A father-of-three who was diagnosed with Alzheimer’s at 56 years old is taking part in a new clinical trial that may be able to slow the disease’s effects.
David Shorr, now 59, is one of 10 patients testing an ultrasound cap at The Ohio State University Wexner Medical Center and two other sites.
The device uses ultrasound waves to open the blood-brain barrier and targets an area of the brain where dangerous levels of two rogue proteins can build up and lead to dementia.
Researchers hope that after opening the barrier, the body’s immune system may clear proteins from the brain, and that they may even be able to directly deliver medication to the site of the disease.
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David Shorr, of Bexley, Ohio, was diagnosed with Alzheimer’s disease at age 56. Pictured: Shorr, left, completing a jigsaw puzzle with his wife, Kim
He is now part of a new clinical trial testing an ultrasound cap at The Ohio State University Wexner Medical Center and two other sites. Pictured: Shorr undergoing testing
An estimated 5.7 million Americans of all ages are currently living with Alzheimer’s disease.
According to the Centers for Disease Control and Prevention, that number will rise to around 14 million over the next four decades.
The progressive brain disorder slowly destroys memory, thinking skills and the ability to perform simple tasks, and there is no cure.
Those who have Alzheimer’s have a build-up of two proteins, amyloid beta and tau, in the brain that form clumps, which smother and destroy neurons – leading to loss of memory and confusion.
Shorr, of Bexley, Ohio, is among the four percent of people who are diagnosed before age 65.
Several past clinical trials from pharmaceutical companies have failed to provide results that their drugs can slow Alzheimer’s progression.
Between 1998 and 2017, there have been almost 150 unsuccessful attempts to develop Alzheimer’s drugs, according to science news website BioSpace.
AstraZeneca plc, Biogen Inc, Eli Lilly, Johnson and Johnson, Merck and Co Inc, Pfizer Inc, and Roche AG were all testing drugs – but all failed or ended after safety concerns.
The cap uses ultrasound waves and microbubbles to open the blood-brain barrier, which protects the brain from infection. The barrier also makes it difficult to deliver medications to the brain, which may explain why other trials have failed. Pictured, left and right: Shorr
Researchers hope opening the blood-brain barrier will help the body’s immune system break down the build-up of proteins that smother neurons, causing memory loss and confusion. Pictured: Shorr, sitting taking part in the trial, with his wife, Kim, standing by
But the new clinical trial from Wexner Medical Center uses ultrasound waves to cross the blood-brain barrier, the layer of blood vessel walls that protects the brain from foreign objects.
‘While it’s protective and beneficial for day-to-day brain function, when we think about therapeutics, the blood-brain barrier poses a significant challenge,’ said Dr Vibhor Krishna, a neurosurgeon at Ohio State Wexner Medical Center.
Because the walls are so tightly bound together, it’s extremely difficult to deliver medications to the brain, which may explain why other trials have failed.
‘The focused ultrasound procedure allows us to non-invasively access the brain tissue so treatment can be administered straight to the site of pathology,’ said Dr Krishna.
Shorr’s wife, Kim, remembers getting the call to participate in the clinical trial.
‘[They said]: “There’s this trial. Would you be interested?”‘ she said. ‘And without really knowing what it was, we said: “Sure”.’
First, Shorr’s head is shaved. Next, a head frame is secured so his head will remain still.
A cap that is attached to head frame delivers ultrasound waves and microbubbles to open the blood-brain barrier.
Another alternative is that opening the blood-brain barrier will help deliver drugs directly to the site of the disease. Pictured: Shorr walks his dog near his home
Currently, an estimated 5.7 million Americans of all ages are living with Alzheimer’s, and that number is expected to rise to around 14 million over the next four decades. Pictured: Dr Vibhor Krishna (right) fits Shorr with a helmet-like device used in the new clinical trial
This step, Phase 1, will determine if opening the blood-brain barrier is possible, if it’s safe, and if the barrier will close after being opened.
According to WebMD, Shorr has undergone three sessions and, each time, the blood-brain barrier has closed on its own in just a few hours.
Phase 2 will see researchers testing if the body’s immune system clears out proteins on it own, or if they can deliver medicine straight to the brain after opening the blood-brain barrier to hopefully treat Alzheimer’s.
‘In this research study, we are not delivering any medications. Our hypothesis is that, by opening the blood brain barrier, a patient’s own immune defense may clear some of those harmful amyloids,’ said Dr Krishna.
‘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.’
Shorr said he is thankful to be part of the study, even if it doesn’t treat his condition.
‘You can help other people as you go by and they follow up.’ he said.
His wife Kim added: ‘We’re hopeful it can help him, but we also know maybe it will help somebody else.’