Alzheimer Disease Clinical Trial
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
NCT number | NCT01872598 |
Other study ID # | AB09004 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | January 2012 |
Est. completion date | December 2020 |
Verified date | September 2023 |
Source | AB Science |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 721 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Bulgaria | MHAT Sveta Marina | Varna | |
Greece | General Hospital of Thessaloniki | Thessaloniki | |
Poland | Centrum Zdrowia Stoleczna 7 | Bialystok | |
Romania | Spitalul Universitar de Urgenta Elias | Bucuresti | |
Spain | Hospital Universitario Ramón y Cajal | Madrid | |
Ukraine | Municipal Institution Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnikov | Dnipropetrovsk |
Lead Sponsor | Collaborator |
---|---|
AB Science |
Bulgaria, Greece, Poland, Romania, Spain, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ADCS-ADL | Change in the Alzheimer's Disease Cooperative Study Activities of Daily Living score (ADCS-ADL). | 24 weeks | |
Primary | ADAS-Cog | Change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog). | 24 weeks | |
Secondary | MMSE | Change in Mini Mental State Examination (MMSE) | 24 weeks | |
Secondary | CIBIC-plus | Clinician's Interview Based Impression of Change-plus (CIBIC-plus) | 24 weeks |
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