Tuesday March 16, 8:00 am Eastern Time
Company Press Release
SOURCE: Novartis Pharmaceuticals Corporation
First Worldwide Study Aims at Delaying Onset of Alzheimer's Disease In High-Risk Group
Experts Cite Mild Cognitive Impairment as Potential Early Indicator of Probable Alzheimer's Disease - Call 877-554-HOPE For More Information
EAST HANOVER, N.J., March 16 /PRNewswire/ -- Novartis Pharmaceuticals Corporation issued the following:
WHAT:
Experts at the American Association for Geriatric Psychiatry (AAGP) annual meeting will discuss a new clinical trial to evaluate the efficacy of an investigational new drug, Exelon®(rivastigmine) in prolonging the time between development of mild cognitive impairment and a subsequent diagnosis of probable Alzheimer's disease.
This clinical trial, called the InDDEx Study (Investigation into Delay to Diagnosis of Alzheimer's Disease with Exelon®) will take place in approximately 50 centers around the world. It will be the only global trial examining the link between early intervention and delay to diagnosis of Alzheimer's disease.
WHEN:
Telephone Briefing: Tuesday, March 16
12:00 - 12:45 EST (9:00 - 9:45 PST)
Dial: 800-945-1600
Code: Annual Meeting Press Conference
WHY:
People with mild cognitive impairment (MCI) suffer from mild memory loss that is often mistaken as part of the natural aging process. However, studies show that up to 44 percent of people with MCI will develop Alzheimer's disease within three years of diagnosis. Alzheimer's disease is currently the fourth leading cause of death in the United States, affecting 3 to 4 million American adults and 10 million worldwide.
WHO:
George T. Grossberg, M.D.
Samuel W. Fordyce Professor & Chairman
Director, Division of Geriatric Psychiatry
Department of Psychiatry & Human Behavior
Health Sciences Center
School of Medicine
St. Louis University
P. Murali Doraiswamy, M.D.
Director, Clinical Trials
Department of Psychiatry & Behavioral Sciences
Duke University Medical Center
CONTACT:
Lindy Moran of Moran Communications, 212-966-4187, for Novartis.
EAST HANOVER, N.J., March 16 -- Novartis Pharmaceuticals Corporation announced today that it is sponsoring a new clinical trial to evaluate the efficacy of an investigational drug, Exelon® (rivastigmine), for a new indication to prolong the time between development of mild cognitive impairment and a subsequent diagnosis of probable Alzheimer's disease. Exelon is currently under review with the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate Alzheimer's disease.
People with mild cognitive impairment (MCI) suffer from a mild memory loss that is often initially mistaken for part of the natural aging process. However, studies show that up to 44 percent of people with MCI will develop Alzheimer's disease within three years of diagnosis. Some scientists believe that early detection and treatment of MCI may delay the progression to Alzheimer's disease.
''Increasingly, mild cognitive impairment appears to be a transitional stage on the continuum from forgetfulness to Alzheimer's among the aging population,'' said Steven Ferris, Ph.D., Professor of Psychiatry at NYU School of Medicine and Principal Investigator of the study. Alzheimer's -- a progressive disease involving deterioration of the brain -- affects 3 to 4 million adults in the United States and 10 million worldwide. A delay in its onset would be a significant advance in helping to defer suffering among a large number of patients and caregivers.''
Symptoms of mild cognitive impairment include a variety of subtle changes in personality, including social withdrawal, a reluctance to participate in once-cherished routines or hobbies, repetitive conversations or paranoid behavior. Most people with MCI continue to work or run households but, increasingly, cannot remember recent events or the names of common items. Symptoms may also be apparent only selectively -- while a person may be able to drive without getting lost, he may not always be able to recall information spoken to him or successfully identify two shoes as a pair.
''In just a few years, when the Baby Boom generation reaches the age of highest risk for Alzheimer's disease, the number of people afflicted could double,'' said William Thies, Ph.D., the Alzheimer's Association's vice president for medical and scientific affairs. ''That's why we support large-scale research trials that test possible methods to prevent the disease by delaying its onset. We must prevent Alzheimer's disease -- both to save individuals and families from suffering from it and to save our economy from collapsing under its burden.''
Alzheimer's disease is the fourth leading cause of death behind cardiovascular disease, cancer and stroke. With an annual US price tag of approximately $100 billion in direct (healthcare and related) and indirect (income) costs, it is estimated that delaying the onset of the disease by five years could save the nation's healthcare system as much as $50 billion.
The InDDEx Study (Investigation into Delay to Diagnosis of Alzheimer's Disease with Exelon®)
Approximately 50 centers around the world are participating in this study, known as Investigation into Delay to Diagnosis of Alzheimer's Disease with Exelon (InDDEx). This Phase IIIb (U.S.)/IV (international), 900-patient, double-blind, placebo-controlled, 36-month worldwide trial is the only global trial examining the link between early intervention and delay to diagnosis of Alzheimer's disease. It will compare the impact of Exelon with that of placebo in delaying the progression from MCI to probable Alzheimer's disease.
''The InDDEx study is the first global MCI study to use magnetic resonance imaging to map changes in brain atrophy, or deterioration,'' said Ravi Anand, M.D., Director of Medical Affairs at Novartis Pharmaceuticals Corporation. ''This will provide us with important new insights into how mild cognitive impairment may progress to Alzheimer's disease and help us explore effective intervention methods to help people maintain their quality of life for a longer period of time.''
To date, Exelon® has been cleared for marketing in more than 40 countries for the treatment of mild to moderate Alzheimer's disease, including all 15 member states of the European Union, New Zealand, Argentina, Brazil and Mexico. Exelon is currently under review with the U.S. Food and Drug Administration.
In addition to evaluating the ability of Exelon to delay a diagnosis of Alzheimer's disease, the following evaluations will also be conducted: cognitive functions, activities of daily living (ADLs), behavior, quality of life and use of healthcare resources.
To be eligible for the program, participants must be:
-- Diagnosed with MCI
-- Aged 55 - 85 years
-- Male, or female without child-bearing potential
-- Able to ingest oral medication
-- Willing to complete all aspects of the study
In addition, each participant must have a family member or friend who will commit to see them at least once a week and be available for periodic visits to the center and occasional telephone consultations.
Participants and their family members or caregivers can learn more about InDDEx including the locations of trial sites by calling toll-free 877-554-HOPE. For more information about Alzheimer's disease research, and programs for caregivers and people with the disease, call the Alzheimer's Association at 800-272-3900.
Clinical studies have shown that Exelon has a favorable safety profile and is well-tolerated. Side effects observed in the clinical trials were generally consistent with those seen in other acetylcholinesterase inhibitors. The most common side effects include nausea, vomiting, anorexia, dyspepsia and asthenia, which are generally mild and occur most frequently during the titration period, usually resolving during continued Exelon treatment. Exelon demonstrated a good safety profile with no hepatic, cardiovascular, renal or pulmonary effect.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of the Novartis Group, a world leader in Life Sciences with core businesses in Healthcare, Agribusiness and Consumer Health (Nutrition and Self-Medication). In 1998, Novartis Group sales were USD 21.8 billion, of which USD 12.0 billion were in Healthcare, USD 5.8 billion in Agribusiness and USD 4.0 billion in Consumer Health. The group annually invests more than USD 2.5 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 85,000 people and operates in over 100 countries around the world.
SOURCE: Novartis Pharmaceuticals Corporation
|
