An investigator-initiated randomized, double-blind, placebo-controlled trial (ongoing)

To participate, visit ClinicalTrials.gov for registration!

Sponsor: National University Hospital

Research Aims

The aims of this study are to determine the safety and efficacy of Neuroaid II (MLC901), in combination with standard treatment (cholinesterase inhibitors or memantine), in patients with mild to moderate Alzheimer’s disease. NeuroAid is a mixture of nine herbal substances used in traditional Chinese medicine. To determine the efficacy of NeuroAid, the investigators are evaluating its effect on cognitive function and disease progression in these patients.

How the Core Is Integral to the Study

  • Coordinated site start-up
  • Recruited and retained subjects (>100 patients recruited, with a retention rate of 98%)
  • Obtained regulatory and safety approvals: included obtaining the necessary regulatory approvals from the Health Sciences Authority (HSA), such as the clinical trial certificate, as well as ethics and safety committee (DSRB) approvals
  • Performed the following cognitive assessments to help determine efficacy of NeuroAid for cognitive function:
    • Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-COG)
    • Mini Mental State Examination (MMSE)
  • Performed the following assessments to help determine efficacy of NeuroAid for slowing AD disease progression:
    • Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (ADCS-CGIC)
    • Neuropsychiatric Inventory (NPI)
    • Alzheimer’s Disease Co-operative Study – Activities of Daily Living (ADCS-ADL)
    • ADAS-COG
    • MMSE
  • Trained raters for the above assessments
  • Data management, including development of study database and data monitoring (filling in missing data; editing incorrect data)

Results

Since this trial is still ongoing, outcomes have not been reported yet. Watch this space for updates!

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