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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.

2014-08-27 03:13:54 | BioPortfolio

Summary

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.

Description

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 Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Alzheimer´s Disease

Intervention

Lornoxicam, Placebo

Location

JSW Lifesciences
Grambach
Styria
Austria
8074

Status

Recruiting

Source

JSW Lifesciences

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:54-0400

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