Objective: Donepezil, a selective acetylcholinesterase inhibitor, is approved for the symptomatic treatment of mild-to-moderate Alzheimer’s disease (AD) in over 50 countries. Little guidance exists on how to judge treatment response in everyday clinical practice outside of clinical dementia trials. We compared the individualized treatment response in each patient after 2 different observation periods: 3 months versus 6 months after initiation of donepezil therapy.
Design: 2029 patients were observed in this 3rd German Post Marketing Surveillance (PMS) study (3GPMS).
Materials and Methods: 1859 patients were included in the efficacy evaluation. For each patient, up to 3 individual symptoms were defined at baseline for which improvement was a desirable treatment goal. These symptoms were judged after 3 months and after 6 months on a 5-point Likert-type scale (2 = markedly improved, 1 = somewhat improved, 0 = unchanged, -1 = somewhat worsened, -2 = markedly worsened). The mean symptom score for each patient at any given visit after baseline is defined as the Individualized Symptom Score (IndiSS).
Results: 5301 IndiSS items (symptoms) were defined at baseline for 1850 patients (mean, 2.87 per patient). The mean (± SD) IndiSS score for the overall patient population was +0.7 (± 0.7) points after 3 months (n = 1841) and +0.9 (± 0.8) after 6 months (n = 1719), indicating improvements in most of the selected symptoms. The difference between the 3- and 6-month evaluations was most pronounced for the following IndiSS items: affective disorder (3m: +0.9, 6m: +1.3), loss of initiative/apathy (3m: +0.8, 6m: +1.1), social withdrawal (3m: +0.9, 6m: +1.2), aggressive behavior (3m: +0.9, 6m: +1.2), and stubbornness (3m: +0.7, 6m: +1.0). In comparison, the IndiSS item ²memory² improved by +0.6 points (after 3 months) and +0.7 (after 6 months). As in all previous studies, donepezil was very well tolerated.
Conclusion: These results suggest that individually tailored treatment goals to define response to donepezil treatment are useful. They also suggest that the observable treatment effect is greater after 6 months following initiation of donepezil therapy compared with 3 months, especially for noncognitive (behavioral) symptoms. We recommend an observation period of at least 6 months of donepezil therapy before judging treatment response.
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