NEURoaid II (MLC 901) Assessment in Cognitively Impaired Not Demented Subjects
Condition: Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

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
    

Intervention name(s): MLC901; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 24 weeks intervention with orally MLC901. 2 capsules 3 times a day; 24 weeks intervention with orally placebo. 2 capsules 3 times a day
Other intervention name(s): NeuroaidII (MLC901); MLC901 matched Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment