“…The [US Senate] measure would hike spending for Alzheimer’s research to more than $2.3 billion, essentially quadrupling spending levels from four years ago on a disease that requires hundreds of billions of dollars for dementia-related care….” Matthew Daly, AP News 8.23.18
Press Release: The Fantasy National Institute of Getting Things Done (formerly called Rational Good Intentions) announced a Czarina for Alzheimer’s Dementia, giving her the ambitious mandate to make a positive impact for present day patients, within the next two to five years.
Dr. Alzheimia Aloysious was named, and given a budget of $191M (part of the $597M incremental request that this year may put the budget over $2B, see graphics above and below). She has a unique background, working successfully in brain cancer clinical trials. She’s board certified in both Oncology and Neurology with an MPH in Biostatistics. She created and coordinated innovative aggressive cross-over multi-agent trial designs, and was able to establish a multi-institutional and multi-national collaboration to ethically recruit investigators and patients, collect imaging and lab data, and produce results.
“Yes, clinical cancer is better funded, and clinical work here is less than a third of the Alzheimer budget, but that’s no excuse. We need better clinical trials right now in Alzheimer’s disease and other dementias,” stated Dr. “A-Z,” as she likes to be called. “For example, a centralized Institutional Review Board (IRB), discussed for years, is still in development, and ethical patient recruitment continues to flounder. The clinical part of the NIH “Alzheimer Budget Milestones” may need to be redrafted. I hope to create an accountable implementation team to get things done.”
One might ask, now that the National Institute of Health (NIH) may be funded at over $2B for the first time in AD [Cancer has almost $6B], and global funding in the UK, EU and China may be similar, how will the money be spent? Last year (FY 2017) NIH did spend $1.4B, lots of cool stuff from Big Data to nano-therapy ideas, lots of neuroimaging and genetics, but it’s a bit hard to discern the proportion spent on practical mature ideas or clinical trials that could help current patients.
An NIH blog piece from earlier this year (2018) was enthusiastic about Alzheimer clinical research, and stated: “While the number of awards depends… we expect to fund five to seven clinical trials. We anticipate a total of $10 million for fiscal year 2018 with future amounts depending on annual appropriations…The ACTC [Alzheimer Clinical Trial Consortium] is a “next-generation” infrastructure …and consists of 35 sites plus a coordinating center and 10 units staffed with teams to manage areas such as biomarkers, clinical operations, … and recruitment.”
“Let’s compare the ACTC to cancer’s National Clinical Trials Network (NCTN),” suggested Dr. A-Z. “The NCTN is said to have 2000 sites organized in five major networks, and 30 leading academic sites, with shared centralized resources. The overall NCTN budget is $151 million, and is said to help enroll 17,000 patients on dozens of interventional trials a year. Cancer has had a Centralized IRB since 2001. OK, in FY 2014 Alzheimer’s disease was budgeted only $415M, and the NCTN was built over decades, so we better get started to catch up!” she said.
“And I’m well aware of all the hard brilliant work done since 1991 by the Alzheimer Disease Cooperative Study Group (ADCS). But this new funding creates an opportunity to really forge ahead, test empiric drug repurposing ideas on a comprehensive scale, put to rest all the Cochrane methodology issues in older Alzheimer trials, and also move forward with impactful studies to at least improve quality of life for those afflicted, and their families. While we would love to help find disease-modifying agents, rigorously testing combinations for associated agitation or apathy are also important,” she stated.
When asked about the “Precision Medicine” initiatives in Alzheimer’s disease and dementia, Dr. A-Z had this to say: “I’m all for basic research, and I’ve personally seen how monoclonal antibodies and manipulated immune systems can combat leukemia, for instance. But the bulk of effective cancer therapy is not “precise,” and has been curing patients for decades. The discovery and clinical impact of that strategy for neurodegenerative disease may take awhile, and there are plenty of things we can do and try, here and now, to try to help patients in our lifetimes.”
Graphics: from NIH AD Bypass Budget for FY2019: https://www.nia.nih.gov/sites/default/files/2017-07/FY19-bypass-budget-report-508_0.pdf, also NIH Bypass Budget 2017 https://www.nia.nih.gov/sites/default/files/2017-07/reaching-for-a-cure-alzheimers-disease-and-related-dementias-research-at-nih.pdf