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Masitinib in Patients With Mild Alzheimer's Disease

NCT05564169 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-10-03

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Placebo

treatment per os

DRUG

Masitinib (4.5)

Masitinib (titration to 4.5 mg/kg/day)

DRUG

Standard of care

Cholinesterase inhibitors (donepezil, rivastigmine or galantamine) and/or memantine

Sponsors & Collaborators

  • AB Science

    lead INDUSTRY

Principal Investigators

  • Bruno Dubois, MD, PhD · Hôpital Universitaire Pitié-Salpêtrière, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • France
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05564169 on ClinicalTrials.gov