S38093 in addition to Donepezil in Alzheimer's patients

• Research type

  Research Study

• Full title

  Efficacy and safety of 3 doses of S38093 (2, 5 and 20mg/day) versus placebo in co-administration with donepezil (10mg/day) in patients with moderate Alzheimer's Disease. A 24 week international, multi-centre, randomised, double-blind, placebo-controlled phase IIb study.

• IRAS ID

  107849

• Contact name

  Roy Jones

• Sponsor organisation

  Institute de Recherches Internationales Servier

• Eudract number

  2011-005862-40

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study aims to address two main questions: (1) is the drug S38093 effective in the treatment of Alzheimer's disease and (2) which is the most appropriate dose of the drug to be given to patients (three different doses are to be tested versus a dummy drug, or placebo, in co-administration of Donepezil). The patient's phyisician/neuropsychologist will carry out a number of memory (cognitive) and general lifestyle tests over this period in order to assess if the treatment is effective at slowing down the progression of the disease.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  12/SC/0435

• Date of REC Opinion

  22 Aug 2012

• REC opinion

  Favourable Opinion