Alzheimer’s Disease has been a perplexing medical puzzle for decades. Since it was first identified in 1906, scientists and medical experts have worked to find a way to detect the early stages of the disease, treat it at every stage, and eventually bring about a cure.
Recently, experts in the neurological space have explored emerging research that shows that Amyloid βeta (Aβ) levels play a significant role in the development of and progression of Alzheimer’s. Aβ is a protein fragment that has been shown to be a key player in the formation of plaque abnormalities found in the brains of Alzheimer’s patients.
While researchers once believed that Aβ proteins were only present in the brains of those with advanced Alzheimer’s Disease, recent studies now suggest that Aβ proteins can precede a diagnosis of Alzheimer’s by decades and that the detection and removal of such proteins can help stave off this devastating diagnosis. These findings have even led to a commercialized treatment for Alzheimer’s which is now available in Spain.
However, this begs the question: why isn’t the same commercialized treatment available in the US yet?
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The Grifols Study
Upon discovering the role that Aβ proteins play in early-stage or pre-diagnosed Alzheimer’s, many experts and scientists took to the lab to uncover ways to promote early detection and treatment. Mark Urdahl, CEO of AmβARI Healthcare, believes that studies conducted by pharmaceutical company Grifols could not only change the landscape for the early treatment and prevention of Alzheimer’s but also introduce a commercialized treatment for the condition.
The Grifols study looked at the effectiveness of Alzheimer’s Management by Albumin Replacement (AMBAR®) in a multimodal approach designed to slow the progression of the disease. The first step includes a therapeutic plasma exchange that flushes out damaging substances such as Aβ proteins. Then, fresh albumin, which is capable of capturing more Aβ proteins, is introduced to complete the therapeutic process.
Gloria Simpson, Chief of Nursing Ops for AmβARI Healthcare and the plasmapheresis manager for the Grifols study, saw firsthand the benefits of therapeutic plasma exchange.
“We treated nearly 200 patients in the Grifols study,” Simpson said. “For the patients that drew the optimal control arm in the study, I witnessed a number of Alzheimer’s patients recover their memories.” This recovery of memories is significant, as no other therapy has been able to make this claim.
Grifols reported that “In conclusion, after PE treatment with 5% human albumin of AD patients, a measurable modification in Aβ1–42 concentration in CSF and plasma was observed, with different patterns of mobilization. PE treatment was associated with improvement in memory and language functions compared to control group patients (sham PE), who showed the cognitive decline expected in AD.”
Shortly after Simpson completed the AMBAR study, she met Urdahl and told him of her unique results. He was immediately taken by her depth of knowledge and experience.
“Their research and results are due to decades of research and testing into the role that Aβ proteins play along every stage of Alzheimer’s, even pre-diagnosis,” Urdahl explains. “There aren’t very many medical professionals who have actually seen people recover their memories. Gloria is one of the very few medical professionals who ever witnessed memory recovery in Alzheimer’s patients.”
The Grifols study showed that plasma exchange therapy eliminated the risk for Alzheimer’s in those who are cognitively normal and significantly slowed the disease progression for those already diagnosed. While the recovery of memories for the study’s control group was a positive outcome, Simpson also witnessed those in the placebo group deteriorate at an alarming rate, as Grifols reported, which further drove home the importance of the study’s outcomes.
People needed to hear about the benefits of therapeutic plasma exchange and the availability of early detection of Aβ proteins, but despite its success, this treatment is still not particularly well-known. People like Simpson and Urdahl are left trying to find a way to get the word out.
“Why don’t people know about this?” Urdahl asks. “I believe it’s because there’s so much noise in the system. Even though Grifols spent $150 million over 14 years and had a 61% success rate with Alzheimer’s, it pales in comparison to the $3 billion worth of research the industry spends each year.”
Recovered memories
Simpson joined The Young Blood Institute (YBI) in 2018 to further her work in the area of plasma exchange for Alzheimer’s treatment. Through the YBI, Simpson continued studying the positive effects of plasma exchange therapy for cognitively normal patients whose testing showed an excess of Aβ proteins in their brains. In 2022, she brought what she had learned to AmβARI Healthcare, a commercial sister organization dedicated to commercializing YBI research findings and furthering the cause of plasma exchange for detection and treatment so clinicians bring this effective approach to patients.
Since working with Simpson, Urdahl has had the opportunity to meet with pioneering neurologist Mercé Boada of the ACE Alzheimer’s Center in Spain, who also confirmed clinical observations such as Simpson’s. This treatment has since been commercialized in Spain, and it is Urdahl and AmβARI Healthcare’s goal to expand this commercialization to the rest of the world.
AmβARI Healthcare solutions
Thankfully, Urdahl has plenty of experience commercializing technology and bringing innovative solutions like Simpson’s to the public. “Throughout my career, I have always curated ideas from brilliant people and translated them into products and services,” he asserts. “Here, we have a clear-cut case of something that works well enough. If they’re doing it in Spain, they can do it in the US.”
By building off the information from the Grifols study, AmβARI Healthcare guides patients through the steps of therapeutic plasma exchange following testing that may show that the patient has an excess of damaging Aβ proteins. Through AmβARI Healthcare’s proprietary platform called the Clinical Decision Support System (CDSS), doctors can accurately and efficiently assess the level of Aβ proteins in someone’s brain through PET/CT scans and blood tests.
Through the CDSS, results can be studied, and therapeutic plasma exchange can be prescribed. The CDSS also helps clinicians order needed nurses and equipment for the therapeutic plasma exchange, which AmβARI Healthcare offers as a turnkey service platform to fly nurses, equipment, and pharmaceuticals to clinics anywhere in the country to treat patients under the supervision of their own doctor or neurologist. In the near future, the platform will become available throughout the world.
“So many people in the research world have never taken their ideas to market, opting for endless research, and now we’re at a point where they’re doing this in Spain as a commercial business,” Urdahl explains. “We have people who saw people recover their memories, which a scant few in the entire Alzheimer’s research industry can even say that they’ve ever seen. We want to make these therapies available to people in need.”