Business
Neurochem announcement regarding the completion of its North American phase III clinical trial for tramiprosate (ALZHEMED(TM)) for the treatment of Alzheimer's disease
Neurochem announcement regarding the completion of its North American phase III clinical trial for tramiprosate (ALZHEMED(TM)) for the treatment of Alzheimer's disease.
About this update from Bluenergies Ltd.
[{"type":"text","content":"\n\n\n\nLAVAL, QC, Feb. 1 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX, TSX: NRM)\nannounces the completion of its 18-month North American Phase III clinical\ntrial for tramiprosate (ALZHEMED(TM)) for the treatment of Alzheimer's disease\n(AD). This study involved 1,052 patients, at 67 clinical sites across the\nUnited States and Canada. The drop-out rate in the study was 24.8% and 791\npatients were exposed to study medication for 18 months and completed their\nlast visit, as per protocol, except for two patients whose last study visits\nare anticipated next week. Neurochem is on schedule to release the top-line\nresults of the clinical trial in the spring of this year, as previously\nannounced. Tramiprosate (ALZHEMED(TM)) is the Company's innovative\ninvestigational product candidate aimed at arresting or stopping the\nprogression of AD.\n\n\nNeurochem's North American Phase III clinical trial is a multi-center,\nrandomized, double-blind, placebo-controlled, three-armed and parallel\ndesigned study. The primary objective of the clinical trial is to investigate\nthe safety, efficacy and disease-modifying potential of tramiprosate\n(ALZHEMED(TM)) for the treatment of mild-to-moderate AD patients. The patients\nwere randomized to receive either placebo or one of two different dose levels \n (100 mg or 150 mg twice daily) of tramiprosate (ALZHEMED(TM)) for a\nperiod of 18 months. All participants were treated with conventional AD\ntherapies during the clinical trial and were required to be on a stable dose\nof conventional therapies for at least four months prior to the initial\nscreening visit. At study entry, patients in this trial were on therapies for\nan average of approximately 20 months.\n\n\nThe primary efficacy endpoints of this study include the evaluation of\ncognitive abilities and a global measure of performance utilizing ADAS-cog(1)\nand CDR-SB scores(2), respectively. If treatment efficacy is established, the\ndisease modification effect of tramiprosate (ALZHEMED(TM)) will then be\nassessed by brain volume change from baseline as measured by magnetic\nresonance imaging.\n\n\nAn open-label Phase III extension study was initiated in May of 2006.\nApproximately 90% of the patients who completed the North American Phase III\nclinical trial have continued into the ongoing extension study and receive\ntramiprosate (ALZHEME...