Tuesday, January 14, 2014, Las Vegas: Researchers at Cleveland Clinic are participating in a new clinical trial designed to test the effectiveness of using a currently-approved diabetes drug to prevent the development of Alzheimer’s Disease in people who are predisposed to develop the condition. The study will also look at whether a new genetic biomarker, TOMM40, is an additional indication of a patient’s elevated risk of developing the disease.
The TOMMORROW trial, a Phase 3, five-year, double-blind, placebo-controlled study, is the nation’s largest prevention clinical trial for Alzheimer’s disease. The trial examines if the drug pioglitazone (AD-4833), currently FDA approved to treat type 2 diabetes, reduces inflammation and has a protective effect in the brain that can prevent high risk-patients from developing mild cognitive disorder and Alzheimer’s disease. The link between type 2 diabetes and Alzheimer's may occur as a result of the complex ways that type 2 diabetes affects the ability of the brain and other body tissues to use sugar (glucose) and respond to insulin.
“The TOMMORROW trial allows us to take a look at how we can combat Alzheimer’s disease before it even takes hold by studying cognitively normal individuals with no symptoms of memory impairment,” said Jeffrey Cummings, MD, Medical Director at Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. “Until now, the bulk of our research was focused on treating the disease, but with the advances in the science behind genetic biomarkers, we can now identify those who are predisposed to Alzheimer’s and start down the path of identifying drugs that may have the potential to prevent the disease all together.”
AD-4833 regulates glucose metabolism and insulin sensitivity, reduces inflammation and has a protective effect in the brain that could prevent high-risk individuals from developing Alzheimer’s disease. This study will evaluate AD-4833’s efficacy versus placebo in delaying the onset of Alzheimer’s in cognitively normal individuals, comparing the areas of cognitive decline, functional decline and daily living activities.
Researchers at Cleveland Clinic Florida in Weston, Fla. and the Lou Ruvo Center for Brain Health in Las Vegas, Nev. will screen thousands of people with the goal of enrolling about 120 participants per site. Those selected to participate will be randomized into either an active treatment or placebo group and will take the treatment drug orally once per day. Approximately 5,800 people will participate in TOMMORROW worldwide.
Participants must be cognitively normal, exhibiting no symptoms of memory impairment, and between 65-83 years old. All participants must undergo a genetic blood test, which will determine if the individual has a higher or lower possible genetic risk to develop Alzheimer’s disease. The genetic blood test is composed of APOE and TOMM40 genotypes and the individual’s age. Previous studies have shown age and APOE indicate an elevated risk of Alzheimer’s disease, and TOMM40 is hypothesized to further refine the risk determination.
High-risk participants will have a 50 percent chance to receive either AD-4833 or the placebo, and low risk participants will either receive the placebo, or in some cases, may not be eligible for the study. After randomization into the study, participants will be contacted every three months. Phone calls will be conducted at three and nine months, and site visits will be conducted at six and 12 months.
“The screening process to find the participants in the TOMMORROW study is extremely important. We’ll be identifying a unique group of individuals who have not yet been affected, but have a real possibility of a future with Alzheimer’s disease,” said Gabriel Léger, MD, principal investigator of TOMMORROW at Cleveland Clinic Lou Ruvo Center for Brain Health.
This trial is an example of a repositioning project, where researchers take an approved drug and study it in a new use or condition. Repositioning studies are designed to accelerate the drug development process and reduce the need to constantly invent new drugs when current treatments could be used in new ways.
The TOMMORROW study was initiated and funded by Takeda Pharmaceutical Company Limited (Takeda) and its partner, Zinfandel Pharmaceuticals Inc.
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. About 2,800 full-time salaried physicians and researchers and 11,000 nurses represent 120 medical specialties and subspecialties. Cleveland Clinic Health System includes a main campus near downtown Cleveland, eight community hospitals and 18 Family Health Centers in Northeast Ohio, Cleveland Clinic Florida, the Lou Ruvo Center for Brain Health in Las Vegas, Cleveland Clinic Canada, and, currently under construction, Cleveland Clinic Abu Dhabi. In 2010, there were 4 million visits throughout the Cleveland Clinic health system and 167,000 hospital admissions. Patients came for treatment from every state and from more than 100 countries. Visit us at www.clevelandclinic.org. Follow us at www.twitter.com/ClevelandClinic.
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 treatment of 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.
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