Research Reports - MLC901 (NeuroAiD II™ ) for cognition after traumatic brain injury

Eur J Neurol. 2018 Apr 3. doi: 10.1111/ene.13653

Theadom A1, Barker-Collo S2, Jones KM1, Parmar P1, Bhattacharjee R1, Feigin VL1.

Treatments to facilitate recovery after traumatic brain injury (TBI) are urgently needed. To examine the safety and potential effects of herbal supplement MLC901 (NeuroAiD IITM ) on cognitive functioning following TBI, we conducted a nine-month pilot, randomised placebo-controlled clinical trial.

Adults aged 18-65 years, 1-12-months post-mild or moderate TBI, were randomised to receive MLC901 (0.8g capsules/day) or placebo for 6-months. The primary outcome was cognitive functioning assessed by the CNS-Vital Signs online neuropsychological test. Secondary outcomes included Cognitive Failures Rivermead Post-Concussion Symptoms (neurobehavioral sequelae), Quality of Life after Brain Injury, Hospital Anxiety and Depression Scale, Fatigue Impact Scale and Glasgow Outcome Scale-Extended (physical disability). Assessments were completed at baseline and 3, 6, 9-month follow-up. Linear mixed effects models were conducted, with the primary outcome time-point of 6-months.

Seventy-eight participants (mean age 37.5±14.8, 39 (50%) female) were included in the analysis. Baseline variables were comparable between groups (treatment group n=36, control group n=42). Linear mixed effects models controlling for time, group allocation, repeated measurements, adherence and baseline assessment scores, revealed significant improvements in complex attention (p=0.04, d=0.6) and executive functioning (p=0.04, d=0.4) at 6-months in the MLC901 group compared to controls. There were no significant differences between the groups for neurobehavioral sequelae, mood, fatigue, physical disability or overall quality of life at 6-months. No serious adverse events were reported.

MLC901 is safe and well tolerated post-TBI. This study provides Class I/II evidence that for patients with mild to moderate traumatic brain injury, 6-months of MLC901 improves cognitive functioning. 

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