Analysis of Clinical Trials Shows Pipeline for Therapeutics is
Small; 99.6 Percent of Drug Attempts Fail
EMBARGOED UNTIL 12:00 a.m. ET, THURSDAY, July 3, 2014, Las Vegas: Researchers at the Cleveland Clinic Lou Ruvo Center for Brain Health have conducted the first-ever analysis of clinical trials for Alzheimer's disease (AD), revealing an urgent need to increase the number of agents entering the AD drug development pipeline and progressing successfully towards new therapy treatments. The paper, "Alzheimer's Disease Drug Development Pipeline: Few Candidates, Frequent Failures," was published today in the journal Alzheimer's Research & Therapy.
A comprehensive look at all clinical trials underway shows:
· There are relatively few drugs in development for Alzheimer's disease.
· The failure rate for AD drug development is 99.6 percent for the decade 2002-2012.
· The number of drugs has been declining since 2009.
"Our goal was to examine historical trends to help understand why Alzheimer's disease treatment development efforts so often fail," said Jeffrey L. Cummings, M.D., ScD, Director of the Cleveland Clinic Lou Ruvo Center for Brain Health. "With an estimated 44 million people living worldwide with the condition, the study shows that the Alzheimer's disease drug development ecosystem needs more support given the magnitude of the problem."
Using the advanced search mechanisms of ClinicalTrials.gov, a government website that records all ongoing clinical trials, Dr. Cummings, along with Kate Zhong, M.D., Senior Director of Clinical Research and Development, and Touro University medical student Travis Morstorf, constructed a comprehensive analysis to examine all trials since 2002.
"By analyzing both completed as well as on-going trials and currently active compounds, we were able to provide insight into longitudinal trends in drug development," said Dr. Zhong. "What we found was that the investment in AD drugs and therapies is relatively low compared to the challenge posed by the disease. The pipeline is almost dry."
This comprehensive analysis illustrates the high rate of failure of compounds and the need for a constant supply of new drugs or a higher focus on repurposing, which can be assessed for efficacy in AD. With AD more expensive to the U.S. economy than cardiovascular disease or cancer, the Lou Ruvo Center for Brain Health research team believes the system of AD drugs must be supported, grown and coordinated to improve the success rate and development of new therapies.
In order to accelerate the drug development process and reduce the need to constantly invent new drugs, researchers note the need for more repositioning studies, which involve studying an already-approved drug in a new use or condition. For example, researchers at the Cleveland Clinic Lou Ruvo Center for Brain Health are leading a landmark Phase IIa clinical trial to determine if bexarotene (Targretin™), a drug currently FDA approved to treat skin cancer, can remove a protein build-up in the brains of Alzheimer's patients, as it did in a recent animal study.
For more information about clinical trials or the various programs available at Cleveland Clinic Lou Ruvo Center for Brain Health, visit ClevelandClinic.org/BrainHealthTrials or call 877-247-7800.
About Cleveland Clinic Lou Ruvo Center for Brain Health
Cleveland Clinic Lou Ruvo Center for Brain Health provides state-of-the-art care for cognitive disorders and for the family members of those who suffer from them. The physicians and staff at the Center for Brain Health continuously work towards the development of early diagnosis and the advancement of knowledge concerning mild cognitive disorders, which could one day delay or prevent their onset. Patients receive expert diagnosis and treatment at the Center for Brain Health, which offers a multidisciplinary patient-focused approach to diagnosis and treatment, promoting collaboration across all care providers, offering patients a complete continuum of care and infusing education and research into all that it does. The facility, designed by Frank Gehry, houses clinical space, a diagnostic center, neuroimaging rooms, physician offices, laboratories devoted to clinical research and the Keep Memory Alive Event Center. For more information, visit http://www.clevelandclinic.org/brainhealth.
About Cleveland Clinic
Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S.News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. More than 3,000 full-time salaried physicians and researchers and 11,000 nurses represent 120 medical specialties and subspecialties. The Cleveland Clinic health system includes a main campus near downtown Cleveland, eight community hospitals, more than 75 Northern Ohio outpatient locations, including 16 full-service Family Health Centers, Cleveland Clinic Florida, the Lou Ruvo Center for Brain Health in Las Vegas, Cleveland Clinic Canada, and, scheduled to begin seeing patients in 2015, Cleveland Clinic Abu Dhabi. In 2012, there were 5.1 million outpatient visits throughout the Cleveland Clinic health system and 157,000 hospital admissions. Patients came for treatment from every state and from more than 130 countries. Visit us at www.clevelandclinic.org. Follow us at www.twitter.com/ClevelandClinic.
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