Masitinib in Patients With Mild to Moderate Alzheimer's Disease

NCT01872598 | Completed Phase 3 DMC

• 1 other identifier: AB09004
• Study Type: interventional
• Target: 721
• Locations: 6 countries
• Sites: 6

Brief Summary

The purpose of this study is to assess the safety and efficacy of masitinib for the treatment of mild to moderate Alzheimer's Disease. Masitinib will be administered as add-on therapy in patients who have been treated for a minimum of 6 months with a stable dose of cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine.

Conditions

Alzheimer Disease

Keywords

Alzheimer; dementia; cognitive disease; memory loss; cerebrovascular disease; tyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (2)

• ADCS-ADL

  Change in the Alzheimer's Disease Cooperative Study Activities of Daily Living score (ADCS-ADL).

  24 weeks

• ADAS-Cog

  Change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog).

  24 weeks

Secondary Outcomes (2)

• MMSE

  24 weeks

• CIBIC-plus

  24 weeks

Study Arms (5)

Masitinib escalating dose

EXPERIMENTAL

Participants receive masitinib at 4.5 mg/kg/day, given orally twice daily, with a dose escalation to 6 mg/kg/day after 3 months of treatment

Drug: Masitinib; Drug: Standard of care

Masitinib fixed dose (4.5 mg/kg/day)

EXPERIMENTAL

Participants receive masitinib at 4.5 mg/kg/day, given orally twice daily.

Drug: Masitinib; Drug: Standard of care

Masitinib fixed dose (3.0 mg/kg/day)

EXPERIMENTAL

Participants receive masitinib at 3.0 mg/kg/day, given orally twice daily.

Drug: Masitinib; Drug: Standard of care

Placebo (escalating dose)

PLACEBO COMPARATOR

Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment

Drug: Placebo; Drug: Standard of care

Placebo (fixed dose)

PLACEBO COMPARATOR

Participants receive fixed dose placebo, given orally twice daily

Drug: Placebo; Drug: Standard of care

Interventions

Masitinib DRUG

Also known as: AB1010

Masitinib escalating dose; Masitinib fixed dose (3.0 mg/kg/day); Masitinib fixed dose (4.5 mg/kg/day)

Placebo DRUG

Also known as: Placebo Oral Tablet

Placebo (escalating dose); Placebo (fixed dose)

Standard of care DRUG

stable dose of cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine, as per standard practice.

Masitinib escalating dose; Masitinib fixed dose (3.0 mg/kg/day); Masitinib fixed dose (4.5 mg/kg/day); Placebo (escalating dose); Placebo (fixed dose)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with dementia of Alzheimer's type, according to the Diagnostic and Statistical Manual of Mental Disorders criteria (DSM-IV)
• 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)
• Patient with MMSE ≥ 12 and ≤ 25 at baseline
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AB Science: lead

Study Sites (6)

MHAT Sveta Marina

Varna, 9010, Bulgaria

Location

General Hospital of Thessaloniki

Thessaloniki, 570 10, Greece

Location

Centrum Zdrowia Stołeczna 7

Bialystok, 15-879, Poland

Location

Spitalul Universitar de Urgenta Elias

Bucharest, 013686, Romania

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Municipal Institution Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnikov

Dnipropetrovsk, 49005, Ukraine

Location

Related Publications (1)

• Dubois B, Lopez-Arrieta J, Lipschitz S, Doskas T, Spiru L, Moroz S, Venger O, Vermersch P, Moussy A, Mansfield CD, Hermine O, Tsolaki M; AB09004 Study Group Investigators. Masitinib for mild-to-moderate Alzheimer's disease: results from a randomized, placebo-controlled, phase 3, clinical trial. Alzheimers Res Ther. 2023 Feb 28;15(1):39. doi: 10.1186/s13195-023-01169-x.

  PMID: 36849969 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognition Disorders; Memory Disorders; Cerebrovascular Disorders

Interventions

masitinib; Standard of Care

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Bruno DUBOIS, M.D., Ph.D.

  Pitié-Salpétrière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 7, 2013
• Study Start: January 1, 2012
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

UA (1); BU (1); GR (1); PL (1); RO (1); ES (1)