Masitinib in Patients With Mild to Moderate Alzheimer's Disease

Sponsor
AB Science
Study ID
NCT01872598
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Masitinib — DRUG
  • Placebo — DRUG
  • Standard of care — DRUG
    stable dose of cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine, as per standard practice.

Study Details

The purpose of this study is to assess the safety and efficacy of masitinib for the treatment of mild to moderate Alzheimer's Disease. Masitinib will be administered as add-on therapy in patients who have been treated for a minimum of 6 months with a stable dose of cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine.

Key Dates

Start date
Jan 31, 2012
Status verified
Sep 2023
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
721 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Masitinib escalating 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
  • Experimental: Masitinib fixed dose (4.5 mg/kg/day)
    Participants receive masitinib at 4.5 mg/kg/day, given orally twice daily.
  • Experimental: Masitinib fixed dose (3.0 mg/kg/day)
    Participants receive masitinib at 3.0 mg/kg/day, given orally twice daily.
  • Placebo Comparator: Placebo (escalating dose)
    Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment
  • Placebo Comparator: Placebo (fixed dose)
    Participants receive fixed dose placebo, given orally twice daily

Primary Outcome Measure

ADCS-ADL [ Time Frame: 24 weeks ]

Related Studies