Clinical Trials

This is an international, multicenter, randomized (1:1:1 ratio), double-blind, placebo controlled, three parallel group phase 3 study to compare the efficacy and safety of masitinib at two different doses in the treatment of patients with mild to moderate Alzheimer\'s disease. Study treatment will be given as add-on therapy to patients who have been treated for a minimum of 6 months with a stable dose of cholinesterase inhibitors (rivastigmine) and/or memantine, with no changes foreseen in therapy throughout the study.

The study aims at evaluating the effect of masitinib after 24 weeks of treatment on cognition and memory assessed by Alzheimer\'s Disease Assessment Scale (ADAS-Cog) and on self-care and activities of daily living assessed by Alzheimer\'s Disease Assessment Cooperative Study Activities on Daily Living (ADCS-ADL) at week-24.

* On February 9, 2015, AB Science announced the successful completion of a futility analysis related to the masitinib phase 3 trial for the treatment of mild to moderate Alzheimer’s disease. Based on these results, the Independent Data Safety Monitoring Committee (IDMC) has recommended the continuation of the study.The study is intended to enroll about 600 patients. The IDMC analysis was performed after about one third of the patients were enrolled into the study and had reached the 24 week treatment
duration period.
As a reminder, proof of concept for the evaluation of masitinib in Alzheimer’s disease was established through a 35 patient double-blind, placebo-controlled phase 2 study. In this study, the rate of clinically relevant cognitive decline, according to the primary endpoint, ADAS-Cog response (increase >4 points), was significantly lower with masitinib treatment compared with placebo after 12 and 24 weeks (6% versus 50% for both; p=0.040 and p=0.046, respectively). Moreover, while the placebo treatment-arm demonstrated worsening mean ADAS-Cog, ADCS-ADL and MMSE scores, the masitinib treatment-arm reported improvements with statistical significance between treatment-arms at weeks 12 and/or 24 (respectively, p=0.016 and 0.030; p=0.035 and 0.128; and p=0.047 and 0.031). Adverse events occurred more frequently with masitinib treatment (65% versus 38% of patients); however, the majority of events were mild or moderate and transient. The phase 2 results were published in Alzheimers Res Ther. 2011 Apr 19;3(2):16.

* On May 20, 2013, AB Science has announced the launch of a phase 3 clinical trial in the treatment of Alzheimer\'s disease with masitinib, as well as the recruitment of the first patients in this study in several countries. This study, for which recruitment has started in Europe and other countries, will enroll approximately 400 patients. In fact, the phase 3 study follows a phase 2 study, in which masitinib administered as an add-on therapy to standard care during 24 weeks showed promising signs of retarding the rate of cognitive decline of Alzheimer\'s disease as compared against placebo, with an acceptable tolerance profile. Improvement in cognitive function and functional capacity was seen in the masitinib treatment group, as evident through the sustained and statistically significant response in ADAS-Cog, as well as the mean change in ADAS-Cog and ADCS-ADL values relative to baseline. The objective of the double-blinded, randomized in parallel groups and placebo-controlled study was to evaluate masitinib, administered orally over 24 weeks, in patients suffering from mild-to-moderate Alzheimer\'s disease. Response was measured by change in ADAS-Cog, ADAS-ADL and MMSE scores after 24 weeks of treatment. A total of 35 patients were included in this study.

The rate of clinically relevant cognitive decline according to the primary endpoint, ADAS-Cog response (increase > 4 points), was significantly lower with masitinib treatment compared to placebo after 12 and 24 weeks (6% versus 50% for both; p=0.040 and p=0.046, respectively). Moreover, whilst the placebo treatment-arm showed worsening mean ADAS-Cog, ADCS-ADL, and MMSE scores, the masitinib treatment-arm reported improvements, with statistical significance between treatment-arms at weeks 12 and/or 24 (respectively, p=0.016 and 0.030; p=0.035 and 0.128; and p=0.047 and 0.031). Adverse events occurred more frequently with masitinib treatment (65% versus 38% of patients); however, the majority of events were mild or moderate and transient.