The Neuroaid Ii (Mlc901) in Vascular Cognitive Impairment Study (Neurites) : Preliminary Results

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January 1, 2017

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Narayanaswamy Venketasubramanian, « The Neuroaid Ii (Mlc901) in Vascular Cognitive Impairment Study (Neurites) : Preliminary Results », Open Research Library, ID : 10.26226/morressier.5cb58cedc668520010b56204


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Background and Aims: NEURITES is a 24-week, multi-center, double-blind, randomized, placebo-controlled phase II study of NeuroAiD II in patients with vascular cognitive impairment not demented (CIND). The primary objective was to evaluate the comparative change from baseline with MLC901 and placebo on executive function in VCIND patients as measured by Verbal Fluency (VF) and Color Trails Test (CTT) 1 & 2. The trial is registered as Clinicaltrials.gov-NCT01847924.Methods: Inclusion criteria: Male and female subjects were eligible if they fulfilled the following inclusion criteria: age 55-85 years, Modified Rankin Score u22643 (mRS), diagnosis of CIND due to cerebrovascular disease, cognitive impairment documented by neuropsychological evaluation within 12 months of index stroke/Transient Ischemic attack, not demented by DSM-IV criteria. MLC901 or matching placebo was administered for 24 weeks along with standard post-stroke care. Primary Analysisu2022 VF, individual scores for Animals / Food and sum of scores (mean and SD), analyzed at week 12 and 24 u2022CTT, mean and SD of completion time of CTT-1 and CTT-2 in seconds , analyzed at week 12 and 24. u2022Change (mean and SD) from baseline at 12 and 24 weeks between MLC901 and Placebo treated groups. Post hoc Subgroup analysis -To test the hypothesis that Neuroaid would show a larger effect in patients with impairments in baseline scores, stratified by education level, for VF using the validated Vascular Dementia battery 1 or scoring below the 5th percentile (adjusted for age and education) for CTT2.Results: NEURITES randomized 103 subjects: placebo (n=46) and MLC901 (n=57) with a mean age of 68.3 u00b1 8.4 years; 38.8% of whom were female. At week 12, statistical significance was observed with CTT-2 (change of score from baseline of -1.8u00b122.3 Vs -12.7u00b132.3, P=0.05) between MLC901 and Placebo but there was no statistically significant difference at Week 24. There was no significant difference in VF or the CTT-1. There were 13(22.8%) Serious Adverse Events (SAEs) with one possibly related in the MLC901 group compared to 6 (13%) in the placebo group. The difference did not reach statistical significance (P=0.30). A larger effect size in favour of MLC901 was seen among subjects impaired at baseline, both at 12 and 24 weeks with statistically significant CTT-2 changes at 12 weeks (-4.7u00b116.2 vs -19.1u00b132.4, P=0.05).Conclusions: MLC901 demonstrated safety and early improvement in cognitive outcomes as compared to placebo. Subjects with impaired baseline executive function tended to show better improvement with MLC901. These results would help to characterize the type of patients to be included in future clinical trials. Ref: 1. Yeo D, Gabriel C, Chen C, Lee S, Loenneker T, Wong M. Pilot validation of a customized neuropsychological battery in elderly Singaporeans. Neurol J South East Asia. 1997; 2:123.2. Du2019Elia, L. F., Satz, P., Uchiyama, C. L., & White, T. (1994). Color Trails Test (CTT). USA: Psychological Assessment Resources, Inc.

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