Masitinib in Patients With Mild to Moderate Alzheimer's Disease
Alzheimer Disease
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer, dementia, cognitive disease, memory loss, cerebrovascular disease, tyrosine kinase inhibitor
Eligibility Criteria
Inclusion criteria include:
- 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.
Exclusion criteria include:
- 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).
Sites / Locations
- MHAT Sveta Marina
- General Hospital of Thessaloniki
- Centrum Zdrowia Stołeczna 7
- Spitalul Universitar de Urgenta Elias
- Hospital Universitario Ramón y Cajal
- Municipal Institution Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnikov
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Masitinib escalating dose
Masitinib fixed dose (4.5 mg/kg/day)
Masitinib fixed dose (3.0 mg/kg/day)
Placebo (escalating dose)
Placebo (fixed dose)
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
Participants receive masitinib at 4.5 mg/kg/day, given orally twice daily.
Participants receive masitinib at 3.0 mg/kg/day, given orally twice daily.
Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment
Participants receive fixed dose placebo, given orally twice daily