Clinical Trial for new Drug to Prevent Alzheimer’s Disease to Start in Japan

The Yomiuri Shimbun

An international joint clinical trial for a new Alzheimer’s drug developed by a Japanese pharmaceutical company will start in Japan as early as next month, The Yomiuri Shimbun has learned.

Eisai Co.’s drug BAN2401 will be administered to 1,400 people around the world with normal cognitive functions during the four-year clinical trial to examine the drug’s effects, according to sources. The candidate drug to prevent Alzheimer’s disease, the most common cause of dementia, is drawing global attention whether it can become a breakthrough as the disease is a challenge throughout the graying world population.

In Alzheimer’s disease, nerve cells are damaged and the brain shrinks. Mild cognitive impairment appears before the onset of the disease. In addition to memory loss, symptoms such as losing track of time and place can occur.

The disease is said to account for 60-70% of all dementia cases. The number of people worldwide with dementia is currently 50 million, but this figure is estimated to exceed 150 million by 2050. In Japan, the number of people who will develop dementia by 2025 is estimated at 7.3 million.

The clinical trial is led by the Alzheimer’s Clinical Trials Consortium, which was founded with funds from the National Institutes of Health in the United States. Japan, the United States, Canada, Australia, Singapore and some nations in Europe are the places chosen for the trial.

Alzheimer’s disease develops when brain cells are damaged by the gradual accumulation of a protein, called amyloid beta (Aβ) in the brain 10 to 20 years before symptoms appear. The BAN2401 drug is said to work by removing the protein from the brain.

People ages 55 to 80 who have Aβ accumulation but are asymptomatic will be eligible to participate in the clinical trial. They will be divided into two groups. During a four-year period, members of one group will be given an intravenous drip that includes the drug once every two to four weeks, while those of the other group will be given a placebo IV drip to compare Aβ accumulation, changes in cognitive functions and other points among the two groups.

In the United States, clinical testing for the drug started in September. In Japan, dozens of people are expected to participate.

Clinical trials for drugs to eliminate the protein have been conducted in various countries on people who have already developed Alzheimer’s disease, but these have failed in succession. The analysis was that drugs administered after brain cells have been damaged and the onset of symptoms showed no therapeutic effects, even with the elimination of the protein.

Based on this analysis, the current clinical study targets people before the onset of Alzheimer’s disease.

In Japan, the University of Tokyo, the National Center for Geriatrics and Gerontology and other entities are seeking healthy people to participate in the clinical trial and are cooperating in research to track the progress of participants through the possible onset of dementia.

“It is groundbreaking for Japan to fully participate in such a major international clinical trial with asymptomatic people,” said Takeshi Iwatsubo, a professor at the University of Tokyo and an expert on Alzheimer’s disease. “If effects of the drug are confirmed, the drug could be approved in Japan around the same time as in Europe and the United States, paving the way for use in medical practice.”