Masitinib in Patients With Mild Alzheimer's Disease

Sponsor
AB Science
Study ID
NCT05564169
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    treatment per os
  • Masitinib (4.5) — DRUG
    Masitinib (titration to 4.5 mg/kg/day)
  • Standard of care — DRUG
    Cholinesterase inhibitors (donepezil, rivastigmine or galantamine) and/or memantine

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Sep 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Masitinib (4.5) & SOC
    Participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment. Dose up-titration is subjected to a safety control. Masitinib will be administered as an add-on to cholinesterase inhibitor and/or memantine standard of care (SOC).
  • Placebo Comparator: Placebo & SOC
    Participants receive a matched dose placebo, given orally twice daily. Placebo will be administered as an add-on to cholinesterase inhibitor and/or memantine standard of care (SOC).

Primary Outcome Measure

Absolute change from baseline in iADRS score at week 24 [ Time Frame: 24 weeks ]

Central Contacts

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