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Masitinib in Patients With Mild Alzheimer's Disease

ConditionAlzheimer Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorAB Science

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

A positive amyloid PET scan

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Masitinib (4.5) & SOCExperimental treatment 2 interventions
Group B: Placebo & SOCPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Absolute change from baseline in iADRS score at week 24

The iADRS is a linear combination of its two components: the ADAS-Cog11 and the ADCS-iADL. The iADRS is calculated as follows: iADRS = ADCS-iADL + (70 - ADAS-Cog11). Lower scores on the iADRS indicate greater impairment; iADRS scores range from 0 to 129.

Time frame
24 weeks

Secondary outcomes

1

Absolute change from baseline in Mini-Mental State Examination (MMSE) at week 24

Mini-Mental State Examination (MMSE) (scores from 0 to 30, with lower scores indicating poorer cognitive performance)

Time frame
24 weeks
2

Absolute change from baseline in ADAS-Cog11 score at week 24

The global score, which is the sum of the 11 items, ranges from 0 to 70, with higher scores indicating greater cognitive impairment.

Time frame
24 weeks
3

Absolute change from baseline in ADCS-ADL score

Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory scale (ADCS-ADL) (scores from 0 to 78, with lower scores indicating worse function)

Time frame
48 weeks
4

Clinical Responder rate

Clinical response defined as decrease from baseline at week 24 in ADAS-cog of ≥4, without deterioration in ADCS-ADL (ADCS-ADL change ≥ 0 between baseline and timepoint) or worsening in the CIBIC-plus scale (response CIBIC in 1-3\] or no change \[CIBIC in 4\]).

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AB Science

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: