PROVIDENCE — Rhode Island is once again playing a critical role in the development of promising potential treatments for Alzheimer’s disease.
A new experimental drug by Eli Lilly and Co., called donanemab, modestly slowed symptoms over 18 months — some of the best early results seen by pharmaceutical researchers from a mid-stage study. The company published details of the study in the New England Journal of Medicine this past weekend.
Another investigational drug, aducanumab, developed by Cambridge, Mass.-based Biogen Inc., was also studied recently and is up for review by the Food and Drug Administration. A decision on whether to approve the drug is expected by June.
Both drugs were studied at the Memory and Aging Program at Butler Hospital, owned by the Care New England Health System, and at the Alzheimer’s Disease and Memory Disorders Center at Rhode Island Hospital, owned by Lifespan Corp., the state’s largest health care system. Both hospitals are affiliated with the Warren Alpert Medical School of Brown University.
Donanemab works by targeting the amyloid plaque and tau protein buildup in the brain, which is associated with the development of Alzheimer’s disease and other forms of dementia.
According to the Phase II study of donanemab, called TRAILBLAZER-ALZ, patients with early Alzheimer’s showed that the drug slowed decline by 32 percent on a composite measure of cognition and daily function when compared to a placebo.
Dr. Stephen Salloway, director of the Memory and Aging Program at Butler Hospital, said that as both a clinician and researcher, he’s encouraged by the significant plaque lowering and the slowing of clinical decline with donanemab. He said the Phase II study results are an “encouraging milestone.”
Eli Lilly announced the findings Saturday at the International Conference on Alzheimer’s & Parkinson Disease 2021 in tandem with the publication of the NEJM article.
“In the last twelve months we’ve seen significant advancements in diagnosing and treating Alzheimer’s,” said Salloway, who is a professor of psychiatry and human behavior and of neurology at Brown’s Medical School. “With this kind of momentum we are on the verge of important breakthroughs for Alzheimer’s disease.”
Salloway, who is also the coauthor of the NEJM article, was the principal investigator for the TRAILBLAZER study at Butler and was a lead investigator on the trial. The study was conducted at 61 research sites across the United States and Canada, including the two sites in Rhode Island.
Various other drug candidates have been designed to target amyloid plaque but have generated confusing results, as did Biogen’s, or negative results. But researchers say that Lilly’s results appear to be more straightforward, with clear-cut data.
The study used tau Positron Emission Tomograhy (PET) imaging with flortaucipir tracer, which was developed specifically to detect the tau protein in the brain. These tracers were developed by the Memory and Aging Program at Butler in partnership with the Alzheimer’s Disease and Memory Disorders Center at Rhode Island Hospital.
Salloway was the lead study clinician through all development phases of the tracer.
“The immediate goal is to provide treatments that will slow cognitive impairment in people experiencing the early stages of Alzheimer’s disease,” Salloway said. “At the same time we’re also testing treatments to prevent or delay memory loss in people at risk.”
Dr. Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories, said in a statement Monday that the company has dedicated more than 30 years to finding solutions for Alzheimer’s, in diagnostics and in treatment.
“We’ve created a set of tools that allows us to see and measure brain pathology directly, and this has unlocked new ways to conduct trials, which we believe is the path forward for continued progress in Alzheimer’s disease,” Skovronsky said.
This latest clinical trial enrolled 272 patients who were selected based on cognitive assessment. A larger trial is next.
“We are on the cusp of a watershed moment in Alzheimer’s disease treatment that could change the lives of millions of people around the world,” Salloway said.