Release Date: 9/22/2020 

The first infusion of an investigational drug that aims to slow the earliest memory loss due to Alzheimer’s disease took place earlier in September at Butler Hospital in Providence, R.I., researchers announced.

Funded by the National Institutes of Health (NIH) and Japanese drug manufacturer Eisai, Inc., the AHEAD Study is the first Alzheimer’s disease prevention trial to recruit people as young as 55 years old and who do not carry a mutation that predisposes them to the disease. It introduces a personalized medicine approach that tailors treatment dose levels based on a study participant’s particular risk of memory loss related to Alzheimer’s disease.

“We know that changes in the brains of people with Alzheimer’s disease begin up to 20 years before a person notices symptoms, but until now clinical trials have only included older patients much later than these symptoms appeared,” said Reisa Sperling, MD, director of the Center for Alzheimer’s Research and Treatment at Harvard Medical School and lead researcher for the AHEAD Study. “By inviting younger participants, we hope to help individuals who are at higher risk—such as people of color or those with family history—get ahead of the disease with early intervention.”

The AHEAD Study is made up of two different clinical trials testing the same investigational drug (known as BAN2401). Participants are enrolled in one of the two trials based on the level of amyloid in their brain. Amyloid is a protein that builds up in people who can go on to have memory problems and develop Alzheimer’s disease. The trial is led by experts at the University of Southern California’s Alzheimer’s Therapeutic Research Institute, the Alzheimer's Clinical Trials Consortium, Brigham and Women’s Hospital, Massachusetts General Hospital, and Harvard Medical School.

“The personalized approach that treats people years before memory loss has begun has the potential to be a breakthrough in Alzheimer’s prevention,” said Stephen Salloway, MD, MS, and director of the Memory and Aging Program at Butler Hospital. “This new tailored approach can potentially serve as a model to improve clinical trials in Alzheimer’s research and other diseases.”

The sixth leading cause of death in the United States, Alzheimer’s is the only disease among the top 10 causes of death that cannot be prevented, cured, or slowed. Currently, 5.6 million Americans 65 and older are living with Alzheimer’s and this number is expected to nearly triple by 2050. Communities of color experience higher incidence of the disease than White communities, yet they remain underrepresented in clinical research.

“Both of my parents were diagnosed with Alzheimer’s disease and I have the gene. I can’t run away from that but I can help find a treatment,” said Dave Kalberer, recipient of the first AHEAD infusion at Butler Hospital. “I’m proud to be at the front of the line for this exciting opportunity and am hopeful this trial can change not just my life but millions more.”

The AHEAD Study seeks 1,165 participants from North America. The study has more than 100 study locations worldwide, including North America, Japan, Singapore, Australia, and Europe.

About Butler Hospital

Butler Hospital, a member of Care New England, is the only private, nonprofit psychiatric and substance abuse hospital serving adults, seniors and adolescents in Rhode Island and southeastern New England. Founded in 1844, it was the first hospital in Rhode Island and has earned a reputation as the leading provider of innovative psychiatric treatments in the region. The Major Affiliated Teaching Hospital for Psychiatry and Behavioral Health at The Warren Alpert Medical School of Brown University, Butler is recognized worldwide as a pioneer in conducting cutting-edge research.