“This was a well-powered, well-designed, and well-conducted trial,” that would have identified any benefit that existed, Dr. Wilcock said. Instead, its message seems to be that researchers would do well to investigate non–amyloid-centered therapies.
“It's one of three different strategic approaches to deal with amyloid in the brain that have proved negative,” Dr. Wilcock said. “Whether that is due to the study design, or means we need to be rethinking what is going on with the amyloid cascade hypothesis is an interesting question.”
The trial was sponsored by Myriad Pharmaceuticals Inc. of Salt Lake City. Dr. Wilcock is a consultant with the company.
Drug Combo No Better Than One Drug
Finally, a combination of two drugs already proven effective in Alzheimer's disease worked no better than a single agent to slow the disorder's cognitive and functional decline, Dr. Oliver Peters said.
Dr. Peters of Charité University Hospital Berlin, presented the results of a trial of a combination of galantamine and memantine, compared with galantamine alone, in 233 patients with mild to moderate Alzheimer's.
The patients (mean age 72 years) were randomized to 24 mg of galantamine daily plus a placebo, or a combination of 24 mg galantamine and 20 mg memantine for 1 year. The primary end points were the ADAS-cog, ADAS-ADL, and CDR-sb.
The combination was well tolerated, but the addition of memantine did not significantly affect any of the clinical end points.
“At 16 weeks, we saw a little better effect in the combination group,” on all three measures, although none of the differences were statistically significant, Dr. Peters said. After 16 weeks, patients in both treatment arms experienced steady declines which, by week 52, were significantly worse than their baseline scores.
Janssen-Cilag sponsored the trial. Dr. Peters said he had no financial relationship with the company.
The key to Alzheimer's will probably be preventing the disease from taking hold in the first place.
Source DR. GANDY