Effects of Kami Guibi-tang in patients with mild cognitive impairment: study protocol for a phase III, randomized, double-blind, and placebo-controlled trial

被引：1

作者：

Shin, Hee-Yeon ^{[1
,2
]}

Yim, Tae-Bin ^{[2
,3
]}

Heo, Hye-Min ^{[2
,3
]}

Jahng, Geon-Ho ^{[4
]}

Kwon, Seungwon ^{[5
]}

Cho, Seung-Yeon ^{[3
,5
]}

Park, Seong-Uk ^{[3
,5
]}

Jung, Woo-Sang ^{[5
]}

Moon, Sang-Kwan ^{[5
]}

Ko, Chang-Nam ^{[3
,5
]}

Park, Jung-Mi ^{[3
,5
]}

机构：

[1] CHA Univ, Korean Med Ctr, Dept Internal Korean Med, Bundang Med Ctr, 59 Yatap Ro, Seongnam Si 13496, Gyeonggi Do, South Korea

[2] Kyung Hee Univ, Grad Sch, Dept Clin Korean Med, 26 Kyungheedae Ro, Seoul 02447, South Korea

[3] Kyung Hee Univ Hosp Gangdong, Stroke & Neurol Disorders Ctr, 892 Dongnam Ro, Seoul 05278, South Korea

[4] Kyung Hee Univ, Kyung Hee Univ Hosp Gangdong, Coll Med, Dept Radiol, 892 Dongnam Ro, Seoul 05278, South Korea

[5] Kyung Hee Univ, Coll Korean Med, Dept Cardiol & Neurol, 26 Kyungheedae Ro, Seoul 02447, South Korea

来源：

BMC COMPLEMENTARY MEDICINE AND THERAPIES | 2022年 / 22卷 / 01期

关键词：

Mild cognitive impairment (MCI); Amnestic mild cognitive impairment (aMCI); Kami Guibi-tang; Herbal medicine; Herbal formula; Korean medicine; Neuropsychological test; Functional magnetic resonance imaging (fMRI); PLASMA AMYLOID-BETA; MINI-MENTAL-STATE; ALZHEIMERS-DISEASE; DEMENTIA; MEDICINE; MEMORY;

D O I：

10.1186/s12906-022-03805-9

中图分类号：

R [医药、卫生];

学科分类号：

10 ;

摘要：

BackgroundAmnestic mild cognitive impairment (aMCI) is often considered a precursor to Alzheimer's disease (AD) and represents a key therapeutic target for early intervention of AD. However, no treatments have been approved for MCI at present. Our previous pilot study has shown that Kami Guibi-tang (KGT), a traditional herbal prescription widely used in Korean medicine for treating amnesia, might be beneficial for improving general cognitive function of aMCI patients. We will conduct a larger-scale clinical trial to validate the findings of our pilot study and further examine the efficacy and safety of KGT in aMCI.MethodsThis trial is designed as a randomized, double-blind, placebo-controlled clinical trial. A total of 84 aMCI patients will be recruited and randomized into the treatment and control groups. Participants will be administered either KGT or placebo granules for 24 weeks, with a follow-up period of 12 weeks after the last treatment. Primary outcomes will include changes in cognitive performance assessed using a neuropsychological test battery, called the Seoul Neuropsychological Screening Battery, between the baseline, post-intervention visit, and follow-up visit (24th and 36th week, respectively). Secondary outcomes will involve the rate of progression to AD, changes in neuroimaging signals assessed using structural magnetic resonance imaging (MRI), resting-state functional MRI (rs-fMRI), and task-based fMRI, and changes in blood biomarkers measured by the ratio of plasma amyloid-beta 42/40 levels (A beta 42/A beta 40) between the baseline and post-intervention visit (24th week). For safety assessments, blood chemistry tests and electrocardiograms (ECG) will also be performed.DiscussionThis study aims to provide confirmatory evidence of the effect of the Korean herbal medicine, KGT, on improving cognitive function in patients with aMCI. We will identify the possible mechanisms underlying the effects of KGT using neuroimaging signals and blood biomarkers.

引用

页数：10