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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.
Background:
Mild cognitive impairment (MCI) is an intermediate phase between normal aging and dementia. Since a majority of amnestic MCI (aMCI) cases progress to Alzheimer's disease (AD), it is considered the prodromal stage of AD and, therefore, a treatment target for the prevention of further cognitive decline. However, there is no approved treatment for MCI at present. Kami Guibi-tang (KGT) is a herbal drug used in Korean medicine to treat amnesia, insomnia, loss of appetite, and depression. We will explore the effectiveness and safety of KGT in amnestic MCI in this trial.
Methods/Design:
The study will be a single-center, randomized, placebo-controlled, double-blind trial. Eligible participants diagnosed with amnestic MCI will be randomly allocated to a treatment or control group. Participants will take KGT or placebo granules, three times a day, for 24 weeks. The primary outcomes will be changes in Seoul Neuropsychological Screening Battery (SNSB) scores, and magnetic resonance imaging (MRI) measurements including those of brain metabolites, neurotransmitters, and cerebral blood flow. The secondary outcomes will include the safety assessment, measured by changes in blood chemistry, changes in blood protein and cholesterol levels related to AD pathology, and a comparison of MRI changes between the two groups, using age and genotype as covariates.
Discussion:
This study will be the first clinical trial to identify the therapeutic potential of Kami Guibi-tang for amnestic MCI. The findings will provide insight into the feasibility of large-scale trials to gather evidence for KGT as a treatment for MCI.
Trial Registration:
Korean Clinical Trial Registry, ID: KCT0002407 . Registered on 30 March 2017.
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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