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Masitinib in Patients With Mild Alzheimer's Disease
Sponsor: AB Science
Summary
Masitinib is an orally administered tyrosine kinase inhibitor that targets activated cells of the neuroimmune system (mast cells and microglia). Study AB21004 will evaluate masitinib as an adjunct to cholinesterase inhibitor and/or memantine in patients with mild-to-moderate Alzheimer's disease.
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Masitinib as add-on Therapy in Patients With Mild Alzheimer's Disease, Treated With Standard of Care
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2026-06
Completion Date
2029-12
Last Updated
2025-10-03
Healthy Volunteers
No
Conditions
Interventions
Placebo
treatment per os
Masitinib (4.5)
Masitinib (titration to 4.5 mg/kg/day)
Standard of care
Cholinesterase inhibitors (donepezil, rivastigmine or galantamine) and/or memantine
Locations (9)
Institut de la mémoire et Maladie d'Alzheimer, Hôpitaux Universitaires Pitié-Salpêtrière
Paris, France
Hospital Universitario Nuestra Señora del Perpetuo Socorro de Albacete (Hospital Universitario Nuestra Señora del Perpétuo Socorro)
Albacete, Spain
Ace Alzheimer Center Barcelona (Fundació ACE)
Barcelona, Spain
Hospital Policlínico de Gipuzkoa
Donostia / San Sebastian, Spain
Virgen de las Nieves University Hospital (Hospital Universitario Virgen de las Nieves)
Granada, Spain
La Paz University Hospital (Hospital Universitario La Paz)
Madrid, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, Spain
Hospital Universitario de Navarra
Pamplona, Spain
Complejo Asistencial de Zamora. Hospital Provincial de Zamora
Zamora, Spain