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Biotech / Medical : Neurobiological Tech (NTII) -- Ignore unavailable to you. Want to Upgrade?

To: NeuroInvestment who wrote (358)	9/20/1998 3:24:00 PM
From: Dr. John M. de Castro	Read Replies (2) \| Respond to of 1494

Thanks for the note. Do you have a reference to a publication, abstract or news release on these data? I found the following on on the Merz Web site. I looks very similar. But, I would like to be able to look at more detailed data. John de C The uniquely broad action of Akatinol-Memantine® provides rapid and enduring improvement in the cognitive, psychological, social and motor impairments associated with dementia, and neuronal protection that may slow disease progression.* In a series of 4- or 6-week double-blind, placebo-controlled trials, over 400 patients with mild or moderate dementia classified as either Alzheimer's disease or vascular dementia were enrolled. In addition, a double-blind, placebo-controlled trial was conducted in a multicenter, Phase III study for 3 months in 168 care-dependent, moderately severe to severe patients with primary dementia. Outcomes were measured as the change in symptoms from baseline, comparing results in patients treated with Akatinol-Memantine® to those in patients given placebo. Patient changes were measured and confirmed by independent physician and caregiver assessments, using standardized scales that included Mini Mental State Evaluation (MMSE), Clinical Global Impression (CGI), Sandoz Clinical Assessment Geriatric Scale (SCAG), Instrumental Activities of Daily Living (I/ADL), Behavioral Rating Scale for Geriatric Patients (BGP) and Nurses Observation Scale for Inpatient Evaluation (NOSIE). In each trial, symptomatic measures showed initial patient improvement after 2 weeks, that continued to improve until the end of the double-blind trial. In a large, open clinical trial, symptomatic improvement was maintained until the end of the trial at week 60. Clinically and statistically significant improvements in cognitive, affective and functional disturbances were measured in the majority of patients. Clinically relevant effects were seen, not only in particular symptoms but also in the performance of daily living activities, social integration and independent self-care. Among care-dependent patients, coincident individual improvement in BGP and CGI evaluations was observed in 63% of patients receiving Akatinol-Memantine®. Only 32% of care-dependent patients in the placebo group achieved a response, as measured by these two independent ratings. Clinically relevant behavioral improvements in daily functioning, orientation and social competence correlated with the statistically significant therapeutic effects. Clinically and statistically significant improvements were reported for the majority of patients. The safety and tolerability of Akatinol-Memantine® also were tested in the double-blind, placebo-controlled trials and the long-term open trial. Reported side effects were mostly mild and transient. This has been confirmed by years of post-launch clinical experience and active surveillance of patients treated in Germany. Safety was assessed on the basis of physicians' global ratings of tolerability, monitoring of clinical laboratory values, and observed or spontaneously reported adverse events. Adverse events were recorded using the standardized scales, Dosage Record and Treatment Emergent Symptoms Scale (DOTES) and Treatment Emergent Symptoms Write-In Scale (TWIS). The most significant adverse drug effects were agitation or excitation, increased motor activity, sleeplessness and restlessness. These isolated events, transient and not serious, were manifestations of an excessive pharmacodynamic effect. For the most part, this can be avoided by introducing the treatment more gradually, titrating the dose upward. The safety and tolerability of Akatinol-Memantine® have been confirmed by clinical experience and active surveillance.