The Alzheimer Society of Ireland (ASI) has welcomed the results of a clinical study that has signaled a potentially significant breakthrough in the treatment of Alzheimer’s disease.
The ASI described the data from the phase III clinical study on the efficacy of the lecanemab antibody in slowing the progression of Alzheimer’s disease in people with early-stage Alzheimer’s disease as “positive results”.
However, the study also found that the drug may put certain patients at risk of serious side effects. Lecanemab was linked to a dangerous type of brain swelling in nearly 13 percent of patients in the study, which lasted 18 months and included nearly 1,800 participants with early-stage Alzheimer’s.
The evidence was presented earlier this morning by representatives from Japanese pharmaceutical company Eisai at the annual Clinical Trials in Alzheimer’s Disease (CTAD) conference in San Francisco. The latest results follow encouraging top-line results released by Eisai and Biogen in September.
Lecanemab was shown to moderately slow the progression of Alzheimer’s disease, meeting the study’s primary endpoint. Lecanemab is an antibody that targets a harmful protein in the brain called amyloid beta.
Eisai has applied for accelerated regulatory approval from the FDA. A decision is expected in early January, with regulatory submissions in Japan and Europe to follow by the end of March 2023.
There are currently an estimated 64,000 people with dementia in Ireland and by 2045 this number is expected to rise to 150,000.
In response to the results, Dr. Laura O’Philbin, ASI Research and Policy Manager, said that lecanemab is the “most credible treatment option” for mild cognitive impairment and early Alzheimer’s disease that the world has seen “after decades of work.”
“While the clinical benefit seems small from a scientific perspective, this is a critical development and brings hope to people concerned about dementia around the world,” she said.
“It is a long way. Regulatory approval and developments in our healthcare system are needed before lecanemab can potentially be offered to people in Ireland. The Alzheimer Society of Ireland looks forward to continued collaboration with our research and clinical colleagues, as well as government officials.”
“This is a positive day and it’s just the beginning of a better future in dementia,” she added.
But leading dementia advocate Helen Rochford Brennan, who has lived with Alzheimer’s for 11 years, said that while she “welcomes” news of advances in treating the disease, she has concerns about the possible “side effects”.
The phase III study also found that some patients experienced bleeding in the brain, with five suffering from macrobleeds and 14 percent suffering from microbleeds – a symptom linked to two deaths of people receiving the drug in a follow-up study .
Ms Rochford Brennan has participated in research projects by ASI and Alzheimer’s Europe and stressed the importance of combining “psychosocial interventions” with medication.
“It’s important that I get out and walk the dog every day, it’s important that I do brain exercises, it’s important that I stand up for advocacy that requires me to talk to people like you and me bring in,” she said.
“Also, it’s important that I learned something new… I learned through Covid when we were so disadvantaged how to use technology.
“So a drug along with psychosocial interventions could really improve my quality of life.”
Speaking on RTÉ radio, Ms Rochford Brennan said she suffered a “minor setback” when she suffered a stroke two months ago, but is doing “pretty well” brain-wise.
She added that people with Alzheimer’s face high medical costs in Ireland and argued that the state should do more to help them with treatment costs.
Additional coverage from Reuters.
https://www.independent.ie/irish-news/health/alzheimers-charity-welcomes-promising-treatment-breakthrough-42185976.html Alzheimer’s charity welcomes ‘promising’ treatment breakthrough