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Publications
 
 I. Non-Clinical Studies
 
 
Neuroprotective and neuroproliferative activities of NeuroAiD™ (MLC601, MLC901), a Chinese medicine, in vitro and in vivo. Neuropharmacology. 2010
 
The published results describe a significant neuroprotective effect of NeuroAiD™ against an ischemic insult when given prior and/or after injury. It shows that NeuroAiD™ supports neuroplasticity, increases neurogenesis, increases neurites outgrowth and synaptogenesis, provides a better environment for post stroke recovery and decreases neurological impairments.
 
 
 
MLC901, a traditional Chinese medicine protects the brain against global ischemia. Neuropharmacology. 2011
 
The results of this clinical study led on rodents describe a significant neuroprotective effect of MLC901 on hippocampal CA1 region against global ischemia. It shows that thanks to Akt protein, MLC901 prevents necrosis and apoptotic cell death induced by global ischemia, enhances neurogenesis and improves functional recovery. Thus, MLC901 could be a novel therapeutic strategy in treating not only cognitive and motor deficits caused by global ischemia, but also neurological deficits caused by cardiac arrest and other situations that deprive brain of oxygen and glucose.
 
Click hereto access abstract on Pubmed


Activation of ATP-sensitive potassium channels as an element of the neuroprotective effects of the Traditional Chinese Medicine MLC901 against oxygen glucose depriviation. Neuropharmacology 2012.

This paper highlights the potency of NeuroAid in neuroprotection with the discovery of a key underlying mechanism of action.The activation by NeuroAid ot the ATP-sensitive potassium channel located in the suffering neurons of the brain protects them from death.Indeed, the opening of the channel decreases the excitabty of neurons (by hyperpolarization) preventing an overload of calcium and release of excitotoxic glutamate.Besides the beneficial effects in neuroplasticity already published, these results strengthen the interest of NeuroAid in stroke recovery.

http://www.ncbi.nlm.nih.gov/pubmed/22659084


NeuroAid : properties for Neuroprotection and neurorepair (Heurteaux, Widmann et. al) Cerebrovascular Dseases March 2013

This paper reviews the pharmacological effects of NeuroAid on noraml ans ischemic brain and neurons.In vivo and in Vitro experiments using mouse model of stroke (focal ischemia), rat model of cardiac arrest(global ischemia0 and cortical neurons in culture were reviews and summarized.In conclusion NeuroAid demonstrated both neuroprotective and neurogenerative properties.


http://www.ncbi.nlm.nih.gov/pubmed/23548913        
 

 II. Ischemic Stroke
 
 
Chinese Medicine NeuroAid Efficacy on Stroke Recovery:A Double-Blind, Placebo -Controlled Randomized Study.Stroke  2013.

The CHIMES study is an academic interantional double-blind placebo-controlled clinical trail which treated and monitored 1100 patients from several countries who had suffered an ischemic stroke of intermediate severity within 72 hours. The research concluded that NeuroAid is statistically no better than placebo in improving outcomed at 3 monts when used among patients with acute ischmic stroke of intermediate severity. However the results of the study confirmed the overall benefit of neuroAid in stroke recovery and Showed that treatment effect for achieving functional independence was greater among non-acute strokes, consistent with previous studies.In addition the study showed that NeuroAid had an excellent safety profile. 

http://www.ncbi.nlm.nih.gov/pubmed/23780952







NeuroAiD™ (Danqi Piantan Jiaonang), a traditional Chinese medicine, in post stroke recovery. Stroke. 2009
 
This reports deals with clinical trials led on 605 patients recruited between 2 weeks and 6 months after their stroke (initial stroke trials in China). The results show that patients on NeuroAiD™ have 2.4 times more chances to achieve independence after 1 month of treatment, and have a 25% higher recovery in the motor impairments.
 
 
 
Safety and efficacy of MLC601 in Iranian patients after stroke: a double-blind, placebo-controlled clinical trial. Stroke Research and Treatment. 2011
 
This study, led on 150 Iranian patients with a recent ischemic stroke, shows that MLC601 not only improves motor recovery, but also is safe on top of standard ischemic stroke medication especially in severe and moderate cases. In fact, patients who received MLC601 showed significantly better motor recovery than placebo group after 4, 8 and 12 weeks. The improvement was mostly manifested after first month and developed more during 12 weeks. Moreover, good tolerability to treatment was shown and adverse events were mild and transient.
 
 
 
The effect of NeuroAiD™ (MLC601) on cerebral blood flow velocity in subjects' post brain infarct in the middle cerebral artery territory.European Journal of Internal Medicine. 2011
 
This double-blind placebo-controlled randomized study was led on 80 patients. Among them, 40 received 4 capsules of NeuroAiD™ 3 times a day for 3 months and 40 others received placebo. The subjects were recruited at Ahvaz Golestan Hospital in Iran from April 2009 to March 2010. This study shows that MLC601 increases cerebral blood flow velocity in post brain infarct subjects. Results show that the increase in cerebral blood flow velocity is significantly higher in MLC601 group than in control group. Eventually, patients cured with MLC601 recorded a significant improvement in their daily activities.
 
 
 
A double-blind, placebo-controlled, randomized phase II pilot study to investigate the potential efficacy of the traditional Chinese medicine NeuroAiD (MLC601) in enhancing recovery after stroke (TIERS). Cerebrovascular Diseases 2009.
 
The aim of this phase II double-blind placebo controlled study was to investigate the efficacy of NeuroAiD on motor recovery in ischemic stroke patients using rehabilitation endpoints in order to provide predictive information for further larger trials. In this clinical trial, 20 patients within 1 month post-stroke received 4 capsules of NeuroAiD 3 times a day for 4 weeks and 20 other patients received placebo. While no statistical significance was detected for all primary and secondary endpoints due to the small sample size, subgroup analysis show trends for better outcome with NeurAiD for more severe strokes, posterior strokes, and strokes with potential for recovery at 8 weeks.
 
 
 
NeuroAiD (MLC601) versus piracetam in the recovery of post-infarct homonymous hemianopsia. Neural Regeneration Research 2011.
 
In the clinic, the natural recovery rate of homonymous hemianopsia caused by occipital lobe infarction is low. This prospective study compared the effects of NeuroAiD (MLC 601) versus piracetam in improving visual field defects in 40 patients matched for age and sex within 1 week of PCA infarction with pure homonymous hemianopsia. After 3 months of treatment, the findings suggest that MLC601 is superior to piracetam for reducing quantitative visual field defects in homonymous hemianopsia patients.
 
 
 
NeuroAiD in Stroke Recovery. European Neurology 2008.
 
This case series report deals with 10 patients who received NeuroAiD after an ischemic stroke as confirmed on brain imaging (MRI). Conducted in an outpatient private clinic in Mount Alvernia Hospital in Singapore, the report suggests that NeuroAiD can be considered as an add-on treatment to other medications including anti-platelet, warfarin, lipid-lowering, anti-hypertensive, anti-diabetic, and antidepressant medications.
Click here to access the Publication

Efficacy and Safety of MLC601 (NeuroAID), a Traditional Chinese Medicine, in Postroke Recovery: A Systematic Review. Cerebrovascular Diseases March 2013.

This publication updates the 2-study meta-analysis published in Stroke journal in 2009 with all clinical data available since on NeuroAiD and provides an overall assessment of the effects of NeuroAiD in improving functional and motor outcomes by the end of treatment. In a systematic review this paper shows that previous studies on NeuroAiD in ischemic stroke in general were of low risk of bias. The meta-analysis showed a statistically significant beneficial effect in favor of NeuroAiD on functional outcome when assessed at the end of study treatment. Although the results did not reach statistical significance, the overall effects on motor recovery were also in favor of
NeuroAiD.
http://www.ncbi.nlm.nih.gov/pubmed/23548914

 
The use of NeuroAiD (MLC601) in Post ischemic Patients.
Rehabilitation Research and Practice 2012.


This paper aimed to assess the efficacy of MLC601 on functional recovery in patients given MLC601 after an ischemic stroke. This was a retrospective cohort study comparing 30 post-stroke patients given open-label MLC601 for three months and 30 matching patients who did not receive MLC601 from the Stroke Data Bank. There were positive results from this study: NeuroAiD has been shown to improve functional recovery at 3 months post-ischemic stroke.
http://www.ncbi.nlm.nih.gov/pubmed/23304514
 

 III. Hemorrhagic Stroke and Traumatic Brain Injury
 
 
Case report on the use of MLC601 (NeuroAiD) in neurosurgical pathologies. Poster WSC Seoul. 2010.
 
This case series report of 20 patients treated with MLC601 in the Neurosurgery division of National University Hospital in Singapore. All patients received 4 capsules of MLC601 3 times a day for 3 months started within 3 months of onset of brain injury or stroke. All patients reported some improvements and good tolerance for the drug. Three cases (head injury, hemorrhagic stroke from AVM, and brain abscess) with remarkable outcomes were presented, illustrating how it may not be unreasonable to prescribe MLC601 to selected patients with difficult neurosurgical pathology in the hope that the neurological function outcome would improve.
 
 

 IV. Safety
 
 
Safety Profile of MLC601 (NeuroAiD) in acute ischemic stroke patients: a Singaporean substudy of the Chinese medicine NeuroAiD efficacy on stroke recovery study. Cerebrovascular Diseases 2010.
 
This study on 114 patients with acute ischemic stroke randomized within 48 hours of onset shows that serious adverse events (SAEs) were similar between the group treated with placebo and the group treated with MLC601. The SAEs reported were those commonly seen in stroke patients. There were neither statistically or clinically significant differences between treatment groups in biochemical, haematological, or electrocardiogram tests at 3 months, nor any statistically or clinically significant differences in the absolute and relative changes of the various parameters between baseline and 3 months. Thus, MLC601 is safe for patients with acute stroke receiving a 3-month treatment.
 
 
 
NeuroAiD does not modify hemostasis, hematology, and biochemistry in normal subjects and stroke patients. Cerebrovascular Diseases 2008.
 
NeuroAiD does not significantly affect hematological, hemostatic, and biochemical parameters in normal and stroke patients. Clinical parameters and expected effects of aspirin are not altered by co-administration of the drug even when started and maintained at the early stage of acute stroke.
 
 

 V. Clinical Trial
 
A double-blind, placebo-controlled, randomized, multicenter study to investigate Chinese medicine NeuroAiD efficacy on stroke recovery (CHIMES Study). International Journal of Stroke 2009.
 
NeuroAiD does not significantly affect hematological, hemostatic, and biochemical parameters in normal and stroke patients. Clinical parameters and expected effects of aspirin are not altered by co-administration of the drug even when started and maintained at the early stage of acute stroke.

Click here to access abstract on Pubmed
 
Chinese Medicine NeuroAiD Efficacy Stroke Recovery – Extension Study (CHIMES-E Study):
An Observational Multicenter Study to Investigate the Longer-Term Efficacy of NeuroAiD in Stroke Recovery. Cerebrovascular Diseases March 2013

This extension study tests the hypothesis that at 2 years, an initial 3-month administration of NeuroAiD is superior to placebo in reducing neurological deficit and improving functional outcome in patients with cerebral infarction of an intermediate range of severity. Study subjects are those who are already participants in CHIMES study – aged about 21 years and had signs and symptoms of acute stroke, 6 ≤ NIHSS ≤ 14, neuroimaging consistent with ischemic stroke and received study
medication with 72 hours of stroke onset. In conclusion this study will provide evidence for the longterm efficacy of an initial course of a neurorestorative therapy with NeuroAiD after acute ischemic stroke of intermediate severity.
http://www.ncbi.nlm.nih.gov/pubmed/?term=extension+study+(chimes-E+Study)

The NeuroAiD II (MLC901) in Vascular Cognitive Impairment Study (NEURITES) (C.Chen, K Ikram et. al). Cerebrovascular Diseases March 2013

The objective of this study is to investigate the effects and tolerability of NeuroAiD II in patients with VCIND (Vascular Cognitive Impairment no Dementia). The NeuroAiD II (MLC901) in Vascular Cognitive Impairment Study (NEURITES) is a 24-week, double-blind, randomized, placebocontrolled phase II study of NeuroAiD II in patients with VCIND. In conclusion NEURITES has the potential to set new standards for the systematic evaluation of Asian traditional medicine for integration into standard medicine practice and establishing a novel therapeutic approach for improving cognition after stroke.
http://www.ncbi.nlm.nih.gov/pubmed/?term=neuroaid+in+vascular+cognitive
 
                                      
        VI:  Alzheimer 's Disease
                                     

                                     

                                          NeuroAiD (MLC601) and Amyloid Precursor Protein Processing. 
                                      
Cerebrovascular Diseases March 2013
                                      

                                     The purpose of this paper was to investigate the effects of MLC601 (NeuroAiD) on regulation
                                     of
APP (Amyloid Precursor Protein) processing. Human neuroblastoma cell line SH-SY5Y was
                                     used
for all experiments. Cells were treated with different concentration of NeuroAiD before
                                     assessing
changes in the levels of released lactate dehydrogenase (LDH), full-length APP and
                                   
 sAPPα. In conclusion it appears that NeuroAiD is a possible modulator of APP processing and
                                     has i
mplications as a putative therapeutic strategy for the treatment of post stroke dementia
                                     and AD.

                                     The purpose of this paper was to investigate the effects of MLC601 (NeuroAiD) on regulation
                                     of
APP (Amyloid Precursor Protein) processing. Human neuroblastoma cell line SH-SY5Y was
                                     used f
or all experiments. Cells were treated with different concentration of NeuroAiD before
                                     assessing
changes in the levels of released lactate dehydrogenase (LDH), full-length APP and
                                     secreted
APPα. In conclusion it appears that NeuroAiD is a possible modulator of APP
                                     processing and has i
mplications as a putative therapeutic strategy for the treatment of post
                                     stroke dementia and AD.

                                     http://www.ncbi.nlm.nih.gov/pubmed/?term=neuroaid+and+amyloid

                                     Efficacy and Tolerability of MLC601 in Patients with Mild to Moderate Alzheimer Disease
                                     Who
Were Unable to Tolerate or Failed to Benefit from Treatment with Rivastig Harandi,
                                     Ashrafi e
t. al). British Journal of Medicine & Medical Research February
                               2013

                                         The aim of this early stage “proof-of-concept” clinical study was to evaluate the efficacy and
                                      tolerability of MLC601 in patients with mild to moderate Alzheimer disease (AD). The results
                                      showed
 that NeuroAiD was well-tolerated even up to 18 months of treatment. This tolerability
                                      represents
key improvement compared to current AD treatments, i.e. ChEIs, in which modest
                                      but significant
therapeutic effect is often compromised by the occurrence of adverse events
                                      and discontinuation
of treatment.




                      
 
   
 

 
 
 


 
 
 
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