Activity of Masitinib (AB1010) in Mild to Moderate Alzheimer's Disease

AB Science

Status and phase

Completed

Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: placebo

Drug: masitinib (AB1010)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00976118

AB04024

Details and patient eligibility

About

This phase 2 study was designed to evaluate the activity of oral masitinib (AB1010) administered at 2 dose levels during 24 weeks to patients with mild to moderate confirmed Alzheimer's type disease.

Enrollment

34 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Outpatients from both sex
Age ≥ 50 years at screening
Menopause ≥ 2 years for women
Dementia of Alzheimer's type, according to DSM IV criteria
Probable Alzheimer' disease according to NINCDS-ADRDA criteria
MMSE ≥ 12 and ≤ 26 at baseline
CDR of 1 or 2 at baseline
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 3 months at baseline, with no changes foreseen in therapy throughout the study
Presence of a reliable caregiver
Patient, identified caregiver and, if applicable, patient surrogate are able and willing to comply with study visits and procedures per protocol, understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed
Affiliated to the French Social Security regimen

Exclusion criteria

Any cause of dementia not due to Alzheimer's disease :
- other central nervous conditions causing progressive deficits in memory and cognition, e.g. cerebrovascular disease, Parkinson's disease, Huntington's disease, brain tumor...
- systemic conditions known to cause dementia, e.g., hypothyroidism, untreated vitamin B12 or folic acid deficiency, niacin deficiency, neurosyphilis, HIV infection...
- substance-induced conditions
Alzheimer disease with delusions or delirium
Treatment with any registered or putative cognitive enhancer or disease modifier other than donepezil, galantamine, rivastigmine or memantine
Uncontrolled depression at screening
Evidence of psychosis and/or use of antipsychotic drugs at screening, or history of significant psychotic disorder or hospitalization for psychiatric disorders
Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection.
History of infection requiring hospitalization or treatment with antibiotics within 2 weeks of screening
Inadequate organ function, defined as follows : total bilirubin ≥ 1.5 x ULN, SGOT and SGPT ≥ 2.5 x UNL, creatinine clearance calculated by Crocroft method < 35 ml/mn, ANC ≤ 2500, platelets ≤ 100 000 at baseline
Treatment with any investigational agent within 4 weeks of screening,
Men and their partner refusing to use 2 methods of medically acceptable forms of contraception during the study.
History of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
Any condition that, in the investigator's opinion, could be detrimental to subjects participating in this study as life expectancy < 1 year, or any clinically important deviations from normal clinical laboratory values or concurrent medical events.