Study title: A multicentre double-blind, placebo-controlled, randomised, parallel-group study to evaluate the safety and efficacy of Lornoxicam in patients with mild to moderate probable Alzheimer's Disease.~Study phase: II~Indication: Alzheimer´s Disease~Study objectives: Primary:~To evaluate the efficacy of Lornoxicam (8 mg, BID) administered for 6 months versus matched placebo based on the following end-point:~• Cognitive performance - ADAS-cog+~Secondary:~To evaluate the efficacy of Lornoxicam (8 mg, BID) administered for 6 months versus matched placebo based on the following end-point:~Activities of daily living - ADCS-ADL~Behavioral / psychiatric symptoms - NPI~To evaluate the safety of Lornoxicam (8 mg, BID) administered for 6 months versus matched placebo.~• Overall incidence of adverse events.~Exploratory:~In a subgroup of 50 patients MRI analyses will be performed. In a subgroup of 50 patients exploratory data on the production of amyloid biological markers - blood plasma concentration of Aß1-38, Aß1-40 and Aß1-42 will be collected.~An optional 6 month open-label phase will be available.~Subject population, diagnosis and main criteria for inclusion: Male and female patients with mild to moderate probable Alzheimer's Disease according to NINCDS-ADRDA criteria~Age 50 - 85 years inclusive~MMSE 18-26 inclusive~No history of treatment with Acetylcholine-esterase inhibitors or 4 weeks wash out period before baseline visit.~No history of treatment with Memantine or 4 weeks wash out period before baseline visit.~Duration of treatment: 6 month double-blind phase 6 month open-label phase (optional)~Total number of subjects: A total of 220 patients will be recruited to the study from approximately 20 centers in a treatment ratio of 1:1 (8 mg BID, 110 : placebo, 110). This reflects the minimum number of patients required and also allows for a drop out rate of approximately 20%. Additional subjects may be recruited based on interim analysis.~Number of study centres: Approximately 20; multinational Europe~Number of visits: Doubble-Blind Phase: 5 visits (including screening); Open-Label Phase: 3 visits~Investigational product, dose schedule and route of administration: Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.~Reference product, dose, schedule and route of administration: Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
Study title: A multicentre double-blind, placebo-controlled, randomised, parallel-group study to evaluate the safety and efficacy of Lornoxicam in patients with mild to moderate probable Alzheimer's Disease.~Study phase: II~Indication: Alzheimer´s Disease~Investigational product, dose schedule and route of administration: Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.~Reference product, dose, schedule and route of administration: Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.