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Reminyl (Galantamine) May Reduce Specific Behavioral Symptoms in Patients With Alzheimer's Disease

Patient Improvement May Reduce Caregiver Distress

TITUSVILLE, NJ -- April 19, 2004 -- New data published in the March issue of the American Journal of Psychiatry is the first to suggest that treatment with ReminylŪ (galantamine hydrobromide) may reduce specific behavioral symptoms in patients with mild to moderate Alzheimer's disease, which may contribute to a reduction in caregiver distress.

The study had three key findings: patients who exhibited behavioral disturbances at the start of the study experienced robust reductions in symptoms; patients who did not have behavioral disturbances showed less emergence of symptoms; and, the reduction in behavioral-related caregiver distress was statistically significant.

The findings from the 21-week study reported that patients treated with 16 or 24 mg/day of Reminyl who exhibited behavioral disturbances when they entered the study experienced meaningful reductions (29 percent to 48 percent) in aberrant motor behavior, agitation and anxiety versus placebo. Additionally, patients treated with up to 24 mg/day, who were without behavioral symptoms at baseline, revealed significantly less emergence of aberrant motor behavior, apathy and disinhibition than patients on placebo.

"The study tracked caregiver distress as it related to the patient's behavior. The reduction in behavior-related caregiver distress was modest but significant in the caregivers of patients receiving Reminyl 24 mg/day compared with those on placebo," said Jeffrey Cummings, M.D., director, University of California at Los Angeles (UCLA) Alzheimer's Center, the lead author on the study. "Reducing caregiver distress is important because of the integral role caregivers play in the overall management of patients with Alzheimer's disease."

The research focused on monitoring changes in patients' behavioral symptoms as measured by the Neuropsychiatric Inventory, which measures 10 areas of behavior commonly found in patients with Alzheimer's disease. These include delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability and aberrant motor behavior. After 21 weeks, the total score on the Neuropsychiatric Inventory was reduced by 0.1 point in the 16- and 24-mg/day REMINYL groups and increased by 2.3 points in the placebo group. Decreased scores indicate improvement on this scale.

"This analysis suggests that REMINYL addresses behavioral symptoms of Alzheimer's in addition to helping to preserve function and cognition," said Dr. Cummings. "In addition, there has been no study of other acetylcholinesterase inhibitors that has shown a reduction of new behavioral disturbances in patients who did not have these symptoms at the beginning of the study."

The study analyzed data from 978 patients with mild to moderate Alzheimer's disease who were randomly assigned to placebo or Reminyl, 80 percent of whom completed the trial. Patients were titrated according to the approved product labeling to maintenance doses of 16 or 24 mg/day.

Like other Alzheimer's disease treatments that are acetylcholinesterase inhibitors, Reminyl enhances levels of the neurotransmitter acetylcholine (a chemical "messenger" responsible for sending signals between nerve cells in the brain), which is thought to play a key role in memory and learning, and is typically deficient in Alzheimer's disease. However, data suggest that Reminyl also has a modulating effect on the brain's nicotinic receptors. While the clinical significance of this mechanism is unknown, nicotinic receptors are thought to play a key role in attention, memory and learning.


SOURCE: Janssen Pharmaceutica Products, L.P.

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