Background: Large randomized controlled trials have shown that risperidone reduces the frequency and severity of behavioral and psychological symptoms of dementia (BPSD) in patients with dementia. Since such trials are obliged to use very strict inclusion and exclusion criteria, their information about the efficacy is limited by the criteria used. Thus, the aim of the present study was to investigate the efficacy of risperidone on BPSD in a sample of patients routinely treated by their primary care physicians.

Methods: A total of 938 elderly patients in Austria suffering from BPSD and routinely treated by their primary care physicians were included in this open-label prospective study. Patients received a flexible dose of risperidone, starting with 0.5 mg daily, for at least 6 weeks. Questionnaires were filled in before the start and after 6 weeks of treatment.

Results: Before starting treatment with risperidone, BPSD were severe in 36.6% of the patients, moderate in 49.3%, and mild in 14.1%. The overall efficacy of risperidone was judged as “excellent” by the general practitioners and caregivers in about half the patients. The treatment was judged as “not satisfactory” in only a very small proportion (3.3% and 4.3%, respectively). According to the physicians' judgement, the tolerability of risperidone was “excellent” in 81.5% of the patients and “satisfactory” in 17.8%. The tolerability was “not satisfactory” in only 0.7% and only 7.4% of the patients reported any adverse event.

Discussion: Overall, the results of this survey indicate that risperidone is both efficacious and well tolerated for the treatment of elderly primary care patients with BPSD.