Status:
COMPLETED
Masitinib in Patients With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
AB Science
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 ...
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 (memantin...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
721 Patients enrolled
Trial Details
Trial ID
NCT01872598
Start Date
January 1 2012
End Date
December 1 2020
Last Update
September 29 2023
Active Locations (6)
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1
MHAT Sveta Marina
Varna, Bulgaria, 9010
2
General Hospital of Thessaloniki
Thessaloniki, Greece, 570 10
3
Centrum Zdrowia Stołeczna 7
Bialystok, Poland, 15-879
4
Spitalul Universitar de Urgenta Elias
Bucharest, Romania, 013686