Two R.I. hospitals involved in global trial that found effective drug against early Alzheimer’s

PROVIDENCE – Scientists at two Rhode Island hospitals were part of a global clinical trial that proved a new drug can slow the decline of patients with Alzheimer’s disease.

Butler Hospital’s Memory and Aging Program and Rhode Island Hospital’s Alzheimer’s Disease and Memory Disorders Center were among the research sites that participated in Clarity AD, the clinical trial led by pharmaceutical companies Eisai Co. Ltd. and Biogen, which found that a treatment with the drug lecanemab could reduce cognitive decline among people with early signs of the disease by 27% at 18 months.

“The results of the Clarity trial represent an important step forward in the fight against Alzheimer’s disease,” said Dr. Stephen Salloway, founder of the Memory and Aging Program at Butler Hospital 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 [Food and Drug Administration] and the Center for Medicare and Medicaid Services.”

Tokyo-based Eisai has submitted an application for early approval to the FDA and the agency is expected to make a decision by Jan. 6.

“The announcement of the efficacy of lecanamab – a form of amyloid immunotherapy – is very encouraging,” said Dr. Chuang-Kuo Wu, director of the Alzheimer’s Disease & Memory Disorders Center at Rhode Island Hospital. “As one of the participating sites of this ongoing drug study, we at Rhode Island Hospital hope that this trial will lead to a new therapeutic option for patients with Alzheimer’s disease. We look forward to sharing updated information with our patients and study participants as we await the complete study data in December and results of the FDA approval and CMS coverage decisions later in 2023.”

The two hospitals are now enrolling participants for another study of lecanemab, called the AHEAD study, which is exploring whether the drug is able to maintain cognitive abilities in people between the ages of 55 and 80 who are not diagnosed with Alzheimer’s disease.

The Clarity AD trial also made efforts to recruit diverse ethnic and racial populations, resulting in approximately 25% of the total U.S. enrollment, including Hispanic and African American people experiencing early Alzheimer’s disease.

Salloway said diversity in clinical research is important and has been a focus of the Aging Program at Butler Hospital.

“We really need to have a broad community of participation in our research. Given the overall societal inequities, as well as health care 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,” Salloway said. “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.”

Claudia Chiappa is a PBN staff writer. You may contact her at Chiappa@PBN.com.