Masitinib in Patients With Mild to Moderate Alzheimer's Disease

Launched by AB SCIENCE · Sep 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called masitinib for people with mild to moderate Alzheimer's disease. Researchers want to see how well masitinib works when added to other treatments that help with Alzheimer's symptoms, specifically cholinesterase inhibitors (like donepezil) and memantine. The trial is currently not yet recruiting participants, but it aims to include adults aged 18 and older who have been diagnosed with Alzheimer's disease using specific guidelines and tests.

To be eligible for this trial, participants should have mild to moderate Alzheimer's, shown by a score on a mental assessment test, and they must have been on stable doses of certain Alzheimer's medications for at least six months. It's also important that they don't have other conditions that could cause dementia. If chosen to participate, individuals can expect to take masitinib alongside their current Alzheimer's medications and will be monitored throughout the study. This trial offers a chance to contribute to research that could help improve treatment options for Alzheimer's disease.

Gender

ALL

Eligibility criteria

• Main inclusion criteria include:
• • Patient with clinical diagnosis of Alzheimer's disease based on the International Working Group criteria according to the European Guideline on the clinical investigation of medicines for the treatment of Alzheimer's disease (CPMP/EWP/553/95 Rev.2 - 2018) at screening visit
• • Patient with MMSE ≥ 14 and ≤ 25 at screening visit and baseline visit
• • Patient with Alzheimer's disease biomarker profile at screening visit
• • Patients treated for a minimum of 6 months with a stable dose of cholinesterase inhibitors (donepezil, rivastigmine or galantamine) at baseline visit, and/or a stable dose of memantine for a minimum of 6 months at baseline visit, with no changes foreseen in therapy throughout the study
• • If receiving a supplement for cognition (eg, gingko biloba, omega-3 polyunsaturated fatty acid, vitamin E, curcumin, souvenaid) must be taking a stable dose for at least 4 months prior to screening visit
• Main exclusion criteria include:
• • Patients with any other cause of dementia shown by MRI findings and neurological examination in the last 12 months prior to screening visit
• • Systemic conditions known to cause dementia, e.g., hypothyroidism, untreated vitamin B12 or folic acid deficiency, niacin deficiency, neurosyphilis, HIV infection at screening visit
• • Patients with substance-induced dementia at screening visit
• • Patients with Alzheimer's disease with delirium at screening visit
• • Patients with severe forms of delusions (e.g, NPI-12 delusion score of 4 or more) at screening visit
• • Patients with evidence of psychosis and/or use of antipsychotic drugs at screening, or history of significant psychiatric disorder at screening visit