Elizabeth “Ann” Alderson can’t cook, clean or read books like she used to, but seven years after her Alzheimer’s diagnosis, she’s still able to carry on conversations, make jokes and enjoy life with her family.
Ann and her husband, Jay, who live in Phoenix, believe the progression of her disease has been slowed by a surgical implant she received at Barrow Neurological Institute that acts like a “pacemaker” for her brain.
Doctors at Barrow, part of Dignity Health St. Joseph’s Hospital and Medical Center in Phoenix, are hoping the implants will gain approval for widespread use in treating patients for Alzheimer’s disease, which is a progressive neurological disease with no cure.
Effective treatments for the disease remain elusive. Nearly 6 million Americans are living with Alzheimer’s.
Ann Alderson, who is 80, was one of 42 patients who were part of the pilot phase two portion of the clinical trial needed to get the treatment approved by the U.S. Food and Drug Administration.
The implants provide deep brain stimulation via a neurostimulator programmed to deliver an electrical current to select brain regions.
The aim and hope is to slow the cognitive and functional declines associated with Alzheimer’s disease.
“It’s a horrible disease but still livable for me,” Ann Alderson said Tuesday. “It’s important for people to know.”
The clinical trial has now moved into a five-year international phase three trial, which is one step before FDA review. And the first patient to be enrolled in the phase three trial at any of the 20 locations worldwide was enrolled in Phoenix at Barrow, officials announced Tuesday.
Research sites in the United States, Canada and Germany are aiming to enroll up to 210 patients in the trial.
“This is largest clinical trial of such a therapy in the world,” said Dr. Anna Burke, the principal investigator of the trial and director of Barrow’s Alzheimer’s and Memory Disorders Division. “Alzheimer’s disease is one of the greatest challenges that faces our society at this point. … We are very, very fortunate to be part of this study.”
Deep brain stimulation is not new. The delicate procedure has been used for years on certain patients with movement disorders such as Parkinson’s disease and essential tremor. Since it’s been so effective, it is now being explored as an option for other neurological conditions such as Alzheimer’s disease, Burke said.
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In Alzheimer’s patients, it is being used to target the fornix, which is a different area of the brain than in Parkinson’s patients, explained Dr. Francisco Ponce, director of the Deep Brain Stimulation Program at Barrow.
Doctors described the fornix as the “superhighway” of the brain.
It’s believed that targeting therapies at the fornix will slow neurodegeneration, or the wasting away of parts of the brain, Barrow officials say.
“We are looking at the brain as millions and millions of circuits that are all interconnected. And we’re looking to see how we can rewire these circuits in conditions such as Alzheimer’s disease, epilepsy, eating disorders like obesity, mood disorders such as depression, obsessive compulsive disorder, Tourette’s syndrome,” Ponce said. “This redirection of attention from degeneration of areas of the brain to looking at circuitry has been something made possible through the success of deep brain stimulation for Parkinson’s disease and for tremor.”
The phase two portion of the trial for Alzheimer’s patients had a goal of determining whether the procedure was safe, and the evidence showed that it is safe and was tolerated well by the patients. Brain scans also showed the implants had a benefit for patients’ cognition and function — results that Ponce called “clinically significant.”
The phase three trial will evaluate the safety and effectiveness of the deep brain stimulation treatment in patients over 65 years of age who have mild, probable Alzheimer’s. And the trial will test the hypothesis that the deep brain stimulation will slow cognitive decline related to Alzheimer’s, Barrow officials said.
“Phase three is a significant step forward in reaching that finish line in having something that’s available to the public that’s much needed,” Ponce said. “There’s an urgent need and there’s a need for a new strategy. Drug trials (to treat Alzheimer’s) have been slow to produce results, so we are excited to assess whether deep brain stimulation could offer hope for patients and their families.”
The randomized double-blind controlled trial will compare the effects of deep brain stimulation in patients whose “pacemaker” devices are turned on with approximately half in a placebo control group that are turned off. Neither patients nor the Barrow doctors will know whose systems are on or off.
The patients will undergo regular physiological, psychological and cognitive assessments for a year. At that time, all patients will have the chance to have their devices turned on.
Ann Alderson’s device was implanted in 2014, but was turned off for the first 12 months. Her family says they noticed a difference after it was turned on.
“When they turned the device on, within two weeks everyone who is in contact regularly with Ann noticed a difference,” Jay Alderson said. “I noticed that her cognitive abilities were improved — not dramatically, but noticeably.”
Though Ann Alderson can no longer read books, she still reads newspaper articles and likes to watch television. She was the one who first noticed her Alzheimer’s symptoms in 2012 when she started making mistakes in her job working at a book store.
Her symptoms progressed to where she began getting confused and had trouble following conversations. Tasks she once did easily like running the dishwasher and the washing machine became difficult.
Jay Alderson, her husband of 59 years, said the implant has not reversed the Alzheimer’s, but the family is grateful she was able to participate in the trial.
Ann said she did not hesitate when Burke told her about the possibility of getting an implant.
“I was excited to get it,” Ann said. “I was so happy. I wanted to jump on it right away.”
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