Donepezil in Alzheimer's disease: a clinical observational study evaluating individual treatment response.

OBJECTIVE

A post-marketing surveillance study evaluating the sensitivity of the Individual Symptom Score (IndiSS) in assessing the treatment benefits of donepezil in patients with Alzheimer's disease (AD) under everyday conditions.

RESEARCH DESIGN AND METHODS

For each patient, up to three 'especially relevant' individual symptoms were defined and evaluated during donepezil treatment. Changes were scored on a five-point Likert-type scale, ranging from 'markedly improved' (+2) to 'markedly worsened' (-2). The mean score for all IndiSS items was calculated after 3 and 6 months. Positive values represented treatment success. In addition, patients with concomitant parkinsonian symptoms (PS+) or cerebrovascular disease (CVD+) were compared with those with neither condition.

RESULTS

A total of 2046 patients with AD enrolled. The most frequent IndiSS items were (% patients): memory (24%), disorientation (14%) and loss of initiative/apathy (9%). The mean IndiSS for the overall patient population was +0.7 +/- 0.7 points after 3 months and +0.9 +/- 0.8 after 6 months. Patients with concomitant PS+ or CVD+ showed similar improvements in IndiSS.

CONCLUSION

Identification and follow-up of individual symptoms is a useful tool for evaluating therapy response to donepezil in everyday practice. Patients with concomitant PS+ or CVD+ benefit from donepezil therapy and show a similar side-effect profile.