WVU Neurosciences, NICU nurse, undertake first-ever Alzheimer’s treatment trial

MORGANTOWN — Judy Polak is a pioneer.

The retired WVU NICU – neonatal intensive care unit – nurse was diagnosed with Alzheimer’s disease in 2014.

She’s the first person in the world to undergo a clinical trial of a new procedure that uses ultrasound waves to perhaps slow or even reverse the effects of early state Alzheimer’s.

“I think for me it won’t be anything,” she said. “It’s going to be the future.”

WVU’s Neuroscience Institute is conducting the trial, overseen by Executive Chair Dr. Ali Rezai, who explained the process.

In Alzheimer’s, as brain tissue degenerates, it’s inundated with plaques— protein deposits and other debris. This make the brain “sticky,” so it can’t communicate with the neurons, he said.

Something called the blood-brain barrier protects the brain by preventing toxins or large molecules from crossing through the blood vessels into the brain.

But in Alzheimer’s it’s self-defeating because it also prevents small molecules – medications, chemotherapy, antibodies – from crossing in to break up the plaques.

Rezai’s team is using a new-technology ultrasound helmet with 1,022 probes in it, combined with magnetic resonance imaging (MRI) to deliver focused, low intensity ultrasound waves that converge like a lens to a focal point to target the affected area: the hippocampus.

The hippocampus, he said, is involved in memory – and the plaques in dementia and Alzheimer’s affect new, working memory formation.

The helmet is called Exablate Neuro, developed by an Israeli company called Insightec. It and has been used to treat other conditions, such as tremors, with high intensity ultrasound. This is a trail of a new use for the machine.

“We’re among the few in this country that has access to this technology,’ Rezai said. Insightec chose WVU to be the first to undertake the Phase II trial after previous, successful Phase I preclinical trials on animals.

The process requires no incisions into the brain. As the ultrasound waves enter the brain, the surgical team injects a solution of microbubbles into blood stream.

These bubbles circulate through the brain; the ultrasound wave oscillates the microbubbles, which temporarily opens the blood-brain barrier. They believe the immune system is then activated and antibodies can pass into the brain to break up the plaques.

This should to some degree restore memory and improve affected behaviors, Rezai said.

Rezai leads a team of about 50 people. “What I’ve been stuck by is the dedication, the expertise of the people here, who are really coming together to explore some of these new opportunities, and really make the Rockefeller Neurosciences Institute and West Virginia University a premier place, the go-to place for discovery and innovation.”

Polak had two treatments in October and will receive one more. “She is really a very brave lady,” he said.

Meanwhile, researchers are enrolling more patients for trials at several sites around the country, Rezai said. They will see if there’s impact on plaques and cognitive memory loss.

“If we show that over the next two, three years, then there will be another trial, a much larger Phase III trial.”

Judy’s entire procedure takes about five hours. Her head has to be shaved to allow the ultrasound waves to pass. She is lightly sedated because the procedure involves some pain.

A metal “halo” is attached via screws with sharp points (they don’t go in far) and a silicon membrane is secured over the halo and the scalp. This is all secured to the ultrasound helmet’s specifically designed transcranial transducers.

This in turn creates a sealed space, which holds icy cold water. The circulating water provides a medium for smooth ultrasound transmission. Judy is lying on an MRI table for the duration of the procedure.

Judy’s husband, Mark Polak, is a NICU physician and learned about the trial via some co-workers. They made contact to volunteer in August and were soon approved.

Judy said she doesn’t feel the screws but does feel the cold. “It’s like being in a time capsule or something. … I have warm blankets, so it’s not so uncomfortable with that. It’s not so bad.”

What’s important for her, she said, is future Alzheimer’s patients. “As more and more people study this and put all the puzzles together, we’re going to find something that will help move forward.”

Their daughter, Emily Polak, is an administrative assistant in the pediatric research unit. “She’s just always been her throughout it,” she said. “She never looks nervous. She’s sitting up and still smiling.”

And she tries to help the nurses. “She’s still being a nurse even though she’s the patient. She’s pretty strong. And just seeing go through that without being sorry for herself … It’s never been about her.”

Then Emily tears up. “To me, if this trial can give us another hour where she’ll remember our names in the future, then it’ worked.”

Mark said, “Looking at it as a realist – we were not looking for cure. But the optimist in me says, why not?

“Maybe just opening that blood-brain barrier makes a difference. It made a difference in mice.”

The immune system may go to work and take care of the plaques. “Maybe people have noticed just a slight, subtle change in her eyes, the way she walks, a more stable gait. Not memory. That’s still is an issue.”

Alzheimer’s is a disease with 100 percent mortality, Mark said. The brain is protecting itself … while it destroys itself.

“Nobody gets out of this alive. This [trial] is jumping out of the box. Perhaps immune system will start ramping up in a  way it never has before.

He pondered the use of terms associated with disease. People always suffering from Alzheimer’s. People with cancer are fighting. “We’ve got to start picking up our weapons and fighting Alzheimer’s rather than just suffering from it.”

The Neuroscience Institute will follower Judy closely for five years, he said. They’ll do lab studies, blood tests, spinal taps to see if bad proteins have gotten out of brain, and “scans galore. She’ll have a free pass to the MRI.

There will also be neurologic testing – having her draw a circle, a square. One of her biggest problems is spatial orientation, he said.

“We would still be happy doing this if there was no change at all and we knew there was no possibility of improvement, because it has to be done.