NCT01847924

NEURoaid II (MLC 901) Assessment in Cognitively Impaired Not Demented Subjects

NEURoaid II (MLC 901) Assessment in Cognitively Impaired Not Demented Subjects : a Pilot Double Blind, Placebo-controlled Randomized Trial on Efficacy and Safety (NEURITES) Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Patients who have suffered from stroke may develop problems with thinking. Moreover, such patients have a high risk of becoming demented, more dependent or dying. Therefore, further studies are urgently needed to find effective and safe treatments. Neuroaid is a Traditional Chinese Medicine which has been shown to stimulate growth of brain cells and connections in animals. Neuroaid may improve blood flow in the brain and functional recovery after stroke in patients. Neuroaid-II is a simplified formula with only the main 9 herbal ingredients of the original formula and no animal ingredients. The NEURoaid II (MLC 901) assessment in cognitively Impaired not demented subjects: a pilot double blind, placebo-controlled randomized Trial on Efficacy and Safety (NEURITES) Study is a 24-week, early phase trial of Neuroaid-II in patients who have thinking problems after stroke. The study aims to investigate the effectiveness of the study drug in improving cognitive performance. The safety of the study drug will be closely monitored using adverse events, laboratory tests and vital signs. The trial is important as it aims to set new standards for the scientific evaluation of Asian Traditional Medicine for integration into standard medicine practice. It may potentially establish a novel therapeutic approach for improving cognition after stroke.

Detailed description

A substantial proportion of patients after non-disabling stroke are cognitively impaired compared to aged and education matched community dwelling controls. Moreover, post-stroke patients who have vascular cognitive impairment not dementia (VCIND) of moderate severity have a high risk of incident dementia, dependency and death. Further studies are urgently needed to demonstrate effective cognition enhancing therapies in VCIND given the absence of evidence based treatment options. Neuroaid is a Traditional Chinese Medicine which has been shown to induce neurogenesis, promote cell proliferation and stimulate development of axonal and dendritic networks in animal models. Neuroaid may improve functional recovery after stroke in patients. Neuroaid-II is a simplified formulation with only 9 herbal and no animal ingredients. The NEURoaid II (MLC 901) assessment in cognitively Impaired not demented subjects: a pilot double blind, placebo-controlled randomized Trial on Efficacy and Safety (NEURITES) Study is a 24-week Phase II study. The primary outcome is executive function as measured by the Verbal Fluency test. Secondary outcomes include cognitive measures such as the ADAS-Cog, MoCA, MMSE and a Cognitive Battery; Activities of Daily Living as measured by the ADCS-ADL scale; behaviour as measured by the Neuropsychiatric Inventory and depression as measured by the Geriatric Depression Scale and Beck Depression Scale. Safety and tolerability will be assessed using adverse events, laboratory tests, and vital signs. The trial is important for translational medicine in Singapore through setting new standards for systematic evaluation of Traditional Medicine for integration into standard medicine practice

Conditions

• Cognitive Impairment

Interventions

Type	Name	Description
DRUG	MLC901	24 weeks intervention with orally MLC901. 2 capsules 3 times a day
DRUG	Placebo	24 weeks intervention with orally placebo. 2 capsules 3 times a day

Timeline

• Start date: 2013-03-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2013-05-07
• Last updated: 2018-07-27

Locations

5 sites across 3 countries: Philippines, Singapore, Vietnam