Activity of Masitinib (AB1010) in Mild to Moderate Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
masitinib (AB1010)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Dementia of Alzheimer's type, mild to moderate Alzheimer's Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
oral masitinib (AB1010)
Arm Description
masitinib (AB1010) 3 or 6 mg/kg/day
Outcomes
Primary Outcome Measures
change from baseline in ADAS-Cog
Secondary Outcome Measures
change from baseline in CIBIC-plus
change from baseline in CDR
change from baseline in MMSE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00976118
Brief Title
Activity of Masitinib (AB1010) in Mild to Moderate Alzheimer's Disease
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 Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Science
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Dementia of Alzheimer's type, mild to moderate Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
oral masitinib (AB1010)
Arm Type
Experimental
Arm Description
masitinib (AB1010) 3 or 6 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
masitinib (AB1010)
Other Intervention Name(s)
AB1010
Intervention Description
oral masitinib 3 or 6 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
matching placebo to masitinib
Primary Outcome Measure Information:
Title
change from baseline in ADAS-Cog
Time Frame
week 24
Secondary Outcome Measure Information:
Title
change from baseline in CIBIC-plus
Time Frame
week 24
Title
change from baseline in CDR
Time Frame
week 24
Title
change from baseline in MMSE
Time Frame
week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
21504563
Citation
Piette F, Belmin J, Vincent H, Schmidt N, Pariel S, Verny M, Marquis C, Mely J, Hugonot-Diener L, Kinet JP, Dubreuil P, Moussy A, Hermine O. Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial. Alzheimers Res Ther. 2011 Apr 19;3(2):16. doi: 10.1186/alzrt75.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3226277/
Description
Publication of results
Learn more about this trial
Activity of Masitinib (AB1010) in Mild to Moderate Alzheimer's Disease
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