US EPA

7440644 

Journal Article 

Efficacy and safety results of the early phase studies with Exelon(TM) (ENA-713) in Alzheimer's disease: An overview 

Anand, R; Gharabawi, G; Enz, A 

1996 

Yes 

Journal of Drug Development and Clinical Practice
ISSN: 1357-9215 

8 

2 

109-116 

English 

WOS:A1996VJ32200006 

Exelon™ (SDZ ENA-713) is a new drug developed for the symptomatic treatment of mild to moderate Alzheimer's disease. The drug is a 'pseudo-irreversible, carbamate acetylcholinesterase inhibitor, which is selective for the CNS and has regional selectivity within the brain for cortex and hippocampus. Preliminary evidence of efficacy from two placebo-controlled studies in 516 patients is reported. Dato on tolerability reportée/ 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 (CCIC, Fuld-OME, DBS, CIBIC-plus, Weschler 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 I2mg/day, and it is suggested that the doses of 6-l2mg/day currently under investigation in several large, long-term studies are likely to prove both efficacious and well tolerated. 

Alzheimer's disease; ENA-713; clinical trial; efficacy