Alzheimer´s Disease Clinical Trial
Official title:
A Multicentre Double-blind, Placebo-controlled, Randomised, Parallel-group Study to Evaluate the Efficacy and Safety of Lornoxicam in Patients With Mild to Moderate Probable Alzheimer´s Disease.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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