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CompletedPhase 3

Masitinib in Patients With Mild to Moderate Alzheimer's Disease

A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Phase 3 Study to Evaluate the Safety and Efficacy of Masitinib in Patients With Mild to Moderate Alzheimer's Disease

Lead sponsor

AB Science

Asset

Masitinib

Listed sites

6

Recruiting sites

-

Enrollment

721

actual

Study population

Alzheimer’s disease

Key I/E criteria

•MMSE 12-25•AD symptomatic therapy: stable ≥6 months

Primary endpoints

•ADCS-Activities of Daily Living (ADCS-ADL)•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDAB09004
NCT IDNCT01872598

Timeline

Milestones

Study start2012-01actual (month precision)
Study first posted2013-06-07estimated
Primary completion2020-12actual (month precision)
Study completion2020-12actual (month precision)
Last update posted2023-09-29actual

Assets

Drug assets

Masitinib

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

include:

1. Patient with dementia of Alzheimer's type, according to the Diagnostic and Statistical Manual of Mental Disorders criteria (DSM-IV)

2. Patient with probable Alzheimer' disease according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association criteria (NINCDS-ADRDA)

3. Patient with MMSE ≥ 12 and ≤ 25 at baseline

4. Patient treated for a minimum of 6 months with a stable dose of cholinesterase inhibitors (donepezil, rivastigmine or galantamine) at baseline, and/or a stable dose of memantine for a minimum of 6 months at baseline, with no changes foreseen in therapy throughout the study

Exclusion criteria

include:

1. Patient with any other cause of dementia not due to Alzheimer's disease.

2. Patient with Alzheimer disease with severe forms of delusions or delirium (patients with light and mild forms of delusions and delirium will be allowed in the study).

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
2
Function / daily living
1
Other clinical outcomes
1

Global cognition

2 endpoints
Primary/protocol endpoint

ADAS-Cog

Time frame:24 weeks

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

MMSE

Time frame:24 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

1 endpoint
Primary/protocol endpoint

ADCS-ADL

Time frame:24 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

CIBIC-plus

Time frame:24 weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.