A Phase 3 Study to Evaluate the Safety and Efficacy of Masitinib in Patients With Mild to Moderate Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT01872598 |
Recruitment Status
: Unknown
Verified June 2013 by AB Science.
Recruitment status was: Recruiting
First Posted
: June 7, 2013
Last Update Posted
: June 7, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer Disease | Drug: Group 1 Drug: Group 2 Drug: Group 3 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 396 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Double-blind, Placebo-controlled, Randomised, Parallel-group Phase 3 Study to Evaluate the Safety and Efficacy of Masitinib in Patients With Mild to Moderate Alzheimer's Disease |
Study Start Date : | January 2012 |
Estimated Primary Completion Date : | December 2015 |
Estimated Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 1
Masitinib 3mg/kg/day
|
Drug: Group 1
Other Name: Masitinib 3 mg/kg/day
|
Experimental: Group 2
Masitinib 4.5mg/kg/day
|
Drug: Group 2
Other Name: Masitinib 4.5 mg/kg/day
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Placebo Comparator: Group 3
Placebo 3 mg or 4.5mg/kg/day
|
Drug: Group 3
Other Name: Placebo 3 or 4.5 mg/kg/day
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- Cognition and Memory assessment [ Time Frame: Week 24 ]Effect on cognition and memory assessed by Alzheimer's disease Assessment Scale (ADAS-Cog)
- Self-care and daily activities assesment [ Time Frame: Week 24 ]Effect on self-care and activities of daily living assessed by Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female patient
- Age ≥ 50 years, weighing more than 49,9 kg and with a Body Mass Index (BMI) >18
- Patient and/ or caregiver able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months
- Menopause ≥ 2 years for female patient
- Patient with dementia of Alzheimer's type, according to DSM-IV criteria
- Patient with probable Alzheimer' disease according to NINCDS-ADRDA criteria
- MMSE ≥ 12 and ≤ 25 at baseline
- Patient treated for a minimum of 6 months with a stable dose of cholinesterase inhibitors (rivastigmine) 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
-
Patient with adequate organ function at screening and baseline:
- Absolute Neutrophils Count (ANC) ≥ 2 x 109/L
- Hemoglobin ≥ 10 g/dL
- Platelets (PTL) ≥ 100 x 109/L
- AST/ALT ≤ 2.5 ULN
- Bilirubin ≤ 1.5 ULN
- Albuminemia > 1 x LLN
- Urea ≤ 1.5 x ULN
- Creatinin clearance > 60 mL/min (Cockcroft and Gault formula)
- Proteinuria < 30 mg/dL on dipstick; in case of the proteinuria ≥ 30mg/dL, 24 hours proteinuria < 1.5g/24 hours
- Patient with a regular and reliable caregiver. The designated caregiver must be sufficiently familiar with the patient (as determined by the investigator) to provide accurate data. The caregiver must have regular contact with the patient (i.e., an average of 10 or more hours per week), must be able to observe for possible adverse events, must be able to oversee patient's compliance with the study treatment and to report on the patient's status and must be able to accompany the patient to all visits
- Patient, identified caregiver and, if applicable, patient surrogate able and willing to comply with study visits and procedures per protocol, understand, sign, and date the informed consent form at the screening visit prior to any protocol-specific procedures performed
- Male patient must agree to use one method of medically acceptable forms of contraception (his partner must also use one if she is of child-bearing potential) during the study and for 3 months after the last treatment intake.
Exclusion Criteria:
-
Patient with any other cause of dementia not due to Alzheimer's disease, based on specific examination including a brain neuro-imagery exam within the last 6 months:
- Other central nervous condition causing progressive deficits in memory and cognition, e.g. cerebrovascular disease (patient with not more than 4 microbleeds and not more than 2 lacunes at the MRI could be enrolled in the study), 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 dementia
- 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
- Patient treated with any registered or putative cognitive/memory enhancer or disease modifier other than rivastigmine or memantine. (Patients taking Ginkgo Biloba can be enrolled providing it has been taken at a stable dose for at least 6 months
- Patient with evidence of psychosis and/or use of antipsychotic drugs at screening, or history of significant psychiatric disorder
- Patient with active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster), fungal, mycobacterium, protozoan, or other infection
- Patient with history of infection requiring hospitalization within 2 weeks of screening
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Patient presenting with cardiac disorders defined by at least one of the following conditions:
-
Patient with recent cardiac history (within 6 months) of:
- Acute coronary syndrome
- Acute heart failure (class III or IV of the NYHA classification)
- Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
- Patient with cardiac failure class III or IV of the NYHA classification
- Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
- Syncope without known aetiology within 3 months
- Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
-
- Patient with chronic diarrhea
- Patient presenting with oedemas
- Patient with co existing dermatological disease (e.g. eczema, psoriasis) or history of skin allergy
- Patient with 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
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Patient with life expectancy < 1 year
Previous medications:
- Patient treated with any investigational agent within 4 weeks of screening

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872598
Contact: Bruno DUBOIS, M.D., Ph.D. | bruno.dubois@psl.aphp.fr |
Spain | |
Hospital Universitario Ramón y Cajal | Recruiting |
Madrid, Spain, 28034 | |
Principal Investigator: Alfonso CRUZ, MD |
Principal Investigator: | Bruno DUBOIS, M.D., Ph.D. | Pitié-Salpétrière |
Responsible Party: | AB Science |
ClinicalTrials.gov Identifier: | NCT01872598 History of Changes |
Other Study ID Numbers: |
AB09004 |
First Posted: | June 7, 2013 Key Record Dates |
Last Update Posted: | June 7, 2013 |
Last Verified: | June 2013 |
Keywords provided by AB Science:
Alzheimer dementia cognitive disease memory loss cerebrovascular disease |
Additional relevant MeSH terms:
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |