A major Alzheimer’s disease-focused study is cautiously proceeding despite the COVID-19 pandemic. Sponsored by pharmaceutical company Eisai Inc., in collaboration with Biogen, the Alzheimer’s Clinical Trials Consortium, and the National Institute on Aging (NIA), this study investigates whether the investigational product called BAN2401 is superior to placebo to change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at select trial stages and whether BAN2401 is superior to placebo in reduction of brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at key milestones.
The Study Drug
BAN2401 is the humanized Ig1 version of the mouse monoclonal antibody mAb158, which selectively binds to large, soluble Ab protofibrils. This was developed by the biotech firm BioArtic Neuroscience (Artic) following the discovery of the “Artic” mutation in APP, which progresses to a form of clinically type Alzheimer’s disease marked by high levels of Ab protofibrils and a relative absence of amyloid plaques.
Eisai licensed the early-stage investigational product from Artic, and in 2014 both Eisai and Biogen entered into the joint development of this therapeutic antibody.
The study (NCT04468659) started recently and runs through until October 2027. A total of 1,400 participants are targeted for the entire trial.
Funded by the National Institutes of Health and several non-profit organizations, as well as Eisai, the company makes the investigational treatment used in the study. The study is coordinated by the University of Southern California’s Alzheimer’s Therapeutic Research Institute, Brigham and Women’s Hospital, Massachusetts General Hospital, and Harvard Medical School.
Other trial site locations associated with the study’s Clinicaltrials.gov disclosure include the University of South Florida Health; Byrd Alzheimer Institute in Tampa, FL; the University of Kentucky in Lexington, KY; and Butler Hospital Memory and Aging Program in Providence, RI. According to a recent NPR article, other trial sites are involved, such as the Institute for Memory Impairments and Neurological Disorders at the University of California, Irvine.
Study Safety Precautions
Due to COVID-19, trial sites have implemented rigorous safety measures, reports NPR. For example, UC Irvine now includes a long list of safety measures involving everything from daily screenings for medical staff to spacing site visits to avoid overlaps and crowding to use personal protective equipment, reports Jon Hamilton with NPR.
Hamilton reports that given ethnic minorities have been hit far harder by COVID-19, it’s harder to enroll them for this study even though Alzheimer’s studies also need more minority participation.
Paul Aisen, MD, Director Alzheimer’s Therapeutic Research Institute
Reisa Sperling, MD, Professor of Neurology, Harvard Medical School; Director, Center for Alzheimer Research and Treatment, Brigham and Women’s Hospital and Massachusetts General Hospital
Keith Johnson, MD Professor of Radiology, Harvard Medical School; Director of Molecular Neuroimaging, Massachusetts General Hospital