Clinical Data

        Effects on functional outcome in non-acute and late stage post-stroke patient:
 
NeuroAiD was registered by the Sino FDA in 2001 after being evaluated in two randomized double-blind positive-controlled clinical trials. The results of these trials were published in 2009 and included 605 patients recruited within 2 weeks to 6 months post-stroke from six hospitals between December 1999 and July 2000. NeuroAiD was compared to Buchang Naoxintong Jiaonang, then leading traditional Chinese medicine (TCM) prescribed for stroke recovery by doctors in China, as an ethical way of studying the effects of NeuroAiD.
 
Subjects were treated for 1 month. Inclusion criteria were: 1) patients with recent ischemic stroke (from 15 days to 6 months), 2) patients satisfying Western diagnostic standards for stroke and TCM standards for diagnosis of apoplexy, and 3) a severity score excluding very mild stroke or a Diagnostic Therapeutic Effects of Apoplexy (DTER ) score ≥ 10.
 
The functional outcome, measured by the Comprehensive Function Score component of the DTER scale(akin to a modified Rankin Score) showed a statistically significant superiority of NeuroAiD over the positive control treatment group (RR = 2.4, 95% CI= 1.28, 4.51; p=.007). Furthermore subjects showed on average an increase of 25% in the recovery of the motor functions in the NeuroAiD group as compared with the control group. Tolerance was excellent in both groups.
 
The figures below demonstrate the benefit of NeuroAiD in improving functional outcome and reducing neurological deficits in post stroke patients. The effect of NeuroAiD on other functions such as language, visual symptoms and facial paralysis was less significant.
 
       Neuroaid acting as a booster of stroke recovery
 
A pilot study on 40 patients with ischemic stroke within 1 month of onset and treated with either NeuroAiD or placebo for 1 month showed encouraging positive trends on motor recovery and a tendency for increased benefits towards recovery over time in enhancing the potential for motor recovery.
 
The results of the pilot study was later confirmed by a larger study on 150 patients (100 on NeuroAiD and 50 on placebo) with ischemic stroke within 1 month of ischemic stroke. Patients were treated for 3 months and assessed with the same motor scale (Fugl Meyer assessment scale) as the pilot study every month for 3 months. This study showed that the motor recovery of patients on NeuroAiD was significantly much more than patients on placebo, and this difference was seen as early as 4 weeks from start of treatment and persists up to 3 months.
       Effects of NeuroAiD on cerebral blood flow velocity and visual cortex neuroplasticity
 
 












 
In a study of 80 patients who had ischemic stroke within a week and treated with NeuroAiD or placebo for 3 months, the investigators found a better improvement in the middle cerebral artery flow velocity in those treated with NeuroAiD as compared to the placebo group, and was associated with a better functional score for activities of daily living (Barthel Index).
 
In another study of 40 patients with pure homonymous hemianopsia from PCA infarction within one week of onset and treated with either NeuroAiD or piracetam for 3 months, it was shown that patients on NeuroAiD gained back more of their visual field at 3 months compared to control in absolute terms. This study is yet among the strong clinical clues of neuroplasticity and how NeuroAiD may enhance such processes after the damaging effect of stroke.
 
Data on cortical functions recovery
 
A case series published in European Neurology reported 10 cases of patients, from Mount Alvernia Hospital in Singapore, who received 2 to 3 months treatment of NeuroAiD after a stroke. Treatment was initiated between one week and six months post-stroke and given as an add-on medication.
The cases were a mixture of anterior and posterior circulation infarction with motor, sensory, balance, vision, and/or speech deficits. All cases reported improvements: 6 cases of full recovery, 2 cases of good recovery, 1 case of moderate recovery and 1 case of only minor recovery. Significant improvements were recorded in speech and visual functions, aside from motor and balance. Remarkably, three patients who started NeuroAiD treatment at a later stage of stroke recovery (i.e. 1 to 6 months after the stroke and recovery has reached a plateau) experienced significantly recovery.
 
Other case series and reports
 
A number of case studies and series have reported the use of NeuroAiD in neurosurgical pathologies (ICH, TBI, AVM). Other reports have also shown the tendencies towards better recovery of overall function, and/or motor, gait, vision, and speech functions. These have been presented in posters in international conferences and are available upon request atmedical@moleac.net.
 
Further clinical research
 
The CHIMES trial (www.chimes-society.org) is a double-blind randomized placebo-controlled academic trial aimed at evaluating the efficacy and safety of NeuroAiD (MLC601) in ischemic patients receiving three month treatments regimen initiated within 72 hours after stroke. This study recruited1100 patients. 
 
 
- CHIMES Society, a unique international partnership of experts in strokes undertakes first large-scale endeavour to investigate the use of a treatment derived from natural substances in stroke management

-  Rigorous study shows ischemic stroke patients of intermediate severity who take NeuroAiD at acute stage had an 11 % increase in the odds of achieving independence and being able to perform daily activities at the end of three months

-  Effect was even greater when NeuroAiD was started beyond 48 hours after stroke onset, with an increase of 39%.



       Safety Data
 
A substudy in CHIMES (see above) evaluated the safety of NeuroAiD in patients with acute stroke treated for three months in a randomized placebo-controlled trial. A total of 114 patients were included and assessed on biochemical, haematological and electrocardiographic test parameters. The study showed no difference in side effects and test parameters between the NeuroAiD and placebo treatment among acute stroke patients receiving a three-month treatment.
In an earlier safety study conducted under the supervision of Professor Marie Germaine BOUSSER (Hôpital Lariboisière - France), it was shown that NeuroAiD, given alone or co-administered with aspirin had no unexpected effects on coagulation factors, specifically on Quick Prothrombin time, Activated partial prothrombin time, Fibrinogen, D-Dimer test, and platelet aggregation.
NeuroAiD also had no effect on blood pressure and does not significantly affect hematological, hemostatic, and biochemical parameters, in normal and stroke patients when started and maintained at the early stage of acute stroke
In addition, all the published studies on the efficacy of NeuroAiD similarly demonstrated the remarkable safety of NeuroAiD with no related serious or severe side effects reported.

 

       Pharmacology of NeuroAiD
 
NeuroAiD has been shown to stimulate the expression of Brain Derived Neurotrophic Factor (BDNF), which plays a role in preventing neuronal death and promoting neurogenesis. NeuroAiD’s neurogenic effect was demonstrated on in vitro neuronal and human stem cells cultures. NeuroAiD was shown to increase differentiation of neuronal stem cells and promote neurite outgrowth and connectivity.
 
In animal models NeuroAiD treatment drastically improved neurological deficit and was associated with reduced infarct volume. The neuroprotective properties of NeuroAiD were shown in both vitro and in vivo animal models as enhanced cell survival, reduced glutamate-induced cell death, and reduced lipid peroxidation/oxidative stress, aside from the increased expression of BDNF. It also appears that protein kinase Akt mediates the beneficial effects of NeuroAiD