Dear colleague,
I'm not participating in such a trail. However, French colleagues published a phase 2 study. In this article you will find aspects with regard to safety.
Regards, M. Arts
"To investigate the hypothesis that masitinib’s targeted inhibitory action on mast cells may reduce the symptoms of AD, its efficacy and safety was assessed as compared with a placebo. Masitinib was administered orally as an adjunct therapy to standard care in patients with mild-to-moderate AD."
"Blinded dose adjustments of 1.5 mg/kg/day were permitted according to efficacy and safety outcome, with the dosage being incremented in cases of insufficient response accompanied by minimal toxicity at weeks 4 and 8 to a maximum dose of 7.5 mg/kg/day (that is, one additional 100 mg tablet is required for a 66 kg patient
previously receiving 6 mg/kg/day to achieve the theoretical dose of 495 mg). Following predetermined criteria, treatment could be temporarily interrupted and/or the dosage decreased by 1.5 mg/kg/day in the event of toxicity."
"Safety was assessed throughout the study via physical examinations, vital signs, clinical laboratory evaluations and monitoring of adverse events (AEs), with all AEs recorded regardless of causality."
"Comparison of safety between the masitinib 3 and 6 mg/kg/day groups showed a similar overall frequency of AEs (69% vs. 62%, respectively); although there was a slightly elevated occurrence of severe AEs reported in the 6 mg/kg/day group, three patients (23%) compared with just one patient (8%) in the 3 mg/kg/day group."
"While the safety profile in the present study population showed a higher rate of toxicity (approximately 1.7-fold increase) with masitinib as an adjunct therapy compared with standard (placebo) therapy, the majority of AEs reported were mild to moderate and transient, with few severe side effects. The most frequent masitinib associated AEs were consistent with the known safety profile of tyrosine kinase inhibitors - notably oedema, rash, nausea, vomiting, and diarrhoea, which are generally considered manageable with symptomatic treatments."
Conclusions: "Masitinib, an oral tyrosine kinase inhibitor with high activity against mast cells, administered as add-on therapy to standard care during 24 weeks showed promising signs of retarding the rate of cognitive decline of AD with an acceptable tolerance profile. Masitinib may therefore represent an innovative avenue of treatment in AD. Confirmatory phase 3 trials are justified to further investigate the long-term efficacy and safety of masitinib as an adjunct therapy with cholinesterase inhibitors and/or memantine for treatment of mild-to-moderate AD."
Article:
Piette et al. Masitinib as an adjunct therapy for mild-to moderate Alzheimer’s disease: a randomised, placebo-controlled phase 2 trial. Alzheimer’s Research & Therapy 2011, 3:16.
I am not involved in that study, so I know nothing about. Carolina Garrett
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