To: Dr. John M. de Castro who wrote (655 ) 8/18/1999 5:30:00 PM From: Dr. John M. de Castro Read Replies (1) | Respond to of 1494
Memantine.Com reports I just scanned through the Merz sitememantine.com It has be reformatted since the last time i visited the site and is much easier to use in accessing relevant information. Anyone who is invested in NTII or interested in the company, I urge you to take a careful look through this site. I found the following two abstracts of postmarketing clinical studies of memantine. They are nice indicators of just how safe and effective memantine is. John de C Rieke J., Glaser A.: Medwelt 47, 251-254 (1996) Efficacy and tolerability of memantine in patients with dementia Efficacy and tolerability of memantine have been evaluated in a post marketing surveillance study with 1420 dementia outpatients under the conditions of daily medical practice. Already within one month of treatment, memantine significantly improved memory, concentration, orientation, mood, sleep and motor functions, further improvement was achieved in the course of the treatment. Efficacy of memantine was rated by the physicans as good/very good in 70 %, tolerability in 94 % of cases respectively. Rüther E., Glaser A., 6th International Conference on Alzheimer's disease and related disorders, Amsterdam (1998) The NMDA-Antagonist Memantine in moderately severe and severe primary dementia: A prospective PMS-study to validate the sensitivity for change of the D-scale of change The present postmarketing surveillance (PMS) study is the first large scale systematic and prospective clinical trial of pharmacotherapeutic intervention in advanced stages of dementia. Within a validation program this study aimed at demonstrating the sensitivity of the D-scale of change (DS-C) for measuring ADL-function. Efficacy of treatment with memantine (1-amino-3,5-dimethyladamantane) was investigated in 531 patients with advanced dementia employing a parallel group design that stratified patient cohorts by severity according to GDS stages (Reisberg). Efficacy was determined on two independent levels: by the assessment of the physicians' Clinical Global Impression of Change (CGI-C) at the end of a 6-week observation period, and by the assessment of change in elementary ADL-functions by the caregivers using the D-scale of change. From 2 week treatment duration on the caregivers observed an improvement in all items of the D-scale of change, i. e. cognitive and motor functions and also elementary functions of daily life. The effect size of this improvement increased constantly during the observation period. Even patients of GDS stage 7 benefitted distinctly from the treatment with memantine. These results were also seen by the physicians, who recorded an overall clinical improvement in 75.5 % of the patients after 6 weeks. Tolerability evaluations resulted in the ratings "very well" by 59.5 % or "well" by 35.0 % of the patients. No serious adverse drug reactions occurred. A correlation analysis demonstrated a high congruency of both assessments. Furthermore the observed time course of these improvements paralleled with the time course of symptomatic benefit by effects of memantine that has been repeatedly demonstrated in randomised, double blind, placebo-controlled studies in mild to moderate dementia. Together with the evaluation of the scale-properties of the D-scale for assessment of severity the D-scale and the D-scale of change can be regarded as validated. Efficacy of Memantine GDS-Stage Improvement # of Patients GDS 5 87.3% 173 GDS 6 73.1% 264 GDS 7 60.0% 90