Tideglusib versus Placebo in Mild-to-Moderate Alzheimers Disease v0.0

• Research type

  Research Study

• Full title

  A multicenter, Randomized, Double-blind, Placebo-controlled, 4-arm, 26 week Parallel-Group Study to evaluate the Efficacy, Safety and Tolerability of Two Oral Doses and Two Regimes of Tideglusib vs Placebo in Mild-to-Moderate Alzheimer Disease Patients

• IRAS ID

  61085

• Contact name

  Simon Lovestone

• Sponsor organisation

  Noscira, S.A.

• Eudract number

  2010-023322-21

• ISRCTN Number

  isrctn

• Research summary

  This is a phase IIb study to see if Tideglusib at the doses and schedule in this study are safe, tolerable and effective in patients with mild to moderate Alzheimer's disease (AD). AD is a chronic progressive illness and is the most common form of dementia affecting 4-8% of the population over 65yrs. Outcome for the patient with AD is poor as the illness leads to loss of cognitive and intellectual ability and eventual loss of independence. Tideglusib is an irreversible inhibitor (permanently blocks the action) of GSK-3 which is a protein kinase that is though to be involved in the cellular pathways leading to the degeneration of brain function. This study aims to recruit patients aged between 50 and 85 years (patients out of this range could be included after a previous assessment by the investigator and approval by the sponsor). A total of 280 patients will be recruited in the European Union and randomise to one of four treatment groups in a 2:2:1:2 ratio after an initial screening period which will last 4 weeks maximum. Patients will either receive Tideglusib 1000mg once daily, Tideglusib 1000mg every other day, Tideglusib 500mg or placebo for a 26 week double-blind (neither the research team or patient knows which treatment is being given) period. The core treatment period is 26 weeks but the patients may continue in the study under blinded conditions for an optional extension period which can last up to a maximum of 39 additional weeks until the last patient in the study has completed the core 26 weeks of the study.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  11/H0709/9

• Date of REC Opinion

  15 Apr 2011

• REC opinion

  Further Information Favourable Opinion