26-Week Extension Study of the Safety and Clinical Effects of EVP-6124
Research type
Research Study
Full title
A 26-Week Extension Study of the Safety and Clinical Effects of EVP-6124 in Subjects with Alzheimer’s Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication
IRAS ID
171455
Contact name
Roy Jones
Contact email
Sponsor organisation
Forum Pharmaceuticals Inc
Eudract number
2013-002654-75
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 0 days
Research summary
This is a 26-week, randomized extension of the EVP-6124-025 study. The EVP-6124-025 study was a double-blind placebo-controlled Phase 3 study for subjects diagnosed with mild to moderate dementia due to Alzheimer's Disease, who were currently or previously treated with an AChEI (donepezil, rivastigmine, or galantamine) who received EVP-6124 (2 or 3 mg daily) or placebo for 26 weeks. Participants who complete the previous study and fulfil all entry criteria are eligible for randomisation into this extension study; all participants will receive EVP-6124 2 or 3 mg daily. The term ‘randomised’ will refer to all subjects, including those previously treated with EVP-6124 who will continue the same dose, and participants previously treated with placebo who will be randomised to EVP-6124 2 or 3 mg (1:1 ratio). Investigators and study staff will remain blinded to the dose assignment for all participants. Each participant is required to have a reliable and capable support person/caregiver who interacts with them approximately 4 times per week and will be available to attend clinic visits, in person when possible. This is a fixed-dose study; however, study drug interruptions are allowed for safety reasons.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
15/EM/0094
Date of REC Opinion
2 Apr 2015
REC opinion
Further Information Favourable Opinion