Masitinib in mild to moderate Alzheimer's disease
Research type
Research Study
Full title
A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 study to evaluate the safety and efficacy of masitinib as add-on therapy in patients with mild to moderate Alzheimer's disease, treated with standard of care: cholinesterase inhibitors, memantine
IRAS ID
1006142
Contact name
Daouia Adjerious
Contact email
Sponsor organisation
AB Science
Eudract number
2021-002179-21
Research summary
Alzheimer's disease is the result of slow neuron degeneration, which starts in the hippocampus (a cerebral structure essential for memory) and then spreads to the rest of the brain. The patient gradually loses their cognitive faculties and autonomy. Clinical dementia severity can be assessed by different areas it affects like memory, orientation, judgement and problem solving, involvement in community affairs, function in home and hobbies, and self-care.
There is no cure for Alzheimer disease and currently no disease-modifying treatment exists. However, there are several therapeutic agents that can be used to slow disease progression or to alleviate symptoms.
Masitinib is a new chemical entity under development in progressive forms of multiple sclerosis, other neurodegenerative conditions such as amyotrophic lateral sclerosis and Alzheimer’s disease, as well as severe asthma, systemic mastocytosis, and as an anti-cancer agent.
Phase 2 study with masitinib showed that masitinib in combination with a cholinesterase inhibitor significantly slowed the cognitive deterioration in patients with mild-to-moderate Alzheimer’s disease. 719 patients were treated so far in clinical trials.REC name
London - Riverside Research Ethics Committee
REC reference
22/LO/0800
Date of REC Opinion
22 Nov 2023
REC opinion
Further Information Favourable Opinion