A 12-MONTH, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PROPENTOFYLLINE (HWA-285) IN PATIENTS WITH DEMENTIA ACCORDING TO DSM III-R

Alzheimer's disease (AD) and vascular dementia (VaD) share several fea tures such as overactivation of microglial cells, damage induced by fr ee radicals, glutamate and calcium overload. Propentofylline (HWA 285) has shown beneficial effects on all of these common elements, thus fa vouring its use in both subtypes of dementia. In a multinational, rand omized, 12-month, double-blind, parallel-group study 260 out-patients with mild to moderate AD or VaD received 300 mg propentofylline (n = 1 29) or placebo (n = 131) three times daily 1 h before meals. The effic acy was tested at four independent rater levels (physician, psychologi st, relative and patient) with assessments covering three major domain s of dementia (global function, cognitive function and activities of d aily living). After 12 months, the total patient population showed sta tistically significant treatment differences in favour of propentofyll ine for the global measures of dementia (Gottfries-Brane-Steen scale, GBS, p = 0.001; Clinical Global Impressions, CGI, item I: p = 0.004, i tem II: p = 0.072) as well as for the cognitive measures (Syndrome Sho rt Test, SKT, p = 0.002) and Mini-Mental State Examination (p = 0.001) . The activities of daily living also showed a significant treatment d ifference in favour of propentofylline (p = 0.002). No significant tre atment differences were found for rating scales performed by the patie nts. At month 12, VaD patients showed treatment differences in favour of propentofylline for the GBS total score (p = 0.006), CGI item I(p = 0.004), GGI item II (p = 0.044) and SKT (p = 0.028). Treatment differ ences for AD patients were all in favour of propentofylline and reache d statistical significance for the SKT (p = 0.018). Propentofylline sh owed a good safety profile with respect to adverse events, vital signs , ECG and laboratory changes.