Several years ago, my organization planned to conduct studies in Therapeutic Plasma Exchange (TPE), which has been around and FDA-approved for many decades. Neurologists first began to prescribe TPE in the 1970s and 80s for neurological disorders such as Myasthenia gravis, a chronic neuromuscular disease, and Guillain-Barré syndrome, in which the body’s immune system attacks part of the peripheral nervous system.
When I first met and interviewed Gloria Simpson, who now serves as Chief Nursing Ops for the Young Blood Institute (YBI), she told me of the TPE treatments she and her colleagues had performed as a part of the Grifols AMBAR® studies in Florida to treat moderate-stage Alzheimer’s patients with plasma exchange. Grifols had just published their study results, but they did not publish a remarkable finding.
Findings from Grifols’s studies
Gloria told me that while she worked on the study, treating Alzheimer’s patients with TPE, she witnessed some patients recover their memories. I hired her on the spot, realizing she understood which control arm of the study contained the patients who recovered their memories, as well as the finer nuances of the study implementation procedures.
Today, Gloria leads the nursing team at the YBI, which has conducted further studies identifying the effect of TPE on Amyloid βeta (Aβ) protein fragments, which form plaque in the brain that impairs cognition in Alzheimer’s pathologies. YBI discovered that 25% of cognitively normal subjects presented excessive levels of Aβ protein, indicating a higher-than-normal probability of cognitive impairment in the future.
Our studies, which have not been published, showed that destructive Aβ proteins within the brain can be effectively cleared preventatively. This eliminates much of the risk of Alzheimer’s development and provides a treatment for those already diagnosed that could slow the progression of the disease and even help some patients recover memories, as Gloria witnessed.
The Grifols study is a successful example of how plasma exchange therapy could be used with Alzheimer’s patients. Their published results showed a 61% reduction in the disease’s progression according to several markers, including the ADAS-Cog: Alzheimer’s Disease Assessment Scale — Cognitive scale and the ADCS-ADL: Alzheimer’s Disease Cooperative Study — Activities of Daily Living scale.
The findings of these studies were indeed remarkable, but Gloria has treated over 10,000 patients with apheresis in her career, and her observations gave me additional faith in the potential to help tens of millions of people at risk of this dreaded disease. My aunt passed away from Alzheimer’s disease, and many people know someone who has or knows someone with Alzheimer’s.
I have also introduced Gloria to many MDs and scientists over the years, and very few have actually heard that memory recovery is possible with TPE. Each time someone meets Gloria and hears about her experience, they react with a sense of hope and insight into the possibilities for the future of Alzheimer’s care.
A commercialized treatment in Spain
Nonetheless, I had always wanted to hear directly about the AMBAR study experience in Spain, responsible for about half of the approximately 500 subjects. I had the opportunity to meet Dr. Mercè Boada of the ACE Alzheimer Center in Barcelona recently for dinner at the American Society For Apheresis conference in Las Vegas. Gloria couldn’t make the conference due to personal conflicts, so I did a FaceTime with her when I met with Dr. Boada for dinner.
Dr. Boada may be the first person I ever introduced Gloria to who was not surprised by her stories of patients recovering their memories — she sees it every day. Since the conclusion of the AMBAR studies in 2018, Dr. Boada and her colleagues have been actively treating Alzheimer’s patients from all across Spain. Hundreds of patients travel to Barcelona for diagnosis and treatment each month.
Not all patients respond the same way to TPE treatments, but Dr. Boada confirmed that many do and that they have effectively commercialized TPE treatments for Alzheimer’s in Spain. Now, it is time for America to do the same.
Commercializing Alzheimer’s treatment in the U.S.
The studies conducted by YBI and Grifols both demonstrate the practical use of an existing therapy to treat a horrible disease. Spain has created a commercial business around the use of TPE to treat Alzheimer’s disease.
However, it begs the question: why don’t more people know about this? The answer, in my opinion, is that there is an abundance of “noise” in the system.
For example, Grifols spent roughly $150 million over 14 years to achieve a 61% success rate in the patients they studied with Alzheimer’s or symptoms showcasing an onset of the disease. Yet according to a March 2024 report from the Alzheimer’s Association, “The annual Alzheimer’s and dementia research funding by the federal government will be as much as $3.8 billion.” In other words, the research business is an industry unto itself, and $150 million over 14 years is but a drop in the bucket.
More than enough federal funding is spent each year on researching a cure for Alzheimer’s, but as the commercial results in Spain demonstrate, a practical therapy exists in our midst. As the saying goes, “Sooner or later, everything old is new again,” and that is certainly the case with TPE, which has entered a new renaissance of scientific discovery and medical application.
The U.S. is nearly 20 times the size of Spain geographically, so we can’t expect people from around the U.S. to fly to a single location as they do in Spain. We formed AmβARI Healthcare to commercialize a mobile platform that enables us to deliver TPE services to any local private care clinic in the U.S. within a matter of weeks, making TPE accessible and practical for millions of people. We think of it as “Uber for Alzheimer’s” — a simple, turnkey system patients and their local MDs or neurologists can access easily and quickly.
Mark Urdahl
Mark Urdahl is Chairman & CEO ofYoung Blood Institute.
