Merz's Memantine for Severe Dementia PH III results are excellent!
I had NTII send me a copy of the publication of the Memantine trial results. For some reason the abstract has not shown up in Medline as yet so, sorry to disappoint you but I don't have one to post. The complete reference is:
Winblad, B. and Poritis, N. Memantine in severe dementia: results of the 9M-Best study (Benefit and Efficacy inSeverely Demented Patients during treatment with Memantine). International Journal of Geriatric Psychiatry, 14:135-146; 1999.
The results are simply outstanding. They are much better than I expected. First off there were no differences in side effects or adverse events between memantine and placebo treated patients and the documentation of safety is extensive. This is absolutely remarkable. Memantine is an NMDA antagonist. Drugs of this variety have a long history of failure due to side effects. This report documents that within the target population, memantine is indistinguishable from placebo. Amazing!
A lack of side effects would be meaningless if efficacy were not present. But, the paper establishes memantine's efficacy and demonstrates both statistically and clinically significant improvements in the memantine group. The types of end points used were caregiver ratings, physicians and nurses. These are not the individual patient oriented measures, such as psychometric test scores, that the FDA tends to prefer. So, the currently running Phase III trials include these endpoints that are missing from this trial. However, these ratings are very significant. The patients are severely demented and institutionalized. They have difficulty carrying out simple life functions and the nursing staff has to spend considerable time (the estimate is 58% of their time) helping these patients tend to the simplest of everyday functions. So, improvements in daily living measures are very significant for this kind of patient.
The results showed that the physicians detected an improvement in 73% of the patients receiving memantine while indicating improvement in 45% of the placebo group. The nurses also rated the memantine group as significantly more improved that the placebo group. In one measures of 16 specific behaviors that are a problem for demented patients, the memantine groups improvement was superior to the placebo group on every one of the measure, with 8 of them statistically significant. Around twice as many patients show improvement in ability to stand up, ability to move, ability to wash, ability to take a shower/bath, ability to dress, toilet use, orientation in space, engaging in group activities, and engaging in hobbies.
It should be clear from this list as to how significant these improvements must be for the nursing staff. Reduced staff time equates to reduced expense in caring for these patients. This is a great incentive for institutions to adopt such a treatment.
Another important aspect of the results were that the memantine treated patients continued to improve throughout the 12 weeks of the trial. The improvement was statistically significant at 5 weeks and continued up to 12 with no indication of slowing. In other words, a simple extrapolation of the improvement curve suggests that continued use of memantine would produce even greater improvements.
Finally, the type of patient didn't seem to matter. Memantine was just as effective in the treatment of Alzheimers Dementia patients as it was for vascular type dementia.
Needless to say, I'm very impressed. Most drugs fail due to safety reasons. (Take a look at SNAP's recent plummet due to safety problems with its migraine drug). Memantine showed no safety issues whatsoever. In addition, efficacy was statistically significant, but more importantly, clinically significant. These results have got to be impressive to potential marketing partners. There are no safety problems, clear efficacy, huge markets, requirements for chronic administration of the drug, and economic benefits for caregivers. Sounds like a winner to me.
Best regards
John de C |
