MORGANTOWN — WVU Medicine President and CEO Albert Wright may have been the least surprised when he learned a team from WVU’s Rockefeller Neuroscience Institute made history in the battle to find a cure for Alzheimer’s
“I was praying that our first patient would be safe,” Wright said. “This was a true team effort. In some ways that’s kind of like the team that puts a man on the moon, and I’ll always remember that moment.”
In October, the team of 35 medical experts, led by neurosurgeon and the project’s principal investigator, Dr. Ali Rezai, successfully performed a phase II trial using focused ultrasound to treat a patient with early stage Alzheimer’s.
“This study has given people serious hope,” Wright said. “Real problems are being solved in Morgantown, West Virginia.”
For their unprecedented efforts and success, and the potential impact it could have on thousands afflicted with dementia-like illnesses, the team of 35 medical experts has been named “West Virginians of the Year” by NCWV Media.
The breakthrough that Wright is so proud of — first reported in the Exponent Telegram and on WVNews.com — made history mainly because the WVU team combined the innovative ultrasound treatment with INSIGHTEC, an Israeli medical technology company.
Earlier this year, INSIGHTEC was approved by the U.S. Food and Drug Administration to begin a phase II clinical trial of the procedure, and selected the WVU Rockefeller Neuroscience Institute as the first site in the United States for that trial.
Last summer, researchers at Sunnybrook Health Sciences Centre in Toronto reported the results of a phase I safety trial showing they could reversibly open the blood-brain barrier in Alzheimer’s patients.
The procedure in West Virginia involved the use of ultrasound waves focused through a specialized helmet with more than 1,000 probes targeting a precise spot in the brain, Rezai explained, coupled with microscopic bubbles.
“And when we put a different frequency of ultrasound on the bubbles, they start oscillating,” Rezai said.
The reaction opened up the brain-blood barrier — a nearly impenetrable shield between the brain’s blood vessels and cells that make up brain tissue.
“It’s protected on one end for us to function, but also prevents larger molecules or chemotherapy or medications or antibodies or immune system cells or amino therapy or stem cells to get in,” he added.
In this case, the West Virginia team targeted the hippocampus and the memory and cognitive centers of the brain that are impacted by plaques found in patients with Alzheimer’s.
“Plaques are these clusters of proteins that accumulate and they block up the brain’s connectivity,” Rezai said. “In animal studies, it showed that these plaques are cleared with ultrasound technology.”
The first patient, a person both Rezai and Wright called a pioneer and hero, is West Virginia health care worker and former WVU Children’s Hospital Neonatal Intensive Care Unit nurse Judi Polak.
“I think that with Alzheimer’s there’s so much in the unknown, and I’ve been with Health Science for a long time and I understand that we need to be able to step forward and look into the future,” Polak said after she endured the first of three ultrasound trials, all a success.
The first procedure, which lasted three hours, safely and successfully opened her blood-brain barrier for a record 36 hours, said Mark Polak, Judi’s husband.
“It was opened longer than they expected,” Mark Polak said. “They were actually, I think, both excited and scared. The team was ecstatic.”
One member of the team Mark Polak mentioned is Dr. Jeff Carpenter, a professor of neurology, neurosurgery and an interventional neuroradiologist at WVU.
“This is really step one,” Carpenter said of the successful trial. “This is to make sure it’s safe and hopefully we can decrease some of the big plaques in that part of the brain.”
Carpenter is what he jokingly called the “technical guy” on Rezai’s team, with 18 years of experience working MRI technology and interventional radiology.
“It’s a combination of knowing MRI very well and also being used to actually treating patients,” Carpenter said. “This treatment marries MRI guidance with ultrasound targeting. It really uses all the things I’ve been working with.”
Carpenter, a native of Fairmont, credited Rezai’s work and ultimately the leadership at WVU Medicine for supporting the research needed.
“It is really nice to be able to do this level of work this close to home,” he added.
Another key member of the team was Dr. Marc Haut, chair of WVU School of Medicine’s Department of Behavioral Medicine and Psychiatry, a clinical department at the WVU Rockefeller Neuroscience Institute. He played a unique role on the team mainly because of his relationship with the Polaks.
“I was there for her because I knew Judi so well,” Haut said. “We had a long-standing relationship and that was comforting to her during the procedure.”
Along with helping the Polaks during the procedure, Haut also worked as a co-investigator to assist in, as he put it, “thinking through questions and programs that arise when you do this type of procedure for the first time.”
Haut, who’s been at WVU for nearly 30 years, said the day the trial took place was a humbling experience he will never forget.
“To be able to say after 30 years, ‘Wow, that was the best day in my professional career,’” he said. “To me, the most amazing thing about it is how well the team worked together. It was impressive.”
But as Rezai pointed out, the many members of the team who helped make the Alzheimer’s breakthrough a reality are also connected to a handful of similar medical research efforts. The most recent was in November when the nation’s first phase III clinical trial using a tiny, pill-like micropellet made of a non-addictive, non-steroid medication, placed in a patient’s lower back to combat chronic pain caused from sciatica.
“Lots of teams involved here, whether it’s addiction or Alzheimer’s; we’re working very hard for West Virginia to be a hub for discovery and rapid clinical trials,” he said. “There’s a critical need for developing novel approaches for the treatment and management of opioid uses and prevention and also Alzheimer’s. We want to develop solutions that come out of West Virginia.”
Dr. Richard Vaglienti, principal investigator on the randomized trial using a clonidine micropellet that is roughly half the size of a grain of rice, said it’s an exciting time to be at WVU Medicine.
“Having the opportunity to investigate new non-opioid treatments for sciatica and a range of pain conditions is directly aligned with the WVU Medicine Center for Integrative Pain Management’s mission to combat the opioid crisis in West Virginia and nationwide,” Vaglienti said.
Wright, who on Dec. 19 addressed an audience of more than 300 on the recent and anticipated success at WVU Medicine, said the recent accomplishments are part of a strategic goal moving WVU to a top 25 academic medical center status.
“They’re just getting started,” he added. “They (Dr. Rezai and many others) are attracting folks from all over the world to come here.”
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