Doctors at the Cleveland Clinic Lou Ruvo Center for Brain Health have a grim message to share with the public: We’re not doing enough to develop drugs to battle Alzheimer’s disease.
The center set out this year to analyze all clinical trials of drugs tested on Alzheimer’s patients in the United States. The researchers' findings: only 244 drugs have been tested in the past decade. The failure rate for Alzheimer’s drugs awaiting approval was 99.6 percent between 2002 and 2012, the Ruvo Center found.
“This is a kind of shock; we really have to reconsider this because the failure rate is unacceptably high,” said Dr. Jeffrey Cummings, director of the center’s clinical trials. “We’re simply not meeting the challenge. We’re going to have to invest much more into the drug development process.”
The study, which surveyed data from ClinicalTrials.gov, a government website that records clinical trials, aimed to examine historical trends to try to understand why efforts to develop treatments for Alzheimer’s disease so often have failed.
That’s vital information, considering there are an estimated 5.3 million people with the disease worldwide. Scientists expect that number to balloon to 16 million by 2050.
Cummings hopes the study will highlight a dire need for attention for the disease and research dollars.
A common foe of Alzheimer’s research has been the process. Releasing any kind of medicine — especially drugs for Alzheimer’s — takes lots of time and money. From dreaming up a drug to testing it in clinical trials to getting it approved by the Food and Drug Administration, the process typically takes 12 years and $2 billion. The last time a new Alzheimer’s drug hit the market was 2003.
“What we found was that the investment in (Alzheimer’s disease) drugs and therapies is relatively low compared to the challenge posed by the disease,” said Dr. Kate Zhong, the Ruvo Center’s senior director of clinical research. “The pipeline is almost dry.”
Going forward, doctors at the Ruvo Center hope to shift their focus on testing alternative methods of treatment for Alzheimer’s. The center already has begun testing drugs approved for other diseases and ailments, such as bexartene, a skin cancer drug, on Alzheimer’s patients.