Joe Walsh, 79, is poised for a potentially groundbreaking moment. Settled into a recliner at the Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital in Boston, he is about to receive an innovative treatment.
His wife, Karen Walsh, stands by, ready with a nasal spray applicator. At the count of three from a nurse, the spray is administered, and Walsh inhales deeply.
This nasal spray delivers a monoclonal antibody designed to mitigate inflammation linked to Alzheimer’s in Walsh’s brain.
Walsh is pioneering this treatment for Alzheimer’s, which is also undergoing trials for conditions like multiple sclerosis, ALS, and COVID-19.
Preliminary results, published in the journal Clinical Nuclear Medicine, suggest a reduction in Walsh’s brain inflammation.
“I think this is something special,” remarks Dr. Howard Weiner, a neurologist at Mass General Brigham who collaborated with Tiziana Life Sciences to develop the nasal spray.
It’s uncertain, however, if the inflammation reduction will enhance Walsh’s cognitive functions.
This experimental treatment is part of a broader initiative to disrupt the progression of Alzheimer’s disease in the brain.
Currently, two drugs on the market target amyloid plaques, toxic protein clusters between neurons, while other experimental drugs focus on tau tangles within nerve cells.
However, fewer treatments have addressed inflammation, an Alzheimer’s hallmark that intensifies as the disease advances.
A Diagnosis and a Quest for Care
Post-treatment, Walsh undergoes a cognitive evaluation by Dr. Brahyan Galindo-Mendez, a neurology fellow.
“Can you tell me your name, please,” Mendez inquires. “What’s your name?”
After a moment’s pause, Walsh responds with “Joe.”
“And who is with you today?” Mendez continues, gesturing towards Karen Walsh.
Walsh replies, “We’ll do that,” struggling to name his wife of 36 years.
Karen Walsh recalls noticing changes in her husband as early as 2017, citing his difficulty in finding words during conversations.
Following a primary care visit, Walsh was advised to enter a research study for Alzheimer’s treatment. A neurologist’s assessment in 2019 confirmed the diagnosis with a PET scan showing amyloid plaques.
Despite the shock, Karen Walsh was determined to pursue research opportunities. However, the COVID-19 pandemic halted many studies, and by the time they resumed, Walsh no longer met the criteria for most trials due to the disease’s progression.
A Novel Drug for Inflammation
In late 2024, Karen reached out to Dr. Seth Gale, a neurologist at Mass General Brigham, seeking a study for Joe.
Gale soon found a trial for Walsh involving foralumab, a monoclonal antibody tested for inflammatory diseases like multiple sclerosis.
In MS, the immune system attacks nerve fiber coverings, causing inflammation. Foralumab shows promise by inducing regulatory cells that reduce inflammation, Weiner explains.
Foralumab’s potential extends to conditions causing nervous system inflammation, including Alzheimer’s, a disease of personal interest to Weiner, who lost his mother to it.
Traditional Alzheimer’s treatments focus on clearing amyloid plaques and tau tangles. Increasingly, researchers are targeting inflammation, which worsens as the disease progresses.
Weiner notes, “Once people have Alzheimer’s, the inflammation is driving the disease more.”
Success in mice models encouraged Weiner’s team to seek FDA approval for Walsh under expanded access, allowing treatment for those outside clinical trials with no other options.
With FDA approval, Walsh became the first Alzheimer’s patient to receive foralumab. Six months later, his brain’s inflammation has markedly decreased, although damaged brain cells can’t be recovered.
While cognitive tests will determine any improvements in Walsh’s memory, his wife has observed increased social engagement.
“He still struggles with words,” Karen Walsh acknowledges, “but he’s more involved in social activities, and his friends have noticed.”
Walsh, content with the treatment, states, “It’s easy enough to take it, so I do it, and it feels good.”
A clinical trial of foralumab for Alzheimer’s is anticipated to commence later this year.
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