To evaluate the safety and efficacy of 2 fixed doses of EVP-6124

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 26-Week, Phase 3 Study of Two Doses of EVP-6124 or Placebo in Subjects with Mild to Moderate Alzheimer’s Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication

• IRAS ID

  143780

• Contact name

  Roy Jones

• Contact email

  r.w.jones@bath.ac.uk

• Sponsor organisation

  EnVivo Pharmaceuticals Inc

• Eudract number

  2013-002653-30

• Clinicaltrials.gov Identifier

  NCT01969136

• Research summary

  This is a randomized, double-blind, placebo-controlled, parallel-group, fixed-dose Phase 3 study to evaluate the safety and efficacy of EVP-6124 (2 or 3 mg daily) compared with placebo for 26 weeks in subjects with mild to moderate dementia due to AD.
  Approximately 790 subjects will be randomized to 1 of 3 groups (ratio 1:1:1) (n=263 per group) and subjects will be included in 1 of 2 baseline treatment strata. One stratum will include subjects currently treated with a stable dose of an AChEI (donepezil, rivastigmine, or galantamine) for at least 3 months before screening with total continuous exposure for at least 6 months.
  The second treatment stratum will include subjects previously treated with an AChEI. This study will evaluate the effects of EVP-6124 compared with placebo in subjects currently or previously treated with an AChEI. Subjects who have never received an AChEI are ineligible. Each subject is required to have a reliable and capable support person/caregiver who interacts with the subject approximately 4 times per week and will be available to attend clinic visits in person when possible. Study drug interruptions are allowed for safety reasons.

• REC name

  Scotland A REC

• REC reference

  14/SS/0049

• Date of REC Opinion

  9 Jul 2014

• REC opinion

  Further Information Favourable Opinion