Cleveland Clinic's fourth annual analysis of Alzheimer's disease drug development found that the pipeline has grown in the number and variety of agents being tested over the past year, while highlighting several advances in the field including new clinical trial designs, more detailed criteria for making a research diagnosis, and an increased use of biological tests reflecting of the disease.
Based on the federal website ClinicalTrials.gov, the paper, Alzheimer's disease drug development: pipeline 2019, is Cleveland Clinic's fourth review of Alzheimer's disease drug development and appears as a July featured article in Alzheimer's & Dementia: Translational Research & Clinical Trials Interventions (TRCI), an open access journal of the Alzheimer's Association.
"Improvements to clinical trial design and new guidelines for a research diagnosis of Alzheimer's disease have allowed for accuracy in studies and precision in the staging of Alzheimer's disease, which are increasingly important in drug development," said Jeffrey Cummings, M.D., ScD, director emeritus of Cleveland Clinic Lou Ruvo Center for Brain Health, director of the Center for Neurodegeneration and Translational Neuroscience and research professor at the University of Nevada, Las Vegas department of Brain Health. "This progress is a result of key collaborations amongst stakeholders and has elevated us to an unprecedented stage of drug development. We've never seen more funding, more agents or more diversity in the pipeline."
At a time when scientists are now reexamining the role of therapies targeting amyloid, this year's pipeline shows a trend toward a more diverse approach in attacking Alzheimer's disease. These agents include, anti-tau, neuroprotective, anti-inflammatory, regenerative (stem cells) and metabolic interventions. Additional trends include a variety of approaches to deep brain stimulation as well as ribonucleic acid (RNA)-based therapies.
"It's been really disappointing to see these last couple of clinical trials fail. We were worried that this would have a devastating impact on Alzheimer's drug development, but when we surveyed the landscape, we were encouraged to see more, not fewer agents being developed," said Aaron Ritter, M.D., director of clinical trials at Cleveland Clinic Lou Ruvo Center for Brain Health. "Every drug failure is an opportunity for learning, and it is our hope that through this paper, the public will see the importance of clinical trial participation. The bottom line is that as the pipeline grows, so does the number of people needed to test these medications."
Drs. Cummings and Ritter, along with fellow authors Garam Lee, Pharma.D., a clinical research pharmacist at Cleveland Clinic Lou Ruvo Center for Brain Health; Marwan Sabbagh, M.D., director of Cleveland Clinic Lou Ruvo Center for Brain Health; and Kate Zhong, M.D., CEO of CNS Innovations examined all clinical trials from 2018 to 2019 to uncover the diversity in the pipeline as well as innovations utilized in current trials such as designs, outcomes, populations and biomarkers.
The authors note that several new clinical trial designs - including futility analyses and adaptive trial designs, as seen in the development of cancer and diabetes medications - increase the speed and sophistication of conducting Alzheimer's disease clinical trials. Another important trend in the field is a move toward testing medications in people either minimally effected or even before the onset of symptoms.
Several Alzheimer's prevention studies enrolling people based on their genetic predisposition to Alzheimer's disease are now being conducted. Moving forward, the authors' specific areas of interest include repurposed agents, immunotherapies, and novel mechanisms of action (MOA).
For additional information about Cleveland Clinic Lou Ruvo Center for Brain Health, visit ClevelandClinic.org/Nevada. For additional information about Cleveland Clinic Center for Neurological Restoration, visit Newsroom.ClevelandClinic.org.
About Cleveland Clinic Lou Ruvo Center for Brain Health:
Cleveland Clinic Lou Ruvo Center for Brain Health provides expert diagnosis and treatment for individuals and families living with Alzheimer's, Parkinson's and Huntington's diseases; multiple sclerosis; frontotemporal dementia and related disorders; and multiple system atrophy. The center offers a continuum of care with no-cost opportunities for the community to participate in education and research, including disease prevention studies and clinical trials of promising new medications. An integrated entity, Keep Memory Alive, raises funds exclusively in support of the Lou Ruvo Center for Brain Health in Las Vegas, Nevada. For more information, visit http://www.clevelandclinic.org/brainhealth and http://www.keepmemoryalive.org.
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. Among Cleveland Clinic's 66,000 employees are more than 4,200 salaried physicians and researchers and 16,600 nurses, representing 140 medical specialties and subspecialties. Cleveland Clinic's health system includes a 165-acre main campus near downtown Cleveland, 11 regional hospitals in northeast Ohio, more than 180 northern Ohio outpatient locations - including 18 full-service family health centers and three health and wellness centers - and locations in southeast Florida; Las Vegas, Nev.; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2018, there were 7.9 million total outpatient visits, 238,000 hospital admissions and observations, and 220,000 surgical cases throughout Cleveland Clinic's health system. Patients came for treatment from every state and 185 countries. Visit us at clevelandclinic.org. Follow us at twitter.com/CCforMedia and twitter.com/ClevelandClinic. News and resources available at newsroom.clevelandclinic.org.
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