A phase I clinical trial to evaluate the safety and tolerability of a first-of-its-kind vaccine against
NEWPORT BEACH, Calif., March 2, 2023 /PRNewswire/ -- Hoag's Pickup Family Neurosciences Institute has started enrolling participants for a Phase 1 clinical trial evaluating the safety and tolerability of a first-of-its-kind Alzheimer's disease vaccine
Alzheimer's disease vaccine. The hope is that the vaccine will eventually be used to prevent
Alzheimer's disease in healthy people who are at risk.
Hoag is the only site in California among total six sites in the United States selected to participate in the study. This study is supported by a grant from the National Institute of Aging, a division of the National Institute of Health, to the study sponsor - the Institute of Molecular Medicine (Huntington Beach, CA) and its collaborators at the University of California, Irvine and the University of Southern California. This Phase 1 study is being conducted by Clinartis CRO, Miami, and includes eligible subjects aged 60 to 85 years with early symptoms of
Alzheimer's disease. The goal of the study is to evaluate the safety and tolerability of the vaccine, and also to assess the vaccine's impact on the levels of beta-amyloid in the brain, one of the associated biomarkers of
Alzheimer's disease, using positron emissions tomography (PET) scans
"Everything about this trial is groundbreaking," said Gus Alva, M.D., D.F.A.P.A, the principal investigator of the study at Hoag. "It's the first-in-human MultiTEP platform-based nucleic acid vaccine that, with successful trials, could be used to prevent the development of
Alzheimer's disease in cognitively health people but at risk of developing the disease, rather than waiting for the disease to manifest clinically and then slowing the progression.
The beta-amyloid vaccine induces a cellular immune response through a unique process that was proven in animal studies to reduce the misfolded amyloid plaques found in the brains of people contending with
"The goal is to develop an immunogenic vaccine to prevent this dreaded disease that now afflicts one in eight people over the age of 65," said Michael Brant-Zawadzki, M.D., Hoag's Senior Physician Executive, and the Ron and Sandi Simon Executive Medical Director Endowed Chair of the Pickup Family Neurosciences Institute. He credits Hoag's reputation within the field for its selection for this trial – as well as Hoag's longstanding memory and cognitive program caring for patients with this disease, and previous participation in a host of other innovative
Alzheimer's disease trials.
"The world-class talent we have here at Hoag attracts these very innovative projects," Dr. Brant-Zawadzki said. "We are able to offer our patients access to innovative care pathways, as well as access to these types of early-stage break-through trials. It's a tremendous honor and speaks to the caliber of research and expertise here at Hoag."
"After decades of effort, the medical field is able to offer Alzheimer's patients options. There is a whole menu of treatments becoming available, and now a possible prevention, that patients can choose from based on what might fit them best," Dr. Alva said. "We are very excited to be at the forefront of those opportunities, especially the vaccine. Most of the at-risk people in the U.S. don't get a crack at this vaccine, but the residents of Orange County do."
Hoag's Pickup Family Neurosciences Institute is currently offering many other Alzheimer's clinical trials. For more information or to enroll, call 949-764-6797 or email [email protected].
ABOUT HOAG'S PICKUP FAMILY NEUROSCIENCES INSTITUTE Delivering a personalized, integrated approach using best-practice guidelines, the most advanced technology, and integration of medical specialists in the most appropriate facilities, the Pickup Family Neurosciences Institute (PFNI) at Hoag provides world class care for patients with specific conditions of the brain and spine such as
memory and cognitive disorders,
pain, minimally invasive spine surgery,
multiple sclerosis, addiction medicine and sleep disorders, as well as the mind-body interface of behavioral health. Many of Hoag's PFNI programs have received high acclaim. The Hoag
Stroke Program was the first in Orange County and the second in California to be named a Certified Comprehensive
Stroke Center by DNV GL Healthcare and was awarded the American
Stroke Association's Get With The Guidelines
Stroke Gold Plus Performance Achievement for
stroke care. And as one of the first centers in the U.S. to offer the most advanced radiosurgical treatment system available, Leksell Gamma Knife® Perfexion™, the PFNI
brain tumor program is the largest in Orange County and is also among the top volume programs in the western United States. Hoag has been recognized as a designated Level 4 Comprehensive
Epilepsy Center by the National Association of
Epilepsy Centers. The PFNI's memory and
cognitive disorders program is nationally recognized.
Hoag is a nonprofit, regional health care delivery system in Orange County, California. Delivering world-class, comprehensive, personalized care, Hoag consists of 1,800 top physicians, 15 urgent care facilities, 10 health & wellness centers, and two award-winning hospitals. Hoag offers a comprehensive blend of health care services that includes six institutes providing specialized services in the following areas: cancer, digestive health, heart and vascular, neurosciences, women's health, and orthopedics through Hoag's affiliate, Hoag Orthopedic Institute, which consists of an orthopedic hospital and four ambulatory surgical centers. Hoag is the highest ranked hospital in Orange County by U.S. News & World Report and the only OC hospital ranked in the Top 10 in California, as well as a designated Magnet® hospital by the American Nurses Credentialing Center (ANCC). For more information, visit hoag.org. The Institute for Molecular Medicine (IMM) is a non-profit organization created with the goal of understanding, preventing, and curing chronic human diseases, including
neurodegenerative disorders. IMM works closely with its partner, Nuravax: a biotechnology company that licenses IMM's patented technology. Based in Orange County, California, IMM, along with Nuravax, is advancing MultiTEP: a universal vaccine platform technology that supports the development of multiple vaccine designs based on DNA, RNA, or recombinant proteins.
Research reported in this press release was supported by the National Institute on Aging (NIA) division of the U.S. National Institutes of Health (NIH) under grant number R01-AG074983. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.