Butler Hospital, Among the Study Sites, Now Enrolling for Additional Study to Determine Drug’s Ability to Prevent Alzheimer’s
On Tuesday, September 27, 2022, pharmaceutical companies Eisai Co., Ltd. And Biogen Inc. announced the results of the Clarity AD clinical trial, a global, Phase three confirmatory trial of the drug lecanemab (BAN-2401) for the treatment of early Alzheimer’s disease (AD). Topline results showed a highly statistically significant reduction in clinical decline among patients with early AD who were administered the drug. Butler Hospital’s Memory and Aging Program (MAP) and Rhode Island Hospital’s Alzheimer’s Disease and Memory Disorders Center are among the research sites that carried out the Clarity AD study and are currently enrolling participants for another study of lecanemab, called the AHEAD Study.
“The results of the CLARITY trial represent an important step forward in the fight against Alzheimer’s disease,” said Stephen Salloway, MD, MS, founder of the Memory and Aging Program at Butler Hospital and Martin M. Zucker Professor of Psychiatry and Human Behavior, Professor of Neurology, and Associate Director of the Center for Alzheimer’s Disease Research at Brown University.
“The study is the first completed pivotal trial to show amyloid-lowering and clear clinical benefits providing new hope for patients dealing with early stages of the disease. We are very proud of the role that Rhode Islanders played in making this advance possible, and we eagerly await the release of the full study data and the review by FDA and the Center for Medicare and Medicaid Services.”
In a press release issued by Eisai and Biogen, the companies announced that lecanemab treatment reduced clinical decline by 27% at 18 months, as measured by CDR-SB, a numeric scale used to quantify the various severity of symptoms of dementia. The treatment showed highly statistically significant changes in CDR-SB from baseline starting as early as six months.
Eisai will discuss this data with regulatory authorities in the U.S., Japan and Europe with the aim to file for traditional approval in the US and for marketing authorization applications in Japan and Europe by the end of Eisai’s FY2022, which ends March 31, 2023.
Also of note is the high degree of diversity achieved in the Clarity AD trial, a critical goal for Alzheimer’s research because BIPOC populations are 1.5 to 2 times as likely to develop the disease compared to whites, and yet are underrepresented in most studies.
Eisai’s recruitment strategy for the Clarity AD clinical trial ensured greater inclusion of ethnic and racial populations in the U.S., resulting in approximately 25% of the total U.S. enrollment including Hispanic and African American persons living with early AD. Due to the inclusive eligibility criteria and the successful recruitment of diverse ethnic and racial populations in the U.S., Clarity AD’s population is generally comparable to the country’s Medicare population.
Dr. Salloway underscored how important diversity in clinical research is, saying that the Memory and Aging Program at Butler Hospital has undertaken significant efforts to increase diversity across all of its clinical trials.
“We really need to have a broad community of participation in our research. Given the overall societal inequities as well as healthcare inequities that people of color have experienced, it takes considerable effort to build those partnerships and the trust that will lead people of diverse backgrounds to participate in clinical research. We’re fully committed to that effort. It’s not only the right thing to do, but it is only through having a really robust group of study volunteers that we are going to make progress in fighting this disease,” Dr. Salloway said.
While the Clarity AD trial was focused on reducing clinical decline in individuals already diagnosed with early AD, the AHEAD study seeks to establish whether lecanemab is superior to a placebo in maintaining cognitive abilities in people between the ages of 55 and 80 who currently have normal cognitive function. The study will also evaluate how effective the drug is in reducing levels of amyloid and tau plaques in the brain associated with the development of AD.