Safety and Use of MLC601/MLC901 (NeuroAiDTM) in Primary Intracerebral Hemorrhage: A Cohort Study from the NeuroAiD Safe Treatment Registry

Abstract

Background: MLC601/MLC901 (NeuroAiD™) is a combination of natural products shown to be safe and to aid neurological recovery after brain injuries, especially ischemic stroke. Few studies have investigated NeuroAiD in primary intracerebral hemorrhage (ICH). The NeuroAiD Safe Treatment (NeST) Registry explores NeuroAiD use in the real-world setting. This cohort study aimed to assess its use and safety in ICH. Methods: The online NeST Registry of subjects with ICH given NeuroAiD prospectively collected clinical data at baseline and monthly visits (V) 1 to 3. Outcome measures included compliance, side effects, Glasgow Coma Scale (GCS), National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), and Short Orientation-Memory-Concentration Test (SOMCT). Results: Sixty-six subjects were included. NeuroAiD was well-tolerated with fair compliance over three months. Two non-serious side effects were reported. Mean scores significantly improved on all outcome scales. The proportion of subjects with favorable outcomes significantly improved from baseline to V3: NIHSS 0–4, from 12% to 59% (p < 0.0001); GCS 13–15, from 64% to 88% (p = 0.007); mRS 0–1, from 9% to 37% (p = 0.004); and SOMCT score 0–8, from 44% to 68% (p = 0.029). Conclusions: NeuroAiD in the real-world setting was safe and showed potential for a sustained positive effect on neurological recovery after ICH.

A systematic-search-and-review of registered pharmacological therapies investigated to improve neuro-recovery after a stroke

“…A long-term follow-up study of patients with ischemic stroke ( n = 880) showed that the odds ratio (OR) of functional independence was significantly increased at 6 months (1.49, 95% CI 1.11–2.01) and persisted up to 18 months (OR 1.36, 95% CI 1.01–1.83) on mRS and at 6 months (OR 1.55, 95% CI 1.14–2.10) on BI after treatment with MLC601 compared to placebo (LOE B-R) ( 25 ). One cohort study ( n = 66) was the only paper available in patients with ICH ( 26 ). While patients treated with MLC601/MLC901 showed a sustained effect on neurological and functional recovery, this was not a controlled study.…”

Loganin exerts neuroprotective effect by inhibiting neuronal pyroptosis in rat with cerebral haemorrhage

“…Similarly, the knockout of MLCK210, another key protein in these pathways, has been shown to prevent cerebral microhemorrhages and reduce neuroinflammation in vascular cognitive impairment and dementia, emphasizing the importance of these pathways in neuroprotection 23 . Additionally, the safety and efficacy of MLC601/MLC901 (NeuroAiD) in treating primary ICH have been validated, indicating well‐tolerated use and potential sustained positive impacts on neurological recovery 24 . Therefore, loganin's modulation appears to stabilize the post‐ICH intracellular environment, reducing microglial overactivation and subsequent pro‐inflammatory cytokine production and mitigating neuronal death.…”

“…23 Additionally, the safety and efficacy of MLC601/MLC901 (NeuroAiD) in treating primary ICH have been validated, indicating well-tolerated use and potential sustained positive impacts on neurological recovery. 24 Therefore, loganin's modulation appears to stabilize the post-ICH intracellular environment, reducing microglial overactivation and subsequent pro-inflammatory cytokine production and mitigating neuronal death. Loganin's suppression of pro-inflammatory cytokines, such as IL-1β and tumour necrosis factor (TNF)-α, suggests a shift toward a neurosupportive microglial phenotype.…”

What can traditional Chinese medicine do for adult neurogenesis?

“…There are only a few clinical reports on the toxicity and adverse effects of TCMs regulating adult neurogenesis, whether used alone or in combination. The side effects of TCMs, including MLC901 ( Kumar et al, 2020 ), curcumin ( Asher and Spelman, 2013 ; Fan et al, 2013 ), and Polygala tenuifolia ( Zhao X. et al, 2020 ), are largely gastrointestinal, such as nausea, vomiting, and diarrhea. The majority of side effects are mild and temporary, and after discontinuing the medication, these symptoms will gradually subside.…”