The Alzheimer’s Clinical Trials Consortium (ACTC) has announced 2 studies of combination therapy of elenbecestat (Eisai, Woodcliff Lake, NJ) and BAN2401(Eisai, Woodcliff Lake, NJ and BioArctic, Stockholm, Sweden) for potential prevention of Alzheimer’s disease (AD). The ACTC was formed with funding from the National Instute on Aging (NIA).
In the A3 study, participants without cognitive impairment or elevated amyloid levels who are at risk for amyloid-baccumulation will be randomly assigned to receive elenbecestat alone (2 doses being tested) or placebo. Elenbecestat is a b-amyloid cleaving enzyme (BACE) inhibitor, and this study will test whether treatment with a BACE inhibitor can slow amyloid accumulation at this early stage of AD. Accumulation of tau using positron emission tomography and cognitive changes will also be measured.
In the A45 study, participants without cognitive impairment and with elevated amyloid-blevels will first be treated with BAN2401, a monoclonal antibody to amyloid-bprotofibrils with the goal of clearing excess amyloid deposits from the brain. Next, participants will be treated with elenbecestat with the aim of decreasing production of amyloid-band preventing reaccumulation of amyloid plaques and protofibrils.
Trials will be starting early 2020. Individuals who may be interested in participating in these trials may sign up for additional information at .
Dr. Paul Aisen, Director of the University of Southern California Alzheimer's Therapeutic Research Institute, which serves as the coordinating center for the ACTC, noted that "The mission of the ACTC includes the development of public-private partnerships to conduct trials of promising candidate therapies. This collaboration with Eisai will allow us to test 2 promising therapies in innovative studies that may advance the field."
Jennifer Robblee, MD, MSc; Amaal J. Starling, MD; Rashmi B. Halker Singh, MD, FAHS, FAAN; and Nina Riggins, MD, PhD
Vanessa Baute Penry, MD; Rachana Gandhi Mehta, MD; and Fatemeh Sadeghifar, BS
James Geyer, MD, and Paul Cox