Masitinib added to usual treatment for mild Alzheimer's disease
Tests masitinib alongside standard medicines in people with mild Alzheimer's disease.
Plain-language title generated from the registry record
Registry title: Masitinib in Patients With Mild Alzheimer's Disease
Key facts
- Where
- Albacete, Barcelona, Donostia / San Sebastian, Granada, Madrid, Murcia, Pamplona, and Zamora, SpainSee the 8 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with mild Alzheimer's disease who already take standard Alzheimer's medicine. They would also receive masitinib or a placebo.
- Age
- 50 years or older
- Sex
- All sexes can join
- Disease stage
- Alzheimer's disease diagnosed by the International Working Group criteria. Mild stage: MMSE score from 21 to 25 and ADCS-ADL score below 73.
- Earlier treatment
- If taking cholinesterase inhibitors (donepezil, rivastigmine or galantamine) or memantine, the dose must have been stable for at least 6 months. Cognition supplements need a stable dose for at least 4 months before screening.
- Biomarker or test result
- Alzheimer's biomarker profile: a positive amyloid PET scan, or positive a-beta and p-tau results, or an abnormal p-tau/a-beta ratio in spinal fluid (CSF).
Main reasons for not taking part
- Any other cause of dementia seen on MRI or neurological exam
- Systemic conditions known to cause dementia, including HIV infection
- Substance-induced dementia, severe delusions, psychosis or antipsychotic use, or a significant psychiatric history
- Unexplained big improvement or decline in ADAS-Cog and ADCS-ADL scores compared with earlier assessments
- No caregiver who agrees to come to all visits and help with the trial
Read by machine on 9 November 2026.
Where in Spain
- Hospital Universitario Nuestra Señora del Perpetuo Socorro de Albacete (Hospital Universitario Nuestra Señora del Perpétuo Socorro)Albacete, SpainNo longer taking part
- Ace Alzheimer Center Barcelona (Fundació ACE)Barcelona, SpainNo longer taking part
- Hospital Policlínico de GipuzkoaDonostia / San Sebastian, SpainNo longer taking part
- Virgen de las Nieves University Hospital (Hospital Universitario Virgen de las Nieves)Granada, SpainNo longer taking part
- La Paz University Hospital (Hospital Universitario La Paz)Madrid, SpainNo longer taking part
- Hospital Clínico Universitario Virgen de la ArrixacaMurcia, SpainNo longer taking part
- Hospital Universitario de NavarraPamplona, SpainNo longer taking part
- Complejo Asistencial de Zamora. Hospital Provincial de ZamoraZamora, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AB Science
- Trial code
- NCT05564169
- Record updated
- 3 October 2025
- Original description
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.Read full original descriptionShow less
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
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.
Main inclusion criteria include:; Patient with clinical diagnosis of Alzheimer's disease based on criteria defined by IWG (International Working Group on Alzheimer's disease) at screening visit; Patients with ADCS-ADL score at screening visit and baseline visit < 73; Patient with MMSE ≥ 21 and ≤ 25 at screening visit and baseline visit; Patient with Alzheimer's Disease biomarker profile at screening visit:; A positive amyloid PET scan; Alternatively, positive a-beta AND p-tau results OR an abnormal p-tau/a-beta ratio in CSF analysis. Before randomization, the results will be verified centrally; If patients are treated with cholinesterase inhibitors (donepezil, rivastigmine or galantamine), and/or memantine. They should have been at stable dose for a minimum of 6 months at baseline visit, with no changes foreseen in therapy throughout the trial; If receiving a supplement for cognition (eg, gingko biloba, omega-3 polyunsaturated fatty acid, vitamin E, curcumin, souvenaid) patients must have been taking it at stable dose for at least 4 months prior to screening visit; Patients with a caregiver who, at screening and baseline visits, agrees to accompany the participant to all trial visits, supervise compliance with procedures, provide detailed information, has sufficient contact (≥1 hour/day for ≥3 days/week or as deemed sufficient by the Investigator), can read, understand, and speak the designated language, and is cognitively capable of fulfilling trial requirements; Main exclusion criteria include:; Related to disease; Patients with any other cause of dementia shown by MRI findings and neurological examination; Systemic conditions known to cause dementia, e.g., hypothyroidism, untreated vitamin B12 or folic acid deficiency, niacin deficiency, neurosyphilis, HIV infection at screening visit; Patients with substance-induced dementia, Alzheimer's disease with delirium, severe delusions (e.g., NPI delusion score ≥ 4), psychosis or antipsychotic use, or a history of significant psychiatric disorders at the screening visit; Patients with a significant unexplained improvement or decline in overall status on ADAS-Cog and ADCS-ADL at screening and baseline compared to previous assessments, and those whose scores are not in line with their medical history.