In 2018, approximately 5.7 million Americans are living with Alzheimer’s dementia, a number that is expected to double within the next 30 years. Alzheimer’s disease causes memory loss, mood changes, and eventually difficulty speaking, swallowing, and walking. Currently, no medication exists that can slow or stop the progression of Alzheimer’s disease and no new treatments have been approved by the FDA in more than 15 years.
On July 25th, Eisai Co. Ltd. and Biogen Inc. presented positive results from a Phase 2 clinical trial testing the new Alzheimer’s drug BAN2401. The trial included 856 patients with mild Alzheimer’s disease who received the drug, which targets a protein called β-amyloid. When β-amyloid folds into the wrong shape, it sticks together and forms plaques around neurons, blocking their ability to communicate. BAN2401 binds to the components of these plaques and promotes their clearance.
Twelve months into the treatment, the drug initially produced disappointing results; however, at 18 months, 161 patients (those receiving the highest dose) showed a reduction in amyloid plaques. These patients also exhibited a 30% slower cognitive decline, making BAN2401 the first drug to improve brain function. There are caveats to consider: Patients with a gene called APOE4, which has been associated with accelerated cognitive decline, were excluded from this treatment group due to a predisposition to drug-induced brain swelling. This prompts us to question whether the drug will be effective in all patients. We are both excited —and cautious— as we await the Phase 3 clinical trial results.
Managing Correspondent: Jeremy Gungabeesoon
Clinical Trial (National Institute on Aging/National Institutes of Health):
Photo Credit: Image courtesy of National Institute on Aging, National Institutes of Health, U.S. Department of Health and Human Services.