Clinical Trial: A Phase 3 Study to Evaluate the Safety and Efficacy of Masitinib in Patients With Mild to Moderate Alzheimer's Disease

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: The objective is to compare the efficacy and safety of oral masitinib 3 or 4.5 mg/kg/day in combination with cholinesterase inhibitors and/or memantine to placebo in combination with cholinesterase inhibitors and/or memantine in patients with mild-to-moderate Alzheimer's disease.

Detailed Summary: Actual standard treatment for mild to moderately severe Alzheimer's dementia includes acetylcholinesterase inhibitors (donepezil, rivastigmine and galantamine) and a NMDA receptor antagonist (memantine for moderate to severe Alzheimer's disease). These medications have shown to have an effect on some cognitive and non cognitive symptoms of the pathology. However, their efficacy remains limited and may decrease with time. There is an unmet medical need in this pathology. Based on pre-clinical and clinical studies, masitinib (AB1010) can be considered as a good candidate at the dose of 3 and 4.5 mg/kg/day.
Sponsor: AB Science

Current Primary Outcome:

• 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)

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: AB Science

Dates:
Date Received: June 5, 2013
Date Started: January 2012
Date Completion: December 2016
Last Updated: June 6, 2013
Last Verified: June 2013