Interim analysis of a non-interventional study of risperidone (RIS) treatment of psychotic and behavioural symptoms in elderly patients with dementia and vascular risk factors previously treated with other neuroleptics

Objectives: There is a need to safely treat psychotic and behavioural symptoms in patients with dementia and vascular risk factors. The objective of this study was to collect naturalistic data on patients who were previously unsatisfactorily pretreated with other neuroleptics.

Methods: Interim analysis of a 6-week, prospective observational study (RIS-DEM-0003). Descriptive statistics used t-test and Wilcoxon-test for dependent samples. Vascular risk factors and insufficient treatment for severe chronic aggression or psychotic symptoms had to be present.

Results: 336 patients (ITT; 55% with AD, 35% mixed dementia, 10% vascular dementia; mean age±SD 81±9 years; 65% women) were documented. Most frequent vascular risk factors were hypertension (43%), cerebral micro- and/or macroangiopathy (33%), coronary heart disease (22%), diabetes mellitus (16%), TIA/cerebral infarction in patient history (18%) and smoking (16%). Mean±SD dose for RIS at endpoint was 1.2±0.6mg/d. Median scores of the following symptoms improved significantly: aggression, hostility, distrust, agitation, delusion, sleep disturbance, social withdrawal, hallucinations, depression. Caregiver burden improved significantly with respect to the criteria “wellbeing“, “time burden“ and “carrying-out of other daily tasks“. Patient's quality of life significantly improved with respect to most criteria (“patient's mood“, “access to other people“, “quality of life as compared to previous therapy“). In total, 25 (7.4%) treatment emergent adverse events (AE) [most frequent were EPS in 6 patients (1.8%)] and 5 serious AEs were reported.

Conclusions: The Interim analysis showed that the transition from other neuroleptics to RIS in demented patients with vascular risk factors was effective and tolerable. Furthermore QoL increased and caregiver's burden decreased.