptoms within a decade is an attainable goal, provided we can surmount several scientific, administrative, and most importantly, financial impediments,” wrote the authors, which include both academic and industry experts from different areas of studies regarding Alzheimer’s. “Inadequate funding remains the single most important impediment to progress in achieving the research goal of the National Plan.”
The proposals take into account the fact that in the United States alone there are over five million people living with Alzheimer’s, costing the country about $214 billion annually, according to the numbers of the “Alzheimer’s Association 2014 Alzheimer’s Disease Facts and Figures” report. With the increase of the average life expectancy in the U.S., the numbers tend to rise even more, with estimates of the disease affecting 16 million patients, leading to $1.2 trillion in costs for the nation by 2050. The researchers believe that the governmental action needs to be faster and stronger to counteract this trend.
“We are a scant 11 years from the 2025 goal of the Plan, and we have no time to lose,” said the Alzheimer’s Association vice president of Medical and Scientific Relations and a co-author of the article, Maria Carrillo, Ph.D. “We commend the U.S. National Institute on Aging for creating the original milestones that have been incorporated into the Plan, and for committing to revising these milestones regularly.
“Further, the NIA has created an excellent opportunity to update these milestones in conjunction with its Alzheimer’s Disease Research Summit to be held in February 2015. While our workgroup does not believe the milestones, as they currently stand, are sufficient to reach the 2025 goal, if the suggested updates are swiftly implemented and funded we believe prospects for being able to prevent and effectively treat Alzheimer’s by 2025 will increase dramatically,” Carrillo added.
While the National Plan to Address Alzheimer’s Disease, which was released in 2012 after a year’s worth of work by the National Alzheimer’s Project Act (NAPA), is the first of its kind to outline both initiatives and tools for physicians, caregivers, and patients on dementia, as well as raise awareness and advance research, the workgroup is not confident about the success of the “Prevent and Effectively Treat Alzheimer’s Disease by 2025” program. As a result, they have established a series of strategies as a way of enlarging the scale of the plan, as well as expanding its scope and better coordinate it.
The authors have proposed a revision of the milestones of the plan, as well as 25 new milestones regarding drug development, risk reduction, and new conceptual models of Alzheimer’s. They believe that it is crucial to conduct more clinical trials in order to not only test further drug- and non-drug strategies, but also to include more patients. The experts also note the importance of performing more basic research as a way of finding and validating biomarkers and new therapeutic targets, as well as stronger research systems and infrastructures based on collaboration, interdisciplinary efforts, and data sharing.
Even though the authors support the goals of the current six milestones that focus on the development of novel targets into effective treatments, they also noted that only 13% of new medications pass through preclinical stages into phase III trials, which they believe reveals that six is too few. In order to be successful, at least 23 drugs would have to be validated, and yet the milestone only calls for six, they say. Therefore, the researchers suggest that the milestone should identify 60, given the mechanisms a drug needs to pass through. In addition, the group also recommends the adjustment of the costs as a reflection of the drug development reality.
The authors also emphasize the importance of epidemiological studies in providing data about the risks of developing dementia, including genetic, vascular, psychosocial, dietary, and other lifestyle factors, and recommend that more resources are invested in epidemiological infrastructure and studies to improve the outcomes of the method. First, they believe that a reframing of the plan is needed in order to focus on both prevention and risk factors.
In addition, they also recommend a large, multi-domain prevention trial focused on modifiable risk factors in the United States to replicate the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) multi domain prevention trial, in a larger, more diverse population. The FINGER study, which was presented at the 2014 Alzheimer’s Association International Conference, analyzed diet, physical exercise, cognitive training, social activities, and control of vascular risk factors, and has enhanced the advantages of epidemiological studies.
Regarding new models of Alzheimer’s, the authors believe that creating mechanisms of funding training and research programs on the basics of the biology of aging, vulnerabilities, and disorders of the brain and nervous system, as well as reexamining the current models, might help overcome barriers to new and alternative methods. These barriers may include a lack of tools, infrastructure, and resources, especially concerning basic science and pre-clinical research.
The authors believe that the existing treatment approaches should be rethought, since it hasn’t yet been possible to develop an effective cure. The group aims to re-examine existing paradigms and consider new conceptual models of Alzheimer’s, in line with the Alzheimer’s Association’s Research Roundtables, which have been considering new mechanisms, rather than the established idea of amyloid as a cause for the neurodegeneration and consequently Alzheimer’s.
“This article is the voice of leading scientists recommending what needs to be incorporated into the Plan’s milestones now to prevent and effectively treat Alzheimer’s and other dementias,” stated the chair of the Alzheimer’s Association Medical and Scientific Advisory Council, William Klunk, M.D., Ph.D., who is co-author of the article, Distinguished Professor of Psychiatry and Neurology at the University of Pittsburgh School of Medicine in Pittsburgh, and Co-Director of the Alzheimer’s Disease Research Center at the University of Pittsburgh.
“The suggested milestones outlined in the article identify significant increases in the scope and scale of Alzheimer’s research, which would bring Alzheimer’s research efforts more closely into line with the scale of activity needed to make substantial progress against other major diseases like Cancer and HIV/AIDS. The proposed revisions are meant to ensure that the National Alzheimer’s Plan’s milestones outline an adequate level of both the types and amount of research that are needed to achieve the 2025 goal,” added Klunk.