University of Southern California (USC) Alzheimer’s Therapeutic Research Clinic (ACTC) is launching a clinical trial with the hopes of slowing or even stopping Alzheimer’s disease. The research is led by ACTC director Paul Aisen who initiated this research in San Diego over three decades ago and linked with UCSC four years ago. This large-scale clinical trial represents decades of research from scientific collaboration worldwide.
Attacking Amyloid Early
Aisen reports that the most recent research focus, according to 10 News, centers on how to alter or prevent the disease or for that matter “significantly slow its progression.” 10 News reports that Aisen believes it involves “attacking amyloid early” represent the highest potential at this point in time.
The Worldwide Clinical Trial
The study centers on the experimental drug called BAN2401 which is delivered intravenously. The drug is designed to bind to the sticky amyloid. This binding neutralizes beta amyloid and supports identifying it so that the immune system can recognize it and work to clear it from the brain.
Participants will receive BAN2401 for four years. In a related USC-sponsored, no-cost-to-the-participant study participants can track their memory performance over time. Eligible participants have a “first crack” at upcoming Alzheimer’s prevention trials. A web-based study, it can be accessed any where a participant has access to the internet. The participant takes two memory and thinking assessments—and then retake them again—for every three months. Some participants will be requested to submit saliva samples which can be done via the mail. This can help the sponsors discover new ways to predict future cognitive decline.
USC is seeking participants over 50 who haven’t yet evidenced symptoms of Alzheimer’s disease but have been assessed with greater amount of amyloid accumulation in their brain. The researchers can assess via a PET can or spinal tap the levels of amyloid.
What is BAN2401
BAN2401 is an experimental drug that is currently in clinical trials for the treatment of Alzheimer’s disease. A humanized version of a mouse antibody mAb158, it recognizes protofibrils and prevents amyloid beta deposition in animal models of Alzheimer’s disease. Eisai is the drug’s developer.
It is the result of a strategic alliance between Eisai and BioArtic. Biogen and Eisai entered into a joint development agreement for BAN1 2401 in 2017.
BAN2401 has been tested in two Phase I clinical trials including NCT012330853 and NCT02094729 to assess its safety, tolerability and pharmacokinetics. In one of these trials, the results revealed that BAN2401 was reasonably safe and well-tolerated at various doses.
In an ongoing Phase II trial (NCT01767311)—the Study 201—it is being examined for effectiveness at various intravenous doses in addition to safety and tolerability. With the initial trial at 18 months, it has followed-up with a current extension. The results of this effort in 858 patients reveal overall positive data points with statistically significant 30% decrease in cognitive decline and according to the sponsor, Eisai, lower accumulation of beta-amyloid in the brain as compared to those patients on a placebo.
The Phase III Clarity AD clinical trial (Eisai and Biogen) is now underway for the testing and efficacy of BAN2401 (10 mg/kg drug every two week) vs. a placebo in people with mild Alzheimer’s disease. This 18-month trial will be followed-up with a long-term, open-label extension phase, seeking to recruit 1,566 patients split equally between experimental treatment and control group. The reported endpoint (goal) of the study includes changes from baseline in the Clinical Dementia Rating—Sum of Boxes (CDR-SB). Changes in other cognitive testing, such as ADCOMS as well as the AD Assessment Scale-Cognitive Subscale (ADAS-cog) and beta-amyloid levels assessed by PET—this clinical trial is planned to conclude in March 2024.
Call to Action: If you or a loved one may be concerned about Alzheimer’s disease you may want to consider connecting with USC to discuss participation. See the link for more information at USC. Also, consider reviewing the USC Alzheimer’s Therapeutic Research Clinic website.