Masitinib in Patients With Mild to Moderate Alzheimer's Disease

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

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

paper Masitinib (4.5 mg/kg/day) (n=182) showed significant benefit over placebo (n=176) according to the primary endpoint of ADAS-cog reads as mixed primary results PMID 36849969 ↗

paper For the ADCS-ADL primary endpoint, the between-group difference was 1.82 (97.5% CI [-0.15, 3.79]); p=0.038 reads as mixed primary results PMID 36849969 ↗

release “Study AB09004 was the first successful phase 3 randomized trial in mild-to-moderate Alzheimer’s disease” reads as met primary endpoint ab-science.com ↗

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	—	—

Indications