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.

BACKGROUND:
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.

METHODS:
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.

RESULTS:
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.

CONCLUSIONS:
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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