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| |  DG DISPATCH - AAGP: Donepezil Preserves Functional Status In Alzheimer's Patients By Lisette Hilton Special To DG News MIAMI BEACH, FL. -- March 15, 2000 -- A goal for physicians who treat patients with Alzheimer's disease has always been to help patients stave off the disease's inevitable deterioration of function. A study presented at the 13th Annual Meeting of the American Association for Geriatric Psychiatry (AAGP) has concluded that one way of achieving that goal is with donepezil, a piperidine-based acetylcholinesterase inhibitor. The AAGP meeting is being held in Miami Beach, FL, March 12-15, 2000. While donepezil has been studied in the past, this study, entitled "Donepezil Preserves Functional Status in Alzheimer's Disease Patients: Results from a One-year Prospective Placebo-controlled Study," looked at more than patients' loss of ability to perform activities of daily living (ADLs), such as bathing and dressing. It also studied instrumental activities of daily living (IADLs), such as shopping and food preparation. To do this, the researchers used a new scale specifically formulated for Alzheimer's disease -- the Alzheimer's Disease Functional Assessment and Change Scale (ADFACS)-- a 16-item functional assessment scale, which is intended to eliminate gender bias. It includes instrumental items reflecting the functional impairment of mild to moderate Alzheimer's disease. "This is the first US study of acetylcholinesterase inhibitors to evaluate the effects of one year's therapy in patients with Alzheimer's disease," said Richard Mohs, PhD, professor in the department of psychiatry, Mount Sinai School of Medicine, and the study's lead investigator. In a press statement, Dr. Mohs also said that the findings of this study suggest that prolonged treatment with donepezil is an important weapon to help patients improve or maintain their independence while living with the disease. Researchers found that while Alzheimer's continued to progress over time, donepezil significantly delayed functional loss. In fact, patients taking donepezil maintain their functional ability for about five months longer (median time) than those on placebo. The researchers also concluded that donepezil is generally well tolerated. The study was conducted with patients who had possible or probable Alzheimer's disease. It was a multi-center study, employing once daily doses of either placebo or a 10 mg/daily dose of donepezil. Patients randomized to donepezil received 5 mg for 28 days before going on the 10-mg/daily dosage, according to Raymond D. Pratt, MD, an author of the study and senior director of clinical research and development, at Eisai, Inc., a global health care company in Teaneck, NJ. The researchers had defined criteria for clinically evident declining function and kept to those criteria, Dr. Pratt explained. Patients were excluded from the study if they were determined from the criteria to have experienced declining function. The study involved 431 patients -- 217 received placebo and 214 received donepezil. The study population was approximately 65 percent female, which is typical for an Alzheimer's population study in the US. The number of patients who completed the study and showed no criteria for functional decline was about 20 percent of the placebo group and about 31.3 percent in the donepezil group. The study shows that about 56 percent of the placebo group compared with 41 percent of the donepezil group had criteria for clinically evident functional decline and were removed from the study. Donepezil treatment significantly extended the median time of functional decline. The median time for functional decline was 208 days in the placebo group and 357 days in the donepezil group. Furthermore, there was no evident decline in 51 percent of patients treated with donepezil after 48 weeks of treatment, compared with only 35 percent of placebo patients. The risk of clinically evident functional decline of the patients receiving donepezil was practically 62 percent of that of the placebo group. Even among the patients who did not reach the criteria for clinically evident functional decline and continued on their medication, the placebo group had greater functional impairment and lower cognitive test scores than the donepezil group, according to the results. The most likely adverse events experienced by the donepezil group were nausea, vomiting, anorexia, headache and urinary tract infections. The drug was generally well tolerated, the researchers said. They found no significant differences between the placebo and donepezil groups that were treatment related. "This study particularly brings out the new scale, the ADFACS, that was developed specifically for this study and overcomes a number of the problems with previous ADL scales that have been used in clinical trials. Specifically, it adds new items into the ADL scale -- particularly instrumental activities that eliminate gender bias and are specific for patients with mild to moderate Alzheimer's disease and are clinically evident within the population that we're studying," Dr. Pratt explained. Related Link: Donepezil (Aricept).
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