EFFICACY AND SAFETY RESULTS OF THE EARLY PHASE STUDIES WITH EXELON(TM) (ENA-713) IN ALZHEIMERS-DISEASE - AN OVERVIEW

Exelon(TM) (SDZ ENA-713) is a new drug developed for the symptomatic t reatment of mild to moderate Alzheimer's disease. The drug is a 'pseud o-irreversible', carbamate acetylcholinesterase inhibitor, which is se lective for the CNS and has regional selectivity within the brain for cortex and hippocampus. Preliminary evidence of efficacy from two plac ebo-controlled studies in 516 patients is reported. Data on tolerabili ty reported here ore from the two efficacy studies and a third safety/ tolerability study in 50 patients. Doses of 3mg bid Produced evidence of efficacy on global symptoms and was effective according to a number of tests of cognitive function (CGIC, Fuld-OME DSS, CIBIC-plus, Wesch ler logic memory test). However, this dose was well tolerated, and it is therefore likely that higher doses would have produced more robust evidence of efficacy. ENA-713 was well tolerated in patients with mild to moderate Alzheimer's disease in all three studies described here. The highest dose used was 12mg/day, and it is suggested that the doses of 6-12mg/day currently under investigation in several large, long-te rm studies are likely to prove both efficacious and well tolerated.