AB09004 mild to moderate Alzheimer’s disease
Research type
Research Study
Full title
A multicenter, double-blind, placebo-controlled, randomised, parallel-group phase 3 study to evaluate the safety and efficacy of masitinib in patients with mild to moderate Alzheimer’s disease.
IRAS ID
126909
Contact name
Alain MOUSSY
Contact email
Sponsor organisation
AB Science
Eudract number
2010-021218-50
Duration of Study in the UK
2 years, 1 months, 3 days
Research summary
The purpose of this study is to compare the efficacy and the safety of an experimental drug called masitinib, to a so called placebo administered during 24 weeks to patients suffering from Alzheimer’s disease. A placebo is a substance which looks identical to the drug to be investigated but that does not contain any active ingredient.
There will be a total of 594 patients participating in this research study throughout the UK and/or other countries. These patients will be randomised into five (5) groups with each group receiving different dose of study drug or placebo. Study treatment will be given as add-on therapy in patients who have been treated for a minimum of 6 months with a stable dose of cholinesterase inhibitors (donepezil, rivastigmine or galantamine) and/or memantine, with no changes foreseen in therapy throughout the study.
During the 24 weeks of treatment , patients will have to visit the clinic at week 2, 4, 8, 12 and 24 for study procedures which includes physical exam, measurement of vital signs, ECG, blood and urine samples and neurological and neuropsychological exams or scales.
After 24 weeks of treatment period patients can still continue to receive the study treatment in extension phase if there is a significant improvement in their condition.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
14/SC/1031
Date of REC Opinion
7 Aug 2014
REC opinion
Further Information Favourable Opinion