To collect data on safety profile, behavioural symptoms and functioning under risperidone treatment in flexible doses in demented patients with vascular risk factors who have been unsatisfactorily pretreated with other neuroleptics.

Results of a 6-week, prospective observational study (RIS-DEM-0003). Clinical symptoms (aggression, hostility, distrust, agitation, delusion, sleep-wake-rhythm disturbances, social withdrawal, hallucinations, depression) and caregiver burden were measured and evaluated on a 5-point categorical scale.

787 outpatients (ITT; 58% with AD, 31% mixed, 9% vascular dementia, 2% other diagnoses; mean age±SD 80±9 years; 66% women) were documented. Most frequent vascular risk factors was hypertension (41%). Mean risperidone dose at endpoint was 1.2±0.6mg/day. Clinical symptoms improved significantly. Caregiver burden improved significantly (p<0.0001 vs. baseline) as well with respect to the criteria "wellbeing", "time burden", "carrying-out of other daily tasks", "social contacts" (p=0.02). 36 (4.2%) AEs and 16 SAEs were reported. Four SAEs in 2 patients were considered as at least possibly related to risperidone (cerebrovascular accident; confusional state, agitation, delirium). 4 patients had a fatal outcome (cerebrovascular accident in 1 patient assessed as possibly related to risperidone; death NOS in 2, heart failure in 1 patient without causal relationship). The incidence of cerebrovascular events was 0.13%, the mortality rate 0.51%.

In this observational study the transition from other neuroleptics to risperidone in demented patients with vascular risk factors was efficacious. The incidence of cerebrovascular events and mortality was not higher than what has been described for risperidone in controlled clinical studies (3.34% and 4% respectively over 12 weeks).