PROVIDENCE, R.I., Aug. 23 /PRNewswire/ -- Results of a new study published in this month’s issue of “Neurology” show that ARICEPT(R) (donepezil HCI), commonly used in the treatment of mild to moderate Alzheimer’s disease, may also offer hope to those suffering from Mild Cognitive Impairment (MCI). This is the first published paper of a placebo-controlled trial with this class of drug to improve cognitive symptoms in MCI.
MCI impacts more than 5 million Americans and the numbers are growing rapidly with the aging population. Patients in this study had the amnestic form of MCI. Patients with amnestic MCI have memory impairment out of proportion for their age but they do not meet the accepted criteria for Alzheimer’s disease or other types of dementia. These patients are likely in a transitional state from age-related memory loss and Alzheimer’s disease. Patients with MCI convert to Alzheimer’s disease at the rate of 10 to 15 percent per year compared to one to three percent in the overall, elderly population.
The study tracked 270 patients who were treated in a 24-week, multi- center, randomized, double-blind and placebo-controlled study. Compared with those in the placebo group, “patients reported feeling sharper mentally, more organized and more confident of their memory,” says lead author on the article, Stephen Salloway, M.D., Director of Neurology and The Memory and Aging Program at Butler Hospital and Professor of Clinical Neuroscience’s and Psychiatry at Brown Medical School in Providence, Rhode Island. The study was supported by Eisai Inc. and Pfizer Inc.
This project helps set the stage for future research. “Currently there is no established methodology for studying mild cognitive impairment,” explains Salloway. “We learned a lot about which tests are most sensitive for detecting cognitive changes in MCI patients.” For example, MCI patients on donepezil improved significantly over placebo on a test called the ADAS-Cog which has been used as a primary outcome measure in clinical trials for Alzheimer’s disease. This finding should help guide the design of future MCI trials.
People with MCI have the most trouble remembering recently acquired information and knowledge, while their recall of long ago events may remain intact. For example, they may vividly remember something they did as a child, but their recall of what happened yesterday may be fuzzy or missing. Yet despite these changes, these patients typically are capable of managing the activities of daily living.
There are currently no FDA approved treatments for MCI. The cognitive improvements seen on the secondary outcome measures in this study are encouraging and build on the recent report by Petersen and colleagues at the IXth International Conference on Alzheimer’s Disease in Philadelphia of the 3 year NIH-sponsored study showing that donepezil slowed conversion from amnestic MCI to dementia over the first 18 months of the trial. More definitive trials of cholinesterase inhibitors for treatment of MCI are needed.
Founded in 1844, Butler Hospital was the first hospital in Rhode Island and one of the first psychiatric facilities in the country. Butler’s inpatient and partial hospital specialty programs provide comprehensive assessment and treatment of psychiatric and substance abuse disorders affecting children, adolescents, and adults. A member of the Care New England System and affiliated with Brown Medical School, Butler is actively engaged in a variety of major research studies. It was named one of the 30 “best” psychiatric facilities in the United States in 2003 and 2004 by U.S. News & World Report. Its web site is http://www.butler.org/.
Note To Editors: MCI Study Details
In this 24-week, multicenter, randomized, double-blind, placebo- controlled, parallel-group study, patients were randomized to receive placebo (n=137) or donepezil (n=132, 5 mg/d for first 42 days and 10 mg/d thereafter). Patients were evaluated either as an intent-to-treat (ITT) population or a fully evaluable (FE) population consisting of patients who had a study medication compliance rate of at least 80 percent at the end of the study.
Both treatment groups had improved Clinician’s Global Impression of Change-MCI (CGIC-MCI) scores at endpoint, with no significant difference between ARICEPT(R) and placebo. Significant differences favoring ARICEPT(R) were measured by the modified ADAS-cog total score (P<.001). In addition, the FE population benefited significantly from ARICEPT(R) treatment, according to the following test scores:
* The ARICEPT(R) group performed significantly better on the ADAS-cog Immediate Word Recall test (p=.034), and there was a tendency toward significance on the Delayed Recall test (p=.053) compared to placebo. * The NYU Paragraph Intermediate and Delayed Recall test and the Digit Span Backwards test were significantly in favor of the ARICEPT(R) treatment group compared to placebo (p<.05). * Significant differences in favor of ARICEPT(R) were observed in the Patient Global Assessment scores (p=.007) compared to placebo. * Adverse events were reported by 88 percent of the ARICEPT(R) group and 73 percent of the placebo group, most of which were mild or moderate in severity. Diarrhea, nausea, vomiting, abnormal dreams, insomnia and leg cramps occurred in greater than five percent and twice the rate of placebo.
Butler Hospital
CONTACT: Mary Ingram Schatz, +1-773-955-2126, mary@ingramschatz.com, orJames Hallan, +1-401-455-6264, jhallan@butler.org both for Butler Hospital
Web site: http://www.butler.org/
