new Alzheimer's disease treatment The first human trials showed potential.
researchers west virginia university The Rockefeller Neuroscience Institute (RNI) has discovered that a combination of focused ultrasound and antibody therapy can accelerate the removal of amyloid beta plaques from the brains of Alzheimer's patients.
The study results were published in the New England Journal of Medicine on January 11th.
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Abnormal accumulation of amyloid beta proteins is one of the hallmarks of Alzheimer's disease, as these proteins clump together to form plaques that block neurons in the brain.
Anti-amyloid β monoclonal antibody antibody treatmentDrugs such as aducanumab and lecanemab have been shown to be effective in removing these plaques and slowing the progression of the disease.
An Alzheimer's disease patient receives focused ultrasound treatment by the WVU RNI team. (Rockefeller Neuroscience Institute (RNI) at West Virginia University (WVU))
But until now, the drug has been limited by the blood-brain barrier (BBB), which prevents harmful substances from reaching the brain, according to an RNI press release.
“Studies like this are important because they demonstrate that there may be a safe way to increase drug delivery to the brain without serious adverse effects.”
More than 98% of the drug is blocked by the barrier, meaning patients will require higher doses and more frequent treatments, the researchers noted.
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In this study, the scientists used a focused ultrasound (FUS) system to temporarily open the blood-brain barrier, allowing antibodies to gain further access to areas of the brain with high amyloid-beta plaques.
6 months later antibody treatmentstudy participants experienced an average 32% greater reduction in amyloid beta plaques in areas where the BBB was open compared to areas where the drug was used without ultrasound, the release states.
The WVU RNI team, shown in the control area of the MRI suite, plans an ultrasound blood-brain barrier treatment. (Rockefeller Neuroscience Institute (RNI) at West Virginia University (WVU))
“This is the first three-participant human safety and feasibility study to demonstrate that opening the BBB can enhance the clearance of beta-amyloid plaques.” Dr. Ali Rezai, principal investigator and director of WVU's Rockefeller Neuroscience Institute (RNI), told Fox News. Digital.
“Non-invasive focused ultrasound is an outpatient procedure that allows targeted delivery of therapeutics to the brain and may accelerate the effectiveness of antibody treatments in Alzheimer's disease,” he added. .
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The three patients were between 59 and 77 years old and all had mild Alzheimer's disease.
During the study, they received six monthly infusions of the aducanumab antibody.
After each treatment, focused ultrasound was used to open the BBB in areas with the most plaque buildup.
There are some potential risks to using ultrasound, such as swelling and bleeding in the brain, but these effects were not observed in this study, Rezai said.
A focused ultrasound helmet unit with 1,024 ultrasound transducers is mounted on the MRI table for MRI-guided treatment. (Rockefeller Neuroscience Institute (RNI) at West Virginia University (WVU))
“We confirmed in the MRI scan that the BBB opening was temporary and closed within 24 to 48 hours after the FUS procedure,” he told FOX News Digital.
The reduction in amyloid plaques was confirmed by PET scan.
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This was the first step in a large-scale study. These studies will allow researchers to evaluate more patients and wider brain regions, Rezai said.
The next phase of clinical trials will combine ultrasound therapy with lecanemab, another anti-beta amyloid antibody.
This 3D illustration shows how ultrasound waves from inside the helmet converge to a focal point on the brain that is used to open the blood-brain barrier. (Rockefeller Neuroscience Institute (RNI) at West Virginia University (WVU))
Dr. James Galvin, director of the UHealth Brain Health Comprehensive Center at the University of Miami Health System, was not involved in the WVU study but shared his reaction.
“Studies like this are important because they demonstrate that there may be safe ways to increase drug delivery to the brain without severe adverse effects,” he told FOX News Digital. Ta.
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“Focused ultrasound is also used in other treatment paradigms for brain diseases such as Parkinson's disease and brain tumors,” Galvin continued.
Galvin also cautioned that the study was conducted on just three patients and was not a placebo-controlled study.
As of 2023, an estimated 6.7 million Americans age 65 and older will have Alzheimer's disease. (St. Petersburg)
“This was also designed as a safety study and was not adequately powered to detect significant clinical changes,” he added. “While it is still too early to make specific recommendations, we look forward to seeing if follow-up studies with more patients are planned.”
Dr. Rebecca M. Edelmeyer, senior director of scientific engagement at the Alzheimer's Association, who was not involved in the study, also called the results, while preliminary, “very interesting.”
“The blood-brain barrier, in healthy conditions, protects the brain from harmful substances that can reach the brain through the bloodstream,” she told FOX News Digital via email.
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“Delivering therapeutics across this barrier, from the bloodstream to brain tissue, is a challenge for all drugs used to treat brain diseases, including those for Alzheimer's disease.”
Professor Edelmayer added that although this was a “very small study of relatively short duration”, it was a valuable way to test “cutting-edge ideas” for improving the effectiveness of Alzheimer's drugs. Ta.
This illustration of an MRI-guided focused ultrasound system includes a representation of the treatment delivery, target area, and corresponding opening of the blood-brain barrier indicated by contrast enhancement. (Rockefeller Neuroscience Institute (RNI) at West Virginia University (WVU))
Edelmeyer noted that blood-brain barrier opening induced by focused ultrasound has also been shown to improve drug delivery for treating brain tumors.
“This is a good example of how findings from research in other diseases can be repurposed for Alzheimer's disease and other dementias.”
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Looking to the future, Edelmayer said this initial research Large-scale, long-term clinical trials.
“Further research is needed in Alzheimer's patients from all communities to see what impact this approach has.”
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