The effectiveness and safety of Kami Guibi-tang for mild cognitive impairment: study protocol of a pilot, randomized,

Hee-Yeon Shin1,2, Jeong-Hwa Kim1,2, Geon-Ho Jahng3

  • 1Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.

Trials
|July 24, 2019
PubMed
Abstract

Insights

This study investigates Kami Guibi-tang (KGT) as a potential treatment for amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer's disease. The randomized trial will assess KGT's effectiveness and safety over 24 weeks.

Area of Science:

  • Neurology
  • Pharmacology
  • Gerontology

Background:

  • Mild cognitive impairment (MCI) represents a transitional stage between normal aging and dementia.
  • Amnestic MCI (aMCI) is a significant prodromal stage for Alzheimer's disease (AD), making it a critical target for intervention.
  • Currently, no approved treatments exist for MCI, highlighting the need for novel therapeutic strategies.

Purpose of the Study:

  • To evaluate the efficacy and safety of Kami Guibi-tang (KGT), a traditional Korean herbal medicine, in patients with amnestic MCI.
  • To determine if KGT can improve cognitive function and alter brain metrics in individuals with aMCI.
  • To provide foundational data for future large-scale clinical trials investigating KGT for MCI treatment.

Main Methods:

  • A single-center, randomized, placebo-controlled, double-blind trial design.
  • Participants with amnestic MCI will receive either KGT or a placebo for 24 weeks.
  • Primary outcomes include changes in neuropsychological test scores (Seoul Neuropsychological Screening Battery) and MRI measurements (brain metabolites, neurotransmitters, cerebral blood flow).

Main Results:

  • The study is designed to collect data on the primary and secondary outcomes.
  • Safety will be assessed through blood chemistry and AD-related protein/cholesterol levels.
  • MRI changes will be analyzed, accounting for age and genetic factors.

Conclusions:

  • This trial represents the first clinical investigation into the therapeutic potential of Kami Guibi-tang for amnestic MCI.
  • The findings are expected to inform the design and feasibility of larger studies to establish KGT as a viable treatment option for MCI.

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