October 29, 2002
Johnson & Johnson’s (NYSE: JNJ) Reminyl (galantamine) was unable to provide a treatment effect advantage for a primary functional Alzheimer Disease (AD) endpoint despite outperforming Pfizer (NYSE:
PFE) and Eisai’s Aricept (donepezil) on global cognitive and attention-related endpoints. This investigation was a one-year, rater-blinded, randomized clinical investigation of 182 patients with moderate to severe AD. These data were presented at a poster session of the 6th Congress of the European Federation of Neurological Societies in Vienna, Austria. Reminyl and Aricept are both cholinesterase inhibitors indicated for the treatment of mild to moderate AD. Reminyl is a second-generation cholinesterase inhibitor that may provide an improved treatment effect profile.
Reminyl’s treatment effect advantage for attention-related endpoints was shown at 6 and 52 weeks, and for global cognitive endpoints at 26 and 52 weeks. Notable also was a significant difference in effects on global cognition at 13 weeks, despite Aricept also contributing to improved global cognition, suggesting more sustained benefit for Reminyl recipients. The tools used to measure these endpoints were well-validated and included a computerized reaction time test and the mini-mental status examination.
However, despite these markers of achievement that appeared to favor Reminyl recipients, patients’ function – the ability to perform activities of daily living as measured by the Bristol Activities of Daily Living (BrADL) rating scale – was no different between the groups. Both agents had reassuring adverse effect and tolerability profiles.
This investigation indicates that, compared to Aricept, Reminyl provides a one-year attention and global cognitive benefit to recipients that does not translate into comparatively superior patient function for patients with moderate to severe AD. The clinical impact of these findings remain to be seen, but it is likely that Reminyl and Aricept provide a similar impact on the rate of functional decline in patients with moderate to severe AD.
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