September 18, 2018
A new drug showed promise in both reducing the plaques that build up in the brains of those with Alzheimer’s disease and in slowing the progression of memory loss and other symptoms. The drug is only in mid-stage testing and further research in larger numbers of people is needed to confirm the findings. But it does suggest that new and more effective treatments may be on the horizon for a disease that affects more than 5 million Americans and more than 40 million worldwide.
The findings are important because current drugs for Alzheimer’s disease may ease symptoms for a few months but do nothing to stop the relentless downward progression of disease. The new drug being tested showed promise in both lowering brain plaques and possibly slowing progression of disease.
The experimental drug, called BAN2401 and made by the drug companies Biogen and Eisai, is given as an injection every two weeks. It is not yet available to consumers, pending more extensive testing. More results are expected in 2019.
For the study, presented at the Alzheimer’s Association annual conference, researchers enlisted 856 men and women from the United States, Europe and Japan. All had either mild Alzheimer’s disease or mild cognitive impairment, a brain disorder that often progresses to full-blown Alzheimer’s. In those early stages of disease, patients might, for example, become confused at times and forget people’s names.
All the study participants had brains with high levels of plaques in the brain. The plaques, a hallmark of Alzheimer’s disease, are formed when the toxic protein beta-amyloid clumps together in the brain.
The researchers found that of those people who got the highest dose of the drug, 81 percent showed dramatic drops in beta-amyloid levels in the brain. Tests of memory and thinking skills showed that their disease was 30 percent slower than those who were getting a dummy drug used as control in this kind of studies.
Experts said that the results, even if confirmed, are by no means a cure for Alzheimer’s. But slowing progression of disease in someone with early Alzheimer’s could mean that patients would be able to carry out everyday activities like getting dressed and preparing meals far longer.
Patients getting the second highest drug dosage also showed less beta-amyloid buildup and cognitive improvements, though they were not as dramatic.
The study was a Phase 2 trial, which is designed to test for both the efficacy and safety of a drug. People seemed to tolerate the new drug relatively well, with less than 10 percent of participants having side effects. None were serious.
But many drugs have shown early promise in Phase 2 trials, only to disappoint in larger Phase 3 trials. Because further testing is needed in large numbers of people, it would likely be years before, and if, the new drug would be available in pharmacies.
The drug, an antibody, works by attacking beta-amyloid at an early stage, before it begins to clump together.
Other new drugs are also undergoing testing, but none have yet been proven to slow progression of Alzheimer’s. Scientists still don’t understand why Alzheimer’s occurs, and basic research into the underlying causes is needed so that effective new treatments can be developed.
The last time the Food and Drug Administration approved a drug for Alzheimer’s was in 2014, and that was for a drug that combined two existing drugs. Before then, the last time a new drug came on the market was in 2003. None of the drugs currently approved for Alzheimer’s slow progression of the disease.
By ALZinfo.org, The Alzheimer’s Information Site. Reviewed by Marc Flajolet, Ph.D., Fisher Center for Alzheimer’s Research Foundation at The Rockefeller University.
Source: Eisai pharmaceuticals. Presented at the Alzheimer’s Association annual conference, July 25, 2018.