MIAMI, Nov. 12 /PRNewswire/ -- The Miami Jewish Home and Hospital, Berma Research Group, and Segal Institute for Clinical Research today announced that they are actively enrolling patients in the CONNECTION study, a Phase 3 clinical trial that is evaluating the safety and efficacy of the investigational drug Dimebon as a treatment for mild-to-moderate Alzheimer's disease.
According to new estimates from the Alzheimer's Association, more than 5 million people in the United States are living with Alzheimer's disease, a progressive, debilitating and deadly disease that destroys brain cells and affects areas of the brain involved in memory, cognition, judgment, language and behavior. As the baby boomer population ages, the incidence of Alzheimer's disease is expected to increase dramatically. Currently available therapies for Alzheimer's treat the symptoms with modest effect, and there is no evidence that these medications alter the course of the underlying disease process.
"New therapies are urgently needed to more effectively treat the symptoms of Alzheimer's disease," said Dr. Marc Agronin, director of mental health services at the Miami Jewish Home and Hospital and associate professor of psychiatry at the University of Miami Miller School of Medicine. "Results from a previous study of Dimebon in Alzheimer's disease were encouraging, and we look forward to further assessing Dimebon's promise in the fight against Alzheimer's disease in the CONNECTION study. We encourage local patients and caregivers to learn more about this trial."
Dimebon is an investigational therapy in clinical development for the treatment of Alzheimer's disease. It targets Alzheimer's disease differently than currently available therapies. Mitochondria (a cell's primary source of energy) are the target of Dimebon's mechanism of action.
Medivation, Inc., the company developing Dimebon and sponsoring the CONNECTION study, previously announced efficacy and safety results from the first pivotal trial showing that Dimebon improved the clinical course of Alzheimer's disease. In that study, patients treated with Dimebon showed significant improvement over patients treated with placebo (sugar pill) in each of the five most important aspects of Alzheimer's: memory, thinking, behavior, activities of daily living (such as eating and hygiene) and overall function. These improvements were seen after as little as 12 weeks of treatment with Dimebon and were maintained over a full year of treatment. Dimebon was well tolerated throughout the one-year treatment period.
About the CONNECTION Study
The CONNECTION study will enroll 525 patients in the United States -- as well as sites in Europe and South America -- to test the effects of Dimebon in patients with mild-to-moderate Alzheimer's disease. The study will evaluate the impact of Dimebon on cognition (thinking and awareness), memory, daily functioning, behavior and the ability to care for oneself.
Patients age 50 and older who are not taking any other Alzheimer's prescription medications may be eligible for the six-month study. Patients will randomly be chosen to receive either Dimebon or placebo. After six months of treatment, all patients -- including those receiving placebo -- will be offered the opportunity to receive Dimebon in an extension trial.
For more information on eligibility and enrollment, patients and
caregivers can contact:
Miami Jewish Home & Hospital: 305-514-8503, http://www.mjhha.org
Berma Research Group: 305-702-9453, http://www.bermaresearch.com
Segal Institute for Clinical Research: 1-877-SEGAL-88,
CONNECTION study: 1-877-888-6386, http://www.connectionstudy.com
|SOURCE Miami Jewish Home & Hospital; Berma Research Group; SegalInstitute|
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