A Long-term Study of NeuroAid (MLC601, MLC901) in Patients with Alzheimer's Disease; An Extension 8-year Follow-up Study.

Abstract

Background: MLC601 and MLC901 showed neuroprotective and neuroregenerative properties and positive results in the treatment of dementia and cognitive impairment. This study aimed to investigate the long-term benefits of monotherapy with MLC601 and MLC901 in patients with Alzheimer's disease (AD).

Methods: In this study, patients with AD, diagnosed by DSM-IV criteria, were enrolled. Patients have received MLC601 for four years, and their regimen has changed to MLC901 for another four years. Recruited patients were followed to assess the efficacy and safety first of MLC601 and MLC901. Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) were used to assess cognitive function. Safety was evaluated by monitoring adverse events (AEs) and abnormal findings in physical examinations or lab tests.

Results: At the end of the trial, the changes in the mean (±SD) MMSE and ADAS-Cog scores were 5.1 (3.09) and 12.5 (10.89), respectively. Both scores showed a significant change in repeated measure analysis, with the ADAS-Cog score indicating a higher change than the MMSE score (P < 0.001).

Conclusion: For more than eight years, we studied monotherapy with NeuroAid (MLC601, MLC901) in patients with AD. The study contributes further to the long-term safety and efficacy data of MLC in patients with AD.