New Research shows Aricept® (donepezil hydrochloride) maintained or improved cognition and global function in Alzheimer’s disease patients who resided in nursing homes. This is according to study results published in the December 2001 issue of the Journal of the American Geriatrics Society.
The efficacy of Aricept® in nursing home patients was similar to previously reported results in studies of outpatients with mild to moderate Alzheimer’s disease. The findings suggest that advanced age, co-morbid illnesses, and high concomitant medication usage should not be barriers to treatment with the medication. However the study authors suggest that appropriate precautions should be taken when treating such patients with Aricept®.
“These findings offer patients, their families and the medical community evidence that Alzheimer’s disease can be effectively treated and managed in the nursing home setting,” said Pierre N. Tariot, MD, study investigator and professor of psychiatry, University of Rochester (New York) School of Medicine. “In demonstrating that age or residence in a nursing home are not barriers to treatment for Alzheimer’s disease, this study emphasizes the need to raise awareness among nursing home staff of the disease and its symptoms.”
The multicenter, double-blind placebo-controlled study examined 208 nursing home patients with an average age of 85, and possible or probable Alzheimer’s disease to determine the efficacy, safety, and tolerability of Aricept treatment. The average MMSE(I) score of 14.4 for patients in the study indicated dementia in the moderate range at baseline.
Consistent with previous studies, Aricept® was generally well tolerated in this population despite advanced patient age and high use of other medications.
“It is important not to dismiss memory problems as just ‘normal aging’,” continued Tariot. “Recognizing symptoms of dementia and getting an early diagnosis give patients a greater chance of benefiting from medical interventions, including treatment with medications such as Aricept®.”
During the 6-month trial, the 208 patients were evaluated on the NPI-NH(II) and MMSE every 4 weeks, and every 12 weeks on the Clinical Dementia Rating-Sum of the Boxes (CDR-SB), which was adapted for use in the nursing home setting. The CDR-SB is scored based on interviews with both the caregiver and the patient, and provides an overall or global measure of dementia severity, based on items to assess both cognition and patient function. These items include memory, orientation, judgment and problem solving, community affairs, home life in room and hobbies and personal care.
Patients in the active group received 5 mg of Aricept® once daily for the first 4 weeks and 10 mg once daily for the remaining 20 weeks. Average NPI-NH total scores improved in both groups relative to baseline at all assessments with no statistically significant differences.
Differences in mean change from baseline scores for the MMSE favored Aricept® treated patients over placebo at all time points, and were statistically significant at weeks 8, 16 and 20. Differences in average change from baseline on the CDR-SB favored Aricept® at both weeks 12 and 24. At week 24, Aricept®-treated patients tended to improve on both cognitive and functional items of the CDR-SB compared with those receiving placebo.
Weight loss, abdominal pain, nausea, tremor and muscle weakness were reported more frequently in Aricept® treated patients. The occurrence of bradycardia (slow heartbeat) was similar for the two treatment groups. Adverse events were generally mild in intensity, transient, and similar to those reported previously in outpatient studies.