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Masitinib in Patients With Mild to Moderate Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT01872598
Recruitment Status : Active, not recruiting
First Posted : June 7, 2013
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
AB Science

June 5, 2013
June 7, 2013
December 10, 2018
January 2012
April 2019   (Final data collection date for primary outcome measure)
  • ADCS-ADL [ Time Frame: 24 weeks ]
    Change in the Alzheimer's Disease Cooperative Study Activities of Daily Living score (ADCS-ADL).
  • ADAS-Cog [ Time Frame: 24 weeks ]
    Change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog).
  • 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)
Complete list of historical versions of study NCT01872598 on ClinicalTrials.gov Archive Site
  • MMSE [ Time Frame: 24 weeks ]
    Change in Mini Mental State Examination (MMSE)
  • CIBIC-plus [ Time Frame: 24 weeks ]
    Clinician's Interview Based Impression of Change-plus (CIBIC-plus)
Not Provided
Not Provided
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Masitinib in Patients With Mild to Moderate Alzheimer's Disease
A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Phase 3 Study to Evaluate the Safety and Efficacy of Masitinib in Patients With Mild to Moderate Alzheimer's Disease
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.
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. Masitinib is a selective tyrosine kinase inhibitor that is thought to exert a neuroprotective effect through its activity on mast cells and other non-neuronal cells of the central nervous system, with subsequent modulation of inflammatory and neurodegenerative processes, as well as possibly disruption of the Aβ signaling cascade via inhibition of the Fyn signaling pathway. This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study of oral masitinib. The objective of this study is to compare the efficacy and safety of masitinib at various doses versus matched placebo in the treatment of patients with 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. Approximately 675 patients will be randomized into 5 treatment groups. The co-primary outcome measures are the Alzheimer's Disease Cooperative Study Activities of Daily Living score (ADCS-ADL), and Alzheimer's Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog) after 24 weeks of treatment.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer Disease
  • Drug: Masitinib
    Other Name: AB1010
  • Drug: Placebo
    Other Name: Placebo Oral Tablet
  • 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
    Intervention: Drug: Masitinib
  • Experimental: Masitinib fixed dose (4.5 mg/kg/day)
    Participants receive masitinib at 4.5 mg/kg/day, given orally twice daily.
    Intervention: Drug: Masitinib
  • Experimental: Masitinib fixed dose (3.0 mg/kg/day)
    Participants receive masitinib at 3.0 mg/kg/day, given orally twice daily.
    Intervention: Drug: Masitinib
  • Placebo Comparator: Placebo (escalating dose)
    Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo (fixed dose)
    Participants receive fixed dose placebo, given orally twice daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
721
396
October 2019
April 2019   (Final data collection date for primary outcome measure)

Inclusion criteria include:

  1. Patient with dementia of Alzheimer's type, according to the Diagnostic and Statistical Manual of Mental Disorders criteria (DSM-IV)
  2. 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)
  3. Patient with MMSE ≥ 12 and ≤ 25 at baseline
  4. 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:

  1. Patient with any other cause of dementia not due to Alzheimer's disease.
  2. 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).
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01872598
AB09004
Yes
Not Provided
Not Provided
AB Science
AB Science
Not Provided
Principal Investigator: Bruno DUBOIS, M.D., Ph.D. Pitié-Salpétrière
AB Science
December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP