KGT improved learning performance in a mouse model of accelerated senescence, and reduced spatial memory impairment induced by scopolamine or delta-tetrahydrocannabinol. Several studies have explored the effects of KGT on cognitive impairment, particularly in AD. Kami Guibi-tang (KGT) is a popular herbal medicine used in Korean and Kampo medicine to treat amnesia, insomnia, loss of appetite, and depression. There is, however, no treatment approved for enhancing memory function, or preventing further cognitive decline in MCI. Early treatment of mild-to-moderate AD is associated with better responses than later treatment, so treatment of MCI may delay progression to AD. A previous study revealed that 16% of amnestic MCI (aMCI) patients progress to dementia each year, 99% of whom receive an AD diagnosis. In particular, the amnestic subtype of MCI, which manifests as memory complaints, is often caused by degenerative etiologies and is generally regarded as a precursor of AD. The majority of people with MCI develop dementia due to Alzheimer’s disease (AD). This clinical condition is characterized by self or caregiver-reported memory or cognitive complaints, and objective cognitive impairment, that is not severe enough to interfere with daily activities. Mild cognitive impairment (MCI) is an intermediate phase between normal aging and dementia. Korean Clinical Trial Registry, ID: KCT0002407. The findings will provide insight into the feasibility of large-scale trials to gather evidence for KGT as a treatment for MCI. This study will be the first clinical trial to identify the therapeutic potential of Kami Guibi-tang for amnestic MCI. 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. 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. Participants will take KGT or placebo granules, three times a day, for 24 weeks. Eligible participants diagnosed with amnestic MCI will be randomly allocated to a treatment or control group. The study will be a single-center, randomized, placebo-controlled, double-blind trial. We will explore the effectiveness and safety of KGT in amnestic MCI in this trial. Kami Guibi-tang (KGT) is a herbal drug used in Korean medicine to treat amnesia, insomnia, loss of appetite, and depression. However, there is no approved treatment for MCI at present. 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.
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