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

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ClinicalTrials.gov Identifier: NCT00976118
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : May 22, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: masitinib (AB1010) Drug: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adults Patients With Mild to Moderate Alzheimer-type Disease.
Study Start Date : February 2006
Primary Completion Date : July 2008
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: placebo Drug: placebo
matching placebo to masitinib
Experimental: oral masitinib (AB1010)
masitinib (AB1010) 3 or 6 mg/kg/day
Drug: masitinib (AB1010)
oral masitinib 3 or 6 mg/kg/day
Other Name: AB1010


Outcome Measures

Primary Outcome Measures :
  1. change from baseline in ADAS-Cog [ Time Frame: week 24 ]

Secondary Outcome Measures :
  1. change from baseline in ADAS-Cog [ Time Frame: week 4 and 12 ]
  2. change from baseline in CIBIC-plus [ Time Frame: week 4, 8, 12 and 24 ]
  3. change from baseline in CDR [ Time Frame: week 12, 24 ]
  4. change from baseline in MMSE [ Time Frame: week 4, 12 and 24 ]
  5. change from baseline in NPI [ Time Frame: week 12 and 24 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Outpatients from both sex
  2. Age ≥ 50 years at screening
  3. Menopause ≥ 2 years for women
  4. Dementia of Alzheimer's type, according to DSM IV criteria
  5. Probable Alzheimer' disease according to NINCDS-ADRDA criteria
  6. MMSE ≥ 12 and ≤ 26 at baseline
  7. CDR of 1 or 2 at baseline
  8. 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
  9. Presence of a reliable caregiver
  10. 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
  11. Affiliated to the French Social Security regimen

Exclusion Criteria:

  1. 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
  2. Alzheimer disease with delusions or delirium
  3. Treatment with any registered or putative cognitive enhancer or disease modifier other than donepezil, galantamine, rivastigmine or memantine
  4. Uncontrolled depression at screening
  5. Evidence of psychosis and/or use of antipsychotic drugs at screening, or history of significant psychotic disorder or hospitalization for psychiatric disorders
  6. Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection.
  7. History of infection requiring hospitalization or treatment with antibiotics within 2 weeks of screening
  8. 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
  9. Treatment with any investigational agent within 4 weeks of screening,
  10. Men and their partner refusing to use 2 methods of medically acceptable forms of contraception during the study.
  11. 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
  12. 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.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT00976118     History of Changes
Other Study ID Numbers: AB04024
First Posted: September 14, 2009    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: September 2009

Keywords provided by AB Science:
Dementia of Alzheimer's type
mild to moderate Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders