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Researchers at Rhode Island Hospital’s Alzheimer’s Disease and Memory Disorders Center (ADMDC) are currently recruiting Citizen Scientist® volunteers for multi-center Phase III clinical trial of an anti-amyloid antibody, BAN2401, for patients with early Alzheimer’s disease. BAN2401 works by selectively targeting toxic forms of amyloid-beta in the brain, a hallmark of Alzheimer’s disease. The drug has been shown to significantly reduce amyloid-beta plaques in the brain. This investigational agent is being jointly developed by Eisai and Biogen, leading companies in the field.
Many previous clinical trials of investigational agents that targeted reduction of brain amyloid have not succeeded; however, Biogen’s recent decision to pursue FDA approval for aducanumab, another anti-amyloid antibody, has rekindled enthusiasm in this class of investigational drugs. Last year, Eisai and Biogen published promising results of a Phase IIb study of BAN2401 in early Alzheimer’s disease that reported 30% slowing of cognitive decline with the highest dose of BAN2401, compared with a placebo at 18 months.
Amyloid plaques in the brain can be seen by using a special type of brain scan called an amyloid Positron Emission Tomography (PET) scan. Only people with elevated levels of amyloid plaques on their PET scan will qualify to participate. In this study, BAN2401 will be given intravenously twice a month for 18 months. While this is a placebo-controlled study, after completing the 18-month study, all participants will be given the option to receive the actual study drug. Every person joining this study must have a study partner who is able to come to some of the study visits.
Jonathan Drake, M.D., associate director of the Alzheimer’s Disease and Memory Disorders Center and principal investigator for the BAN2401 study shared, “This latest anti-amyloid drug shows real promise to be a key component of treatment to combat Alzheimer’s disease. With the news about Biogen’s plans to pursue regulatory approval for aducanumab, we feel that big developments are on the horizon in Alzheimer’s treatment. Individuals with Alzheimer’s disease should consider participation in research as part of their overall care and treatment plan.”
Interested volunteers should contact recruitment specialist Terry Fogerty at the Rhode Island Hospital Alzheimer’s Disease and Memory Disorders Center at 1-844-5MEMORY or by email at firstname.lastname@example.org.