Vibhor Krishna reviews a brain image of a patient with Alzheimer’s disease (Ohio State University)
7 May 2019. A clinical trial is testing focused ultrasound waves guided by MRI scans to penetrate the blood-brain barrier and clear toxic proteins from the brain. The study, conducted at Ohio State University in Columbus and other institutions, is assessing a technology developed by the company Insightec in Haifa, Israel as a treatment for Alzheimer’s disease.
Alzheimer’s disease is a progressive neurodegenerative condition, the most common form of dementia affecting growing numbers of older people worldwide. People with Alzheimer’s disease often have deposits of abnormal substances in spaces between brain cells, known as amyloid-beta proteins, as well as mis-folded tangles of proteins inside brain cells known as tau. Centers for Disease Control and Prevention says as many as 5 million people in the U.S. were living with Alzheimer’s disease in 2014, with deaths from Alzheimer’s increasing 50 percent from 1999 to 2014.
The Insightec technology uses high-resolution magnetic resonance imaging, or MRI, to guide the delivery of ultrasound waves to converge on a target in the body, then quickly heat and burn off, or ablate, the target tissue. Non-converging ultrasound is safe in the body and widely used for medical imaging, such as sonograms showing babies in the womb. Insightec developed a special form of its technology called Exablate Neuro, a non-invasive technique for use in the brain. FDA cleared Exablate Neuro as a treatment for essential tremor, a condition causing involuntary shaking of the hands, somewhat similar to Parkinson’s disease.
In the trial, researchers at Ohio State led by neurosurgery professor Vibhor Krishna, are testing Exablate Neuro to penetrate the blood-brain barrier as a way to gently and temporarily penetrate the blood-brain barrier, enabling the body’s immune system to help clear the accumulated toxic proteins on nerve cells. The blood-brain barrier is a support network for brain functions, with tightly-packed cells lining blood vessels that allow nutrients to pass through, but keeping out foreign substances. This barrier also keeps out drugs to treat neurological conditions, such as Alzheimer’s disease.
“Our hypothesis is that, by opening the blood brain barrier, a patient’s own immune defense may clear some of those harmful amyloids,” says Krishna in a university statement. “If we determine this to be safe, in the next steps we would want to understand the effectiveness and the impact of opening the blood-brain barrier in improving cognitive decline.” In November 2017, Science & Enterprise reported on the start of a similar trial testing Insightec’s technology to penetrate the blood-brain barrier to help treat glioblastoma, a brain cancer.
The clinical trial is enrolling 10 individuals with early signs of Alzheimer’s disease at Ohio State, Weill Cornell medical center in New York and West Virginia University in Morgantown. Participants will be treated with MRI-guided focused ultrasound, wearing special helmets that stabilize and shoot ultrasound waves through the skull. The ultrasound beams stimulate microscale bubbles in the brain’s blood vessels to oscillate and penetrate the blood-brain barrier.
Participants will receive 3 treatments, with each treatment 2 weeks apart. The study team is looking primarily at the safety of the focused ultrasound, tracking adverse effects from the treatments for up to 5 years. The researchers will also use MRI to look for signs that the blood-brain barrier was disrupted, but later closed in the 24 hours following treatment.
Krishna tells more about the study in the following video, as well as introduces a participant in the trial.
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