A Phase 2 interventional study of MLC901 and Placebo in Cognitive Impairment, sponsored by National University Hospital, Singapore. Completed at 5 sites in 3 countries. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-07-27.
Sponsored by National University Hospital, Singapore · Phase 2, Interventional, and Treatment
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.
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
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 103 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Brand: Neuroaid II. Dosage: 2 capsules 3 times a a day
Drug: MLC901
MLC901 matching placebo made by the same manufacturer for this study dosage: 2 capsules 3 times a day.
Drug: Placebo
24 weeks intervention with orally MLC901. 2 capsules 3 times a day
Also known as: NeuroaidII (MLC901)
24 weeks intervention with orally placebo. 2 capsules 3 times a day
Also known as: MLC901 matched Placebo
Comparative change on executive function
To evaluate the comparative change from baseline with MLC901 and placebo on executive function in patients with cognitive impairment not dementia due to cerebrovascular disease, as measured by: Verbal Fluency and Colour Trails Test 1 \& 2
Time frame: Baseline to 24th week(24 week)
Comparative change on cognitive function
To evaluate the comparative change from baseline with Neuroaid and placebo on cognitive function, as measured by: ADAS-Cog MoCA Cognitive Battery (Symbol Digits Modalities Test, Maze, Digit Cancellation Test, Clock Drawing Test, Visual Memory Test and Frontal Assessment Battery)
Time frame: Baseline to 24th week(24 week)
Effects on activities of daily living
To evaluate the effects of Neuroaid on activities of daily living by : Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale for mild cognitive impairment (MCI)
Time frame: Baseline to 24th week(24 week)
Effects on behaviour
To evaluate the effects of Neuroaid on behaviour by : Neuropsychiatric Inventory (NPI)
Time frame: Baseline to 24th week(24 week)
Effects on depression
To evaluate the effects of Neuroaid on depression by : Geriatric Depression Scale (GDS)
Time frame: 24 week
Adverse events, laboratory tests, and vital signs.
To evaluate the safety and tolerability of ML901 for 24 weeks of treatment, in comparison with placebo. Safety will be assessed using adverse events, laboratory tests, and vital signs.
Time frame: Baseline to 24th week(24 week)
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National University Hospital, Singapore