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.'
About Dimebon
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,
http://www.segaltrials.com
CONNECTION study: 1-877-888-6386, http://www.connectionstudy.com
SOURCE Miami Jewish Home & Hospital; Berma Research Group; Segal Institute
for Clinical Research
