ClinicalTrials.gov
ClinicalTrials.gov Menu

Masitinib in Patients With Mild to Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01872598
Recruitment Status : Active, not recruiting
First Posted : June 7, 2013
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
AB Science

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Masitinib Drug: Placebo Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 721 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2012
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Masitinib
Other Name: AB1010

Experimental: Masitinib fixed dose (4.5 mg/kg/day)
Participants receive masitinib at 4.5 mg/kg/day, given orally twice daily.
Drug: Masitinib
Other Name: AB1010

Experimental: Masitinib fixed dose (3.0 mg/kg/day)
Participants receive masitinib at 3.0 mg/kg/day, given orally twice daily.
Drug: Masitinib
Other Name: AB1010

Placebo Comparator: Placebo (escalating dose)
Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment
Drug: Placebo
Other Name: Placebo Oral Tablet

Placebo Comparator: Placebo (fixed dose)
Participants receive fixed dose placebo, given orally twice daily
Drug: Placebo
Other Name: Placebo Oral Tablet




Primary Outcome Measures :
  1. ADCS-ADL [ Time Frame: 24 weeks ]
    Change in the Alzheimer's Disease Cooperative Study Activities of Daily Living score (ADCS-ADL).

  2. ADAS-Cog [ Time Frame: 24 weeks ]
    Change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog).


Secondary Outcome Measures :
  1. MMSE [ Time Frame: 24 weeks ]
    Change in Mini Mental State Examination (MMSE)

  2. CIBIC-plus [ Time Frame: 24 weeks ]
    Clinician's Interview Based Impression of Change-plus (CIBIC-plus)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


Locations
Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
AB Science
Investigators
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: December 5, 2018
Last Verified: December 2018

Keywords provided by AB Science:
Alzheimer
dementia
cognitive disease
memory loss
cerebrovascular disease
tyrosine kinase inhibitor

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders