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| |  Reminyl (Galantamine) Offers Hope In Alzheimer's Disease TITUSVILLE, NJ -- June 26, 2000 -- Galantamine hydrobromide (Reminyl), an investigational treatment for Alzheimer's disease, may not only improve patients' memory, it also may delay loss of functioning and the emergence of behavioral symptoms, according to a study published in the June 27 issue of Neurology, the journal of the American Academy of Neurology. This is the first double-blind study to show positive results for an Alzheimer's treatment in all three types of disability commonly associated with the disorder. Results of the five-month clinical trial also suggest that treatment with galantamine is generally well tolerated, despite the fact that many of the elderly participants had other health conditions and were taking other medications. Galantamine is being developed by Janssen Pharmaceutica under an agreement with UK-based Shire Pharmaceuticals Group, plc. A new drug application for galantamine was filed by Janssen in September 1999 and currently is under review by the U.S. Food and Drug Administration (FDA). "There are at least two victims in this illness: the patient and the caregiver," says lead author Pierre Tariot, MD, professor of psychiatry, medicine and neurology at the University of Rochester Medical Center in New York. "Improving the patient's ability to remember, and to think clearly and rationally, is still a major treatment goal. But just as important is a patient's ability to perform simple tasks such as bathing, dressing and eating, and to interact with others. Anything that improves or helps stabilize this ability to function helps ease the burden on caregivers. We need more treatment options to help patients and caregivers achieve these goals, and this study suggests that galantamine offers potential benefits." In the multi-center, double-blind, placebo-controlled study, 978 patients with mild to moderate Alzheimer's disease were randomized to four different treatment arms: One group (n=286) received placebo for five months; the other three received a maximum daily galantamine dose of 8 mg (n=140), 16 mg. (n=279) or 24 mg. (n=273) for the same period of time. The groups that received 16 and 24 mg of galantamine were titrated up to their maximum doses over a course of up to eight weeks. Efficacy primarily was assessed using the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog) -- which measures a patient's memory, language and orientation -- and the Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus), which provides an overall assessment of patient functioning, including behavior, psychiatric symptoms, cognition and activities of daily living. Other efficacy measures were conducted at several intervals during the study and included the Alzheimer's Disease Cooperative Study Inventory that assesses activities of daily living (ADCS/ADL), such as the ability to use household appliances and practice good personal hygiene. In addition, patients were assessed using the Neuropsychiatric Inventory (NPI), which evaluates the frequency and severity of 10 types of behavioral symptoms, including delusions, hallucinations, aggression, anxiety and apathy. Overall, the patient groups treated with the 16- and 24-mg daily doses of galantamine scored higher on each efficacy measure than study participants who received placebo. On average, the ADAS-cog scores for these two groups of patients were significantly better after five months of treatment than they were at the start of the study, whereas the patients in the placebo group deteriorated (p<0.001). In addition, using the CIBC-plus scale, physicians judged patients' overall ability to function as improved or remaining stable in 64 and 68 percent of patients who took 16 or 24 mg of galantamine respectively, compared to 47 percent of those who received placebo (p<0.001). Likewise, patients who received these doses of galantamine fared better as a group than those who took placebo in terms of both the frequency and severity of behavioral symptoms and their ability to perform activities of daily living (ADLs). Among those who took 16 or 24 mg. per day of galantamine, the ADL scores showed a significantly smaller decrease over five months than the participants who got placebo (p<0.01). In addition, after five months of treatment, patients who took these doses of galantamine stayed virtually stable in their behavioral (NPI) scores, whereas those who received placebo deteriorated (p<0.01). Adverse side effects experienced by study participants were mostly gastrointestinal in nature, and were reported as mild and temporary. The discontinuation rate due to adverse effects was similar between the groups taking the proposed galantamine maintenance dose of 16 mg per day and those receiving placebo (7 percent for both groups). The proportion of patients reporting any serious adverse effects was similar for both patients taking 16 mg. of galantamine and those receiving placebo (10 percent vs. 11 percent respectively). Side effects that were reported at least 5 percent more often by patients taking galantamine as by those receiving placebo included nausea and diarrhea (13 percent vs. 5 percent and 12 percent vs. 6 percent, respectively). A similar safety profile was observed in the group taking 24 mg. of galantamine daily. Similar to other therapies currently on the market, galantamine inhibits an enzyme called acetylcholinesterase that breaks down acetylcholine -- a critical neurotransmitter that plays a key role in memory and learning. Decreased levels of acetylcholine long have been considered a significant contributor to the symptoms of Alzheimer's disease. Laboratory research suggests that galantamine also indirectly acts on the brain's nicotinic receptors, to which acetylcholine binds. This research further suggests that galantamine increases these receptors' sensitivity to acetylcholine, and in turn stimulates its release. The clinical significance of this finding is not yet known, but is being investigated further by Janssen. Related Links: Galantamine hydrobromide (Reminyl) and Janssen Pharmaceutica.
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