Rhode Island Hospital’s Alzheimer’s Disease and Memory Disorders Center, led by Jonathan Drake, associate director, recently was in the news for their participation in the new Clarity AD study looking at a new experimental infused treatment for Alzheimer’s disease called BAN2401. They are enrolling patients as part of the battle against Alzheimer’s disease.
What is BAN2401?
BAN2401 is an experimental drug that is currently in clinical trials for the treatment of Alzheimer’s disease. It is a humanized version of a mouse antibody mAb158 that recognizes protofibrils and prevents amyloid beta deposition in animal models of Alzheimer’s disease. As reported by the sponsor, Eisai and Biogen, BAN2401 may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Eisai obtained the global rights to study, develop, manufacture and market BAN2401 for the treatment of Alzheimer’s disease pursuant to an agreement concluded with BioArtic in December 2007. By March 2014, Eisai and Biogen entered into a joint development and commercialization agreement.
This experimental drug, as reported by Barbara Morse with NBC 10 News is similar to another experimental drug targeting Alzheimer’s disease called aducanumab, a human monoclonal antibody sponsored by Biogen. Back in October 2019, Biogen announced that it would be re-starting the FDA approval process for aducanumab, starting that new analysis of a larger dataset revealed that the experimental drug reduced clinical decline in patients with early Alzheimer’s disease when given at higher doses. There has been controversy over this move and many are skeptical.
Interestingly the first drug approval for Alzheimer’s in decades—in China—took the world by surprise and fascination. Many have questions but the drug is coming to clinical trials in America.
Known as Clarity AD, the study started in the spring of 2019 and runs till March 2024. The study is conducted to evaluate the efficacy of BAN2401 in participants with early Alzheimer’s disease (EAD) by determining the superiority of BAN2401 compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. The study will also evaluate the long-term safety and tolerability of BAN2401 in participants with EAD in the Extension Phase and whether the long-term effects of BAN2401 as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase.
The sponsors, Eisai and Biogen, are targeting the enrollment of 1,566 patients at 154 sites in North America, Europe, Japan and Korea. Rhode Island Hospital is one of these sites participating in this important Phase III trial.
Rhode Island Hospital Principal Investigator Discussion
Dr. Jonathan Drake, associated director, is the leading principal for the trial. He told NBC 10 News “We are currently enrolling for the Clarity study” and noted to the local television channel that BAN2401 and aducanumab essentially target the same thing stating “They target the protein called amyloid, which is thought to be one of the earliest, if not the earliest, manifestation of changes in the brain that eventually lead to clinical Alzheimer’s disease.” Breaking things down Drake continued “What it is, it takes advantage of a biological tool that all of our bodies have, called antibodies. These are basic flags that the immune system produces to mark things in the body that don’t belong there.”
Drake elaborated on the study drug “We infuse this anti-amyloid protein into the blood and it flags amyloid for removal by the immune system. This is for patients who are 50 to 90 who have what we call mild cognitive impairment or mild Alzheimer’s disease and its an 18-month stud, participants will come in twice per month for an infusion.”
Rhode Island Hospital’s Alzheimer’s Disease and Memory Disorders Center
The Alzheimer’s Disease and Memory Disorders Center at Rhode Island Hospital offers a full range of diagnostic and treatment services, including brain imaging, genetic testing and neuropsychological evaluation. Eisai and Biogen elected to include this center for Clarity AD as it is nationally known for not only its clinical services but also for its research—including clinical trials program that offers the latest in leading-edge new therapies aimed to treat and also delay, and ultimately prevent the symptoms of Alzheimer’s disease.
The Alzheimer’s Disease and Memory Disorders Center emphasizes on its website that as there are 70 different causes of dementia, a comprehensive diagnostic evaluation is an important first step when dealing with symptoms of memory loss.
Rhode Island Hospital
Rhode Island Hospital is a private, not-for-profit hospital located in the Upper South Providence neighborhood in Providence, Rhode Island. It is the largest academic medical center in the region, affiliated with Brown University since 1959. As an acute care teaching hospital, Rhode Island Hospital is the principal provider of specialty care in the region and the only Level I Trauma center in southeastern New England. The hospital provides a full range of diagnostic and therapeutic services to patients, with particular expertise in cardiology, including the state’s only open-heart surgery program; diabetes, emergency medical and trauma, neurosciences, oncology/radiation oncology, orthopedics, pediatrics, and surgery. Rhode Island Hospital’s pediatrics division, Hasbro‘s Children’s Hospital, is the only pediatric facility in the state. Recording nearly 154,000 visits in the fiscal year of 2016, Rhode Island Hospital’s adult and pediatric emergency wings are among the busiest in the United States.
Together with Miriam Hospital, Rhode Island Hospital is a founding member of the Lifespan health system.
Dr. Jonathan Drake, associated director, Rhode Island Hospital’s Alzheimer’s Disease and Memory Disorders Center
Call to Action: Do you or a loved one have an Alzheimer’s diagnoses or concerned about aging and memory loss and live in Rhode Island? If so, you may want to consider a visit to Rhode Island Hospital’s Alzheimer’s Disease and Memory Disorders Center. Need support navigating the administrative elements of this study? Feel free to contact TrialSite News.