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alzheimer's drug trials failure rate

Alzheimer’s Drug Trials Have Had a 99% Failure Rate. The Good News: There Are Currently More Than 100 in the Pipeline

By Phil Gutis | July 30th, 2020

A survey of all drugs currently in clinical trials for Alzheimer’s disease found 121 unique therapies being tested in 136 Alzheimer’s drug trials. That promising finding, however, comes with not only a high failure rate, but a warning that not enough people with cognitive problems are volunteering to participate in the trials.

The paper was published in the journal Alzheimer’s & Dementia: Translational Research & Clinical Interventions by lead researcher Jeffrey Cummings of the University of Nevada, Las Vegas.

In the paper, Cummings found:

— Of the 121 drugs in clinical trials, 29 are in Phase III trials, 65 are in Phase II trials and 27 are in Phase I safety trials. 

— Of the 121 drugs in clinical trials, 12 target cognitive enhancement and 12 are intended to treat neuropsychiatric and behavioral systems. 

— In the last five years, researchers have continued to diversify their research away from the amyloid plaque thesis that has dominated the field for decades. Researchers are now looking at treatments targeting inflammation and vascular factors among others.

— Researchers are also studying an increasing number of drugs that have won prior government approval for non-Alzheimer’s disease treatments and are being repurposed for Alzheimer’s. These repurposed drugs now account for 43 percent of the drugs currently being tested for Alzheimer’s. Among the repurposed drugs are Metformin, Losartan and Candesartan.

“We’ve never seen more promise in the pipeline than there is today,” Cummings said in a news release. “We are going to solve this problem.”

Standing in the way, however, is the lack of patients willing to participate in research. Cummings estimated that 31,314 people are needed for currently recruiting Alzheimer’s drug trials. 

“Patient participation is critical and recruitment is too slow, challenging and expensive,” Cummings said. “We need our ‘citizen scientists’ because they are contributing in such an important way to a future without Alzheimer’s disease.”

This is the second survey of the Alzheimer’s drug pipeline that Cummings has published. In 2014, according to the news release, he found a 99 percent failure rate for all test therapies in the pipeline at the time. And to date, the field has not been more successful.

“Since our original publication in 2014,” Cummings said, “we have yet to have a successful drug move across the finish line.”

One reason for optimism, Cummings said, is the recent discovery of biomarkers — measurements such as blood tests that can reveal very early symptoms of cognitive disorders. 

“The very recent discovery of relevant biomarkers allows us to develop drugs with a precision we’ve never had before,” Cummings said.

Of the trials currently in the drug development pipeline, Cummings found that 46 percent are sponsored by the drug industry and 39 percent by academic medical centers. 

The paper highlighted two drugs that have made the most progress:

Oligomannate, a seaweed extract, won approval in China for improvement in cognition with patients with mild-to-moderate Alzheimer’s disease. It has not been approved by the FDA for use in the United States.

Aducanumab, an amyloid treatment, has a request for approval pending before the FDA. Developed by Biogen and Eisai, aducanumab has had a controversial and twisted path with the companies originally cancelling the trial after aducanumab failed to pass a “futility test.”

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