To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Reminyl (Galantamine) May Help Patients With Alzheimer's Disease to Maintain Activities of Daily Living URL: http://www.pslgroup.com/dg/244C9E.htm Doctor's Guide August 23, 2004
Greatest Differences Found in Patients With More Advanced Disease TITUSVILLE, NJ -- August 23, 2004 -- Data published in the July issue of the Journal of the American Geriatrics Society suggest that treatment with Reminyl® (galantamine hydrobromide) may help to maintain the ability of patients with mild to moderate Alzheimer's disease to perform certain activities of daily living (ADLs), such as grooming, walking and being aware of current events. The findings from the double blind, placebo-controlled, multicenter, five- month study showed that patients receiving placebo demonstrated greater deterioration in their ability to perform ADLs than patients treated with Reminyl. Patients at more advanced stages of the disease when the study began benefited most. "Clinical trials most often focus on cognitive testing to assess the progression of the disease," explained Douglas Galasko, M.D., professor, Department of Neurosciences, University of California at San Diego. "However, loss of functional abilities is associated with increased caregiver burden, and once lost, these abilities rarely are recovered. Maintaining a patient's ability to carry out daily activities has the potential to benefit both patients and caregivers." This trial demonstrated that treatment with Reminyl may make a significant difference in helping patients maintain activities of daily living. "This indicates that a goal of Alzheimer's disease treatment should be to preserve the patient's activities of daily living for as long as possible. However, we also need to evaluate the effects of Reminyl on ADLs in studies that are longer than five months," said Dr. Galasko. The Alzheimer's Disease Cooperative Study ADL Inventory (ADCS/ADL) was the primary outcome measure in this post hoc analysis of the original trial, which was published in 2000.(i) It includes questions on six basic activities, such as bathing and dressing and 17 more complex activities such as shopping and reading. For each ADL, the scores range from 0, reflecting nonperformance or the need for extensive help, to a higher score, representing independent performance, with a total score of 78 points. Patients treated with Reminyl had significantly higher overall ADL scores than the placebo group at five months. Patients on placebo dropped an average of 4.0 points from baseline, while patients taking 16 or 24 mg of Reminyl decreased 0.5 points and 1.6 points, respectively. When data from patients were categorized based on dementia at baseline, the largest treatment-versus- placebo differences occurred in patients with more advanced dementia at baseline. The study authors speculated that this difference may relate to more rapid ADL decline in patients with more advanced dementia. The study analyzed data from 659 patients with mild to moderate Alzheimer's disease who were randomly assigned to placebo or Reminyl, 79 percent of whom completed the trial. Patients had a history of cognitive decline that was gradual and progressive for at least six months. Patients were titrated according to the approved product labeling to maintenance doses of Reminyl, 16 or 24 mg/day. The study was supported by Janssen Medical Affairs, LLC. Reminyl is indicated for treatment of mild to moderate Alzheimer's disease. The most frequent adverse events are nausea, vomiting, diarrhea, anorexia and weight loss. They are usually mild and temporary. For more information, refer to the full prescribing information for Reminyl or visit http://www.reminyl.com. 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. Janssen Pharmaceutica Products, L.P., the company that manufactures and markets Reminyl, provides a free support program for both caregivers and health care professionals called SharingCare. For more information, visit http://www.SharingCare.com. Reminyl was developed by Johnson & Johnson Pharmaceutical Research & Development under a co-development and licensing agreement with UK-based Shire Pharmaceuticals Group plc. The product is approved for the treatment of mild to moderate Alzheimer's disease in 66 countries. References: (i) Tariot, PN, Solomon PR, Morris JC et al. A 5-month, randomized, placebo-controlled trial of galantamine in AD. Neurology 2000; 54:2269-2276. SOURCE: Janssen Pharmaceutica Inc. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. 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