NCT01350362

Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease Patients

A Multicenter, Randomized, Double-blind, Placebo-controlled, 4-arm, 26 Week Parallel-Group Study to Evaluate Efficacy, Safety and Tolerability of 2 Oral Doses and 2 Regimes of Tideglusib vs Placebo in Mild-to-Moderate AD Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Noscira SA · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the cognitive changes after administration of tideglusib versus placebo at two oral doses and two treatment regimes for 26 weeks in patients with mild to moderate Alzheimer's disease. After the 26 week core treatment period, the patients may continue in the study under blinded conditions for an optional extension period up to a maximum of 39 additional weeks (total study duration up to 65 weeks), until the last patient in the study has completed the 26 week of treatment.

Detailed description

This double-blind, placebo-controlled, randomized, parallel group study will be conducted at multiple centers in the European Union. Patients with mild to moderate Alzheimer's disease will undergo a screening period, and then they will be randomized to one of these four groups: tideglusib 1000 mg once daily (Q.D.), tideglusib 1000 mg every other day (Q.O.D.), tideglusib 500 mg Q.D., or matching placebo, for a 26-week, double-blind, placebo-controlled treatment period.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	tideglusib	1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
DRUG	tideglusib	1000 mg of tideglusib as a powder for oral suspension once every other day in an overnight fasted state for 26 weeks/extension
DRUG	tideglusib	500 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
DRUG	Placebo	Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-07-01
• Completion: 2012-10-01
• First posted: 2011-05-09
• Last updated: 2012-10-02

Locations

6 sites across 6 countries: Belgium, Finland, France, Germany, Spain, United Kingdom