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SoUth Korean study to PrEvent cognitive impaiRment and protect BRAIN health through Multidomain interventions via facE-to-facE and video communication plaTforms in mild cognitive impairment (SUPERBRAIN-MEET): Protocol for a Multicenter Randomized Controlled Trial.
Cho, SH, Kang, HJ, Park, YK, Moon, SY, Hong, CH, Na, HR, Song, HS, Choi, M, Jeong, S, Park, KW, et al
Dementia and neurocognitive disorders. 2024;(1):30-43
Abstract
BACKGROUND AND PURPOSE The SoUth Korea study to PrEvent cognitive impaiRment and protect BRAIN health through lifestyle intervention (SUPERBRAIN) proved the feasibility of multidomain intervention for elderly people. One-quarter of the Korean population over 65 years of age has mild cognitive impairment (MCI). Digital health interventions may be cost-effective and have fewer spatial constraints. We aim to examine the efficacy of a multidomain intervention through both face-to-face interactions and video communication platforms using a tablet personal computer (PC) application in MCI. METHODS Three hundred participants aged 60-85 years, with MCI and at least one modifiable dementia risk factor, will be recruited from 17 centers and randomly assigned in a 1:1 ratio to the multidomain intervention and the waiting-list control groups. Participants will receive the 24-week intervention through the tablet PC SUPERBRAIN application, which encompasses the following five elements: managing metabolic and vascular risk factors, cognitive training, physical exercise, nutritional guidance, and boosting motivation. Participants will attend the interventions at a facility every 1-2 weeks. They will also engage in one or two self-administered cognitive training sessions utilizing the tablet PC application at home each week. They will participate in twice or thrice weekly online exercise sessions at home via the ZOOM platform. The primary outcome will be the change in the total scale index score of the Repeatable Battery for the Assessment of Neuropsychological Status from baseline to study end. CONCLUSIONS This study will inform the effectiveness of a comprehensive multidomain intervention utilizing digital technologies in MCI. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT05023057.
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Effects of the multidomain intervention with nutritional supplements on cognition and gut microbiome in early symptomatic Alzheimer's disease: a randomized controlled trial.
Lee, EH, Kim, GH, Park, HK, Kang, HJ, Park, YK, Lee, HA, Hong, CH, Moon, SY, Kang, W, Oh, HS, et al
Frontiers in aging neuroscience. 2023;:1266955
Abstract
BACKGROUND The SoUth Korean study to PrEvent cognitive impaiRment and protect BRAIN health through lifestyle intervention in at-risk elderly people (SUPERBRAIN) is a part of the World-Wide Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (WW-FINGERS) network. This study aimed to demonstrate the effects of the SUPERBRAIN-based multidomain intervention with nutritional supplements in amyloid positive emission tomography (PET) proven early symptomatic Alzheimer's disease patients. METHODS Forty-six participants who were diagnosed with mild cognitive impairment or mild dementia and were positive in the amyloid PET study randomized into three groups: group A, the multidomain intervention with nutritional supplements; group B, nutritional supplements only; and a control group. The primary outcome was a change in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total scale index score after an 8-week intervention. Secondary outcomes, including gut microbiome data, were also analyzed. RESULTS The RBANS total scale index score improved significantly in group A compared with group B (p < 0.032) and compared with the control group (p < 0.001). After intervention, beta diversity of the gut microbiome between group A and the control group increased, and patients in group A were more enriched with Bifidobacterium. CONCLUSION SUPERBRAIN-based multidomain intervention with nutritional supplements improves cognition and gut microbiota in patients with early symptomatic Alzheimer's disease who were amyloid-positive by PET.
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Effect of preoperative eyedrops on cytokine concentrations in aqueous humor of patients undergoing femtosecond laser-assisted cataract surgery.
Lee, JH, Chung, HS, Moon, SY, Yoon, J, Lee, K, Lee, H, Kim, JY, Lim, HT, Tchah, H
Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie. 2022;(3):885-891
Abstract
PURPOSE To compare the anti-inflammatory activity of preoperatively applied eyedrops, as determined by cytokine concentrations in aqueous humor collected during surgery in patients undergoing femtosecond laser-assisted cataract surgery. METHODS A total of 120 patients undergoing femtosecond laser-assisted cataract surgery were randomly assigned to four groups of 30 patients each. Groups were administered 0.1% fluorometholone eyedrops, 0.45% ketorolac tromethamine eyedrops, both 0.1% fluorometholone and 0.45% ketorolac tromethamine eyedrops, or no eyedrops. Eyedrops were instilled 1 h, 20 min, and just before surgery. After anterior capsulotomy and nuclear fragmentation using a femtosecond laser, 0.1 cc aqueous humor was obtained using a needle and syringe. Cytokine and prostaglandin E2 (PGE2) concentrations were quantitatively determined. RESULTS The 120 patients included 59 men and 61 women, of mean age 65.02 years. The mean interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) concentrations after treatment did not differ significantly in the four groups. The average interleukin-8 (IL-8) concentrations were significantly lower in the fluorometholone (4.80 pg/mL), ketorolac tromethamine (4.84 pg/mL), and fluorometholone + ketorolac tromethamine (4.68 pg/mL) groups than in the control group (6.83 pg/mL). Furthermore, the average PGE2 concentrations were significantly lower in the ketorolac tromethamine (270.04 pg/mL) and fluorometholone + ketorolac tromethamine (239.00 pg/mL) groups, but not in the fluorometholone (393.16 pg/mL) group, than in the control group (472.36 pg/mL). CONCLUSION Preoperative fluorometholone instillation reduced IL-8, and ketorolac tromethamine instillation reduced IL-8 and PGE2, in aqueous humor of patients undergoing femtosecond laser surgery, with the combination of both eyedrops being more effective than either alone. TRIAL REGISTRATION KCT0005717.
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The effectiveness of a motivational enhancement smartphone application promoting lifestyle improvement for brain health: A randomized controlled trial.
Roh, HW, Ryu, H, Jeong, S, Han, J, Park, B, Moon, SY, Choi, SH, Son, SJ, Hong, CH
PloS one. 2022;(6):e0267806
Abstract
Multidomain lifestyle modification is considered an effective intervention for dementia prevention due to its multifactorial nature. Recognizing that participants' activity adherence is crucial for successful lifestyle modification, our team developed a smartphone application to enhance motivation toward brain health behavior based on gamification theory, which influences behaviors by enhancing motivation. The developed smartphone application has two main functions: delivering supporting videos from family, friends, and medical staff, and self-evaluation. We assessed the effectiveness of this smartphone application with regard to brain health behavior. In this eight-week randomized controlled trial, 40 participants were randomly assigned to the smartphone application intervention group or control group. The primary outcome reflected participants' brain health behavior in three categories: physical activity, cognitive activity, and healthy diet. Each brain health behavior was measured by the Korean version of the Global Physical Activity Questionnaire, Cognitive Activity Score, and Mediterranean DASH Intervention for Neurodegenerative Delay Diet Score. Furthermore, we investigated the change in motivation, measured by the Situational Motivation Scale. Additionally, we reviewed participants' self-record diary during the first, fourth, and eighth week of intervention for evaluation of adherence. The intervention group was found to have a positive association with moderate metabolic equivalent activities (P = 0.01) and intrinsic motivation change (P = 0.01). There was a significant difference between the intervention and control groups regarding average physical activity at week 8 (P = 0.037). An eight-week intervention with the smartphone application induced physical activity of moderate intensity through intrinsic motivation enhancement. We suggest that the motivation enhancement application could be an efficient option for maintaining and promoting psychosocial health behavior. This smartphone application can be applied to any other disease that needs behavioral change. Through the application, a broader spectrum of the population, regardless of time, space, and human resources, can benefit from community health services. Trial registration: Korean National Clinical Trial Registry CRIS identifier: KCT0005231.
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIb Clinical Study to Evaluate the Safety and Efficacy of DHP1401 in Patients with Mild to Moderate Alzheimer's Disease Treated with Donepezil: DHP1401 Randomized Trial in Mild to Moderate Alzheimer's Disease (DRAMA).
Shim, Y, Han, HJ, Park, KW, Kim, BC, Park, KH, Park, MY, Kim, HJ, Moon, SY, Choi, SH, Park, KW, et al
Journal of Alzheimer's disease : JAD. 2022;(1):391-403
Abstract
BACKGROUND Preclinical studies in transgenic models of Alzheimer's disease (AD) suggest that DHP1401 has neuroprotective and memory-enhancing effects. OBJECTIVE To evaluate the efficacy and safety of DHP1401 in AD patients treated with donepezilMethods:Methods: In a double-blind study, patients with mild-to-moderate AD were randomized (1:1:1) to receive a twice daily total dose of 500 mg or 1000 mg DHP1401 or placebo for 24 weeks. Tolerability and safety were monitored at baseline and weeks 12 and 24. RESULTS total of 180 patients were randomized to Active 1 (500 mg: n = 62), Active 2 (1000 mg: n = 53), and control groups (n = 65) in 16 sites in Korea. There was no significant difference in the Alzheimer's Disease Assessment Scale (ADAS-cog) score, the primary efficacy endpoint, from baseline. However, in the subgroup with mild AD patients (MMSE, 20-26) who received the high dose of DHP1401 and the group that received donepezil 5 mg, the ADAS-cog scores improved. MMSE and K-TMT-e type B were significant in both active groups at week 24. The most frequently observed symptom was dizziness (2.78%), and the most commonly observed reactions were related to metabolism and nutrition disorders (5.00%). No remarkable adverse events were observed for 24 weeks. CONCLUSION Although the effectiveness of DHP1401 was not proved to be superior as the primary efficacy endpoint, the secondary endpoints, MMSE and K-TMT-e type B, showed significant beneficial effects. Also, the subgroups showed that ADAS-cog scores significantly were improved. DHP1401 could be proven beneficial for the AD treatment by further clinical trials.
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Expanding Indications for a Ketogenic Diet as an Adjuvant Therapy in Adult Refractory Status Epilepticus: an Exploratory Study Using Moderation Analysis.
Koh, S, Kim, TJ, Shin, HB, Kim, HK, Park, B, Moon, SY, Kim, BG, Huh, K, Choi, JY
Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics. 2022;(5):1526-1534
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Abstract
Refractory status epilepticus (RSE) requires multimodal treatment approaches to achieve rapid seizure cessation and neuroprotection. A ketogenic diet (KD) has demonstrated efficacy as a nutritional therapeutic option for adult RSE. However, the group of adult RSE patients who would benefit from adopting a KD needs to be determined to appropriately select the patients indicated for a KD. Therefore, we conducted a nonrandomized retrospective cohort study to explore the therapeutic efficacy of a KD by investigating the moderation effect of a KD on the association between the clinical characteristics of RSE patients and their functional outcomes. This study investigated 140 RSE patients, including 32 patients treated with a KD; among these patients, 28 (81%) achieved seizure cessation. We found that KD moderated the reduction in the modified Rankin scale (mRS) score at discharge among patients who were older, had higher seizure severity scores, were under continuous intravenous anesthetic therapy (CIVAD), and had super-RSE. Age and seizure severity scores, but not CIVAD or super-RSE, were associated with a KD-moderated change in mRS score at 3 months. Thus, we consider that our study provides evidence of a neuroprotective effect of KD in the most severe RSE patients with very few remaining therapeutic options, but future randomized controlled trials in these subgroups of KD patients are necessary.
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Impact of Multidomain Lifestyle Intervention on Cerebral Cortical Thickness and Serum Brain-Derived Neurotrophic Factor: the SUPERBRAIN Exploratory Sub-study.
Moon, SY, Kim, S, Choi, SH, Hong, CH, Park, YK, Na, HR, Song, HS, Park, HK, Choi, M, Lee, SM, et al
Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics. 2022;(5):1514-1525
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In the SoUth Korean study to PrEvent cognitive impaiRment and protect BRAIN health through lifestyle intervention in at-risk elderly people (SUPERBRAIN), we evaluated the impact of a 24-week facility-based multidomain intervention (FMI) and home-based MI (HMI) on cortical thickness, brain volume, and the serum brain-derived neurotrophic factor (BDNF). Totally, 152 participants, aged 60-79 years without dementia but with ≥ 1 modifiable dementia risk factor, were randomly assigned to the FMI, HMI, or control groups. Among them, 55 participants (20 FMI, 19 HMI, and 16 controls) underwent brain MRI at baseline and 24 weeks. We compared changes in global/regional mean cortical thickness at the region-of-interest (ROI) between the intervention and control groups. The changes in the total cortical gray matter volume and global mean cortical thickness were compared using analysis of covariance with age, sex, and education as covariates. ComBat site harmonization was applied for cortical thickness values across the scanners. ROI-based analysis was controlled for multiple comparisons, with a false discovery rate threshold of p < 0.05. Serum BDNF levels were significantly higher in the FMI group than in the control group (p = 0.029). Compared with the control group, the mean global cortical thickness increased in the FMI group (0.033 ± 0.070 vs. - 0.003 ± 0.040, p = 0.013); particularly, cortical thickness of the bilateral frontotemporal lobes, cingulate gyri, and insula increased. The increase in cortical thickness and serum BDNF in the FMI group suggests that group preventive strategies at the facility may be beneficial through structural neuroplastic changes in brain areas, which facilitates learning and neurotrophic factors.
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Understanding Viral Infection Mechanisms and Patient Symptoms for the Development of COVID-19 Therapeutics.
Choi, HM, Moon, SY, Yang, HI, Kim, KS
International journal of molecular sciences. 2021;22(4)
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The outbreak of a novel coronavirus was reported in Wuhan, in the Hubei province of China, in December 2019. This virus was officially designated as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) because of its phylogenetic and taxonomic similarities to other coronaviruses. The aim of this review was to understand the viral infection mechanisms of SARS-CoV-2, the clinical features of Covid-19 and the mechanisms through which Covid-19 can be effectively treated with existing drugs. Literature shows that: • SARS-CoV-2 is usually transmitted by inhalation or contact with infected droplets. Inhaled droplets or aerosol carrying the virus then infect and spread through the respiratory tracts. • Severe inflammatory response is a remarkable feature of Covid-19 symptoms. This is caused by delayed viral clearance, which induces chronic systemic inflammation and widespread tissue damage, even leading to cytokine storms. • The incubation period is generally 5-6 days, but it ranges from one day to as much as two weeks. • Interstitial pneumonia and subsequent acute respiratory distress syndrome are the leading causes of death in patients with Covid-19. • There is no licensed treatment for Covid-19, only a combination of antiviral and anti-inflammatory drug treatments are being used. Authors conclude that their finding may provide new insights into the development of therapeutics by understanding the various clinical and basic research studies currently underway.
Abstract
Coronavirus disease 2019 (COVID-19), caused by the SARS-CoV-2 virus, has become a worldwide pandemic. Symptoms range from mild fever to cough, fatigue, severe pneumonia, acute respiratory distress syndrome (ARDS), and organ failure, with a mortality rate of 2.2%. However, there are no licensed drugs or definitive treatment strategies for patients with severe COVID-19. Only antiviral or anti-inflammatory drugs are used as symptomatic treatments based on clinician experience. Basic medical researchers are also trying to develop COVID-19 therapeutics. However, there is limited systematic information about the pathogenesis of COVID-19 symptoms that cause tissue damage or death and the mechanisms by which the virus infects and replicates in cells. Here, we introduce recent knowledge of time course changes in viral titers, delayed virus clearance, and persistent systemic inflammation in patients with severe COVID-19. Based on the concept of drug reposition, we review which antiviral or anti-inflammatory drugs can effectively treat COVID-19 patients based on progressive symptoms and the mechanisms inhibiting virus infection and replication.
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Facility-based and home-based multidomain interventions including cognitive training, exercise, diet, vascular risk management, and motivation for older adults: a randomized controlled feasibility trial.
Moon, SY, Hong, CH, Jeong, JH, Park, YK, Na, HR, Song, HS, Kim, BC, Park, KW, Park, HK, Choi, M, et al
Aging. 2021;(12):15898-15916
Abstract
We aimed to evaluate the feasibility of multidomain intervention (MI) tailored to the Korean context. In an outcome assessor-blinded, randomized controlled trial, participants without dementia and with one or more modifiable dementia risk factors, aged 60-79 years, were randomly assigned to the facility-based MI (FMI; n=51), the home-based MI (HMI; n=51), or the control group receiving general health advice (n=50). The 24-week intervention comprised vascular risk management, cognitive training, social activity, physical exercise, nutrition guidance, and motivational enhancement. The FMI participants performed all intervention programs at a facility three times a week. The HMI participants performed some programs at a facility once every 1-2 weeks and performed others at home. The primary outcome was feasibility measured through retention, adherence, and at least no differences from the control group in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). In the FMI and HMI groups, the retention rates were 88.2% and 96.1%, and adherence to the intervention was 94.5% and 96.8%, respectively. The RBANS total scale index score improved significantly in the FMI (5.46 ± 7.50, P = 0.004) and HMI (5.50 ± 8.14, P = 0.004) groups compared to the control group (-0.74 ± 11.51). The FMI and HMI are feasible and there are indicators of efficacy.
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South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention in At-Risk Elderly People: Protocol of a Multicenter, Randomized Controlled Feasibility Trial.
Park, HK, Jeong, JH, Moon, SY, Park, YK, Hong, CH, Na, HR, Song, HS, Lee, SM, Choi, M, Park, KW, et al
Journal of clinical neurology (Seoul, Korea). 2020;(2):292-303
Abstract
BACKGROUND AND PURPOSE The prevalence of dementia is increasing in South Korea. Multidomain interventions may be useful for preventing dementia. Such programs need to be disseminated to elderly Koreans throughout the country. We have developed programs of the SoUth Korean study to PrEvent cognitive impaiRment and protect BRAIN health through lifestyle intervention in at-risk elderly people (SUPERBRAIN), which consists of a facility-based multidomain intervention (FMI) program and a home-based multidomain intervention (HMI) program suitable for elderly Koreans. We aim to determine the feasibility of the SUPERBRAIN programs before a large-scale randomized controlled trial. METHODS We will recruit 150 participants among those without dementia aged 60-79 years with at least 1 modifiable dementia risk factor. They will be randomly assigned in a 1:1:1 ratio to the FMI, HMI, and the waiting-list control arm. The 6-month multidomain intervention consists of management of metabolic and vascular risk factors, cognitive training and social activity, physical exercise, nutritional guidance, and motivational enhancement programs. The primary outcomes are adherence and retention rates and changes in the total scale index score of the Repeatable Battery for the Assessment of Neuropsychological Status from baseline to the study end. The main secondary outcomes are disability, depressive symptoms, quality of life, vascular risk factors, physical performance, nutritional assessment, and motivation questionnaire. There will be an exploratory evaluation of neurotrophic, neurodegeneration, and neuroinflammation factors, microbiome, telomere length, electroencephalography, and neuroimaging measures. CONCLUSIONS The results obtained will provide information on the applicability of these multidomain intervention programs to at-risk elderly people.