Long-term donepezil may hold other benefits: cognition of Alzheimer's patients may appear unchanged, but behavioral benefits may result.
In a study of 202 patients, those who continued treatment with the acetylcholinesterase inhibitor donepezil had significant improvements in their scores on the Neuropsychiatric Inventory, even when their scores on the Mini-Mental State Examination (MMSE) were stagnant or had declined.
"The implication is that physicians cannot just use the Mini-Mental [State] Examination or a global evaluation to assess patients and their treatments. We need to assess all domains [of Alzheimer's disease] to judge if patients should stop a treatment or change to another treatment," said Dr. Johannsen, a neurologist in the memory clinic at Aarhus University Hospital in Copenhagen.
The results also indicate that patients who do not appear to improve initially may "actually benefit from continued treatment with donepezil. It's important for physicians to understand that the benefits gained from therapy are often not evident until patients are treated and assessed over longer periods of time than just a few months," he said.
The study was sponsored by Pfizer and by Eisai, the companies that market donepezil (Aricept) in the United States, and was conducted in the United States and eight European countries.
The study began with 812 patients with mild to moderate Alzheimer's disease who all received 10 mg of donepezil a day for 12-24 weeks.
After at least 12 weeks of treatment, patients were assessed to determine their response to donepezil. Those who had a decline or no change from baseline in the MMSE and in their physician's global assessment were categorized as having "no apparent clinical benefit" from donepezil treatment. The 202 patients in this category were then entered into the second phase of the study.
In the second phase, patients were randomized to either continued treatment with 10 mg of donepezil daily or a placebo regimen. This phase ran for 12 weeks.
At the end of the second phase, the 99 patients who had continued donepezil treatment had an average two-point drop in their score on the Neuropsychiatric Inventory (NPI), compared with their score at the time of randomization.
The NPI assesses behavioral disturbances that often occur in patients with dementia, and the higher a patient's score on the NPI, the more severe the behaviors.
BY MITCHEL L. ZOLER
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|Title Annotation:||Geriatric Psychiatry|
|Author:||Zoler, Mitchel L.|
|Publication:||Clinical Psychiatry News|
|Date:||Oct 1, 2004|
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