Masitinib in Patients With Mild to Moderate Alzheimer's Disease

Phase 3 Completed 721 enrolled AB Science

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the safety and efficacy of masitinib for the treatment of mild to moderate Alzheimer's Disease. Masitinib will be administered as add-on therapy in patients who have been treated for a minimum of 6 months with a stable dose of cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine.

Timeline

Start: 2012-01
Primary completion: 2020-12
Completion: 2020-12

Publications

Dubois B, Lopez-Arrieta J, Lipschitz S, Doskas T, Spiru L, Moroz S, Venger O, Vermersch P, Moussy A, Mansfield CD, Hermine O, Tsolaki M; AB09004 Study Group Investigators. Masitinib for mild-to-moderate Alzheimer's disease: results from a randomized, placebo-controlled, phase 3, clinical trial. Alzheimers Res Ther. 2023 Feb 28;15(1):39. doi: 10.1186/s13195-023-01169-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Masitinib	Small molecule	3 mg/kg	Oral
Subject	Masitinib	Small molecule	4.5 mg/kg	Oral
Subject	Masitinib	Small molecule	6 mg/kg	Oral
Background	Donepezil	Small molecule	—	—
Background	Galantamine	Small molecule	—	—
Background	Memantine	Unknown	—	—
Background	Rivastigmine	Small molecule	—	—

Masitinib in Patients With Mild to Moderate Alzheimer's Disease

Summary

Timeline

Publications

Drugs

Indications