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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 costeffective 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.
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Background@#and Purpose: Alzheimer’s disease (AD) is a neurodegenerative disease characterized by a progressive decline in cognition and performance of daily activities. Recent studies have attempted to establish the relationship between AD and sleep. It is believed that patients with AD pathology show altered sleep characteristics years before clinical symptoms appear. This study evaluated the differences in sleep characteristics between cognitively asymptomatic patients with and without some amyloid burden. @*Methods@#Sleep characteristics of 76 subjects aged 60 years or older who were diagnosed with subjective cognitive decline (SCD) but not mild cognitive impairment (MCI) or AD were measured using Fitbit ® Alta HR, a wristwatch-shaped wearable device. Amyloid deposition was evaluated using brain amyloid plaque load (BAPL) and global standardized uptake value ratio (SUVR) from fluorine-18 florbetaben positron emission tomography. Each component of measured sleep characteristics was analyzed for statistically significant differences between the amyloid-positive group and the amyloid-negative group. @*Results@#Of the 76 subjects included in this study, 49 (64.5%) were female. The average age of the subjects was 70.72±6.09 years when the study started. 15 subjects were classified as amyloid-positive based on BAPL. The average global SUVR was 1.598±0.263 in the amyloidpositive group and 1.187±0.100 in the amyloid-negative group. Time spent in slow-wave sleep (SWS) was significantly lower in the amyloid-positive group (39.4±13.1 minutes) than in the amyloid-negative group (49.5±13.1 minutes) (p=0.009). @*Conclusions@#This study showed that SWS is different between the elderly SCD population with and without amyloid positivity. How SWS affects AD pathology requires further research.
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Purpose@#Research on the relationship between diet and dementia among Koreans are lacking. This study investigated the association between dietary habits and dementia progression over 3 years in patients with Alzheimer’s disease dementia (ADD). @*Materials and Methods@#This study included 705 patients with mild-to-moderate ADD. Dietary habits were assessed using the Mini Dietary Assessment Index, comprising 10 questions. Outcome measures included the Clinical Dementia Rating scale-Sum of Boxes (CDR-SB), Seoul-Instrumental Activities of Daily Living, Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI), and neuropsychological test battery (NTB) z-scores, which were evaluated annually over 3 years. @*Results@#In Q10 (eat all food evenly without being picky), the 3-year mean differences in CDR-SB (increases in scores represent worsening) compared to the “rarely” group were -1.86 [95% confidence interval (CI)=-3.64 – -0.09, p=0.039] for the “usually” group and -2.23 (95% CI=-4.40 – -0.06, p=0.044) for the “always” group. In Q7 (add salt or soy sauce to food when eating), the 3-year mean differences in CDR-SB compared to the “always” group were -2.47 (95% CI=-4.70 – -0.24, p=0.030) for the “usually” group and -3.16 (95% CI=-5.36 – -0.96, p=0.005) for the “rarely” group. The “rarely” and “usually” groups in Q7 showed significantly less decline in NTB z-score and CGA-NPI compared to the “always” group. @*Conclusion@#Eating a balanced diet and reducing salt intake were associated with a slower decline in dementia severity, cognition, and behavioral alterations in patients with ADD.
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Background@#and Purpose Physical frailty is known to be closely associated with cognitive impairment and to be an early sign of Alzheimer’s disease. We aimed to understand the characteristics of physical frailty and define factors associated with physical frailty in subjects with subjective cognitive decline (SCD) by analyzing amyloid data. @*Methods@#We prospectively enrolled subjects with SCD from a cohort study to identify predictors for the clinical progression to mild cognitive impairment or dementia from SCD (CoSCo). All of the subjects underwent brain magnetic resonance imaging, and brain amyloid positron-emission tomography (PET) to detect amyloid beta plaques. Self-reported exhaustion, handgrip strength, and gait speed were used to measure physical frailty. @*Results@#Of 120 subjects with SCD, 26 (21.7%) were amyloid-positive in PET. Female (odds ratio [OR]=3.79, p=0.002) and amyloid-PET-positive (OR=3.80, p=0.008) subjects with SCD were at high risks of self-reported exhaustion. Amyloid PET positivity (OR=3.22, p=0.047) and high burden from periventricular white-matter hyperintensity (OR=3.34, 95% confidence interval=1.18–9.46, p=0.023) were significantly associated with a weaker handgrip. The subjects with SCD with self-reported exhaustion and weaker handgrip presented with lower cognitive performance in neuropsychological tests, especially for information processing speed and executive function. Subjects with a slower gait performed worse in visual memory function tests. @*Conclusions@#Amyloid PET positivity was associated with a higher risk of self-reported exhaustion and weaker handgrip in subjects with SCD. The subjects with SCD and physical frailty also performed worse in neuropsychological tests.
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Background@#and Purpose: The efficacy and safety of GV1001 have been demonstrated in patients with moderate-to-severe Alzheimer’s disease (AD). In this study, we aimed to further demonstrate the effectiveness of GV1001 using subscales of the Severe Impairment Battery (SIB), which is a validated measure to assess cognitive function in patients with moderate-tosevere AD. @*Methods@#We performed a post hoc analysis of data from a 6 month, multicenter, phase 2, randomized, double-blind, placebo-controlled trial with GV1001 (ClinicalTrials.gov, NCT03184467). Patients were randomized to receive either GV1001 or a placebo for 24 weeks. In the current study, nine subscales of SIB—social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction, and orientation to name— were compared between the treatment (GV1001 1.12 mg) and placebo groups at weeks 12 and 24. The safety endpoints for these patients were also determined based on adverse events. @*Results@#In addition to the considerable beneficial effect of GV1001 on the SIB total score, GV1001 1.12 mg showed the most significant effect on language function at 24 weeks compared to placebo in both the full analysis set (FAS) and per-protocol set (PPS) (p=0.017 and p=0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups. @*Conclusions@#Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.
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Background@#and Purpose: In this study we aimed to find the association between neuropsychological performance and body mass index (BMI) in patients with mild cognitive impairment (MCI). In addition, we investigated the effects of the apolipoprotein E (APOE) genotype in the relationship between the BMI and cognition in MCI. @*Methods@#We enrolled a cohort of 3,038 subjects with MCI aged 65–90 from the Clinical Research Center for Dementia of South Korea and a dementia cohort of the Ewha Womans University Mokdong Hospital. MCI patients were classified into three subgroups according to the Asian standard of BMI. We compared cognitive performances between groups by one-way analysis of variance. To investigate the effects of the APOE genotype, we used multivariate linear regression models after adjusting for possible confounders. @*Results@#Even though normal BMI groups were younger, had more females, and had less comorbidities, the higher BMI groups had better cognitive functions. Among subjects with APOE ε4 carriers, there was a positive relationship between the BMI and the memory task alone. @*Conclusions@#Our findings suggested that higher BMI in patients with MCI were associated with better cognitive performance. The effects of the APOE ε4 genotype in the associations between BMI and cognition were distinguishing. Therefore, according to physical status, APOE ε4 genotype-specific strategies in the assessments and treatments may be necessary in elderly patients with MCI.
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Purpose@#Neuroinflammation is considered an important pathway associated with several diseases that result in cognitive decline. 18F-THK5351 positron emission tomography (PET) signals might indicate the presence of neuroinflammation, as well as Alzheimer’s disease-type tau aggregates. β-amyloid (Aβ)-negative (Aβ–) amnestic mild cognitive impairment (aMCI) may be associated with non-Alzheimer’s disease pathophysiology. Accordingly, we investigated associations between 18F-THK5351 PET positivity and cognitive decline among Aβ– aMCI patients. @*Materials and Methods@#The present study included 25 amyloid PET negative aMCI patients who underwent a minimum of two follow-up neuropsychological evaluations, including clinical dementia rating-sum of boxes (CDR-SOB). The patients were classified into two groups: 18F-THK5351-positive and -negative groups. The present study used a linear mixed effects model to estimate the effects of 18F-THK5351 PET positivity on cognitive prognosis among Aβ– aMCI patients. @*Results@#Among the 25 Aβ– aMCI patients, 10 (40.0%) were 18F-THK5351 positive. The patients in the 18F-THK5351-positive group were older than those in the 18F-THK5351-negative group (77.4±2.2 years vs. 70.0±5.5 years; p<0.001). There was no difference between the two groups with regard to the proportion of apolipoprotein E ε4 carriers. Interestingly, however, the CDR-SOB scores of the 18F-THK5351-positive group deteriorated at a faster rate than those of the 18F-THK5351-negative group (B=0.003, p=0.033). @*Conclusion@#The results of the present study suggest that increased 18F-THK5351 uptake might be a useful predictor of poor prognosis among Aβ– aMCI patients, which might be associated with increased neuroinflammation (ClinicalTrials.gov NCT02656498).
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Background@#and Purpose: The Korean-Color Word Stroop Test: Color Reading (K-CWST:CR) included in the Seoul Neuropsychological Screening Battery, 2nd Edition (SNSB-II) examines inhibitory control deficit. It provides normative data for both 60- and 120-second conditions, but the validity of the 60-second condition has not yet been proven. This study examined the validity of the 60-second condition by observing concordance between the performances in cognitively normal, MCI, and mild dementia groups. @*Methods@#There were 1,336 patients performed the SNSB-II, including the K-CWST: CR.Based on the cognitive test results, activities of daily living, and clinical interview, the patients were assigned to normal cognition (n=104), MCI (n=884), or mild dementia (n=348) groups. Abnormal performance on the K-CWST: CR was operationally defined as 1SD below the normative mean. The receiver operating characteristic curve analyses were conducted to compare the discriminability between the 60- and 120-second conditions. @*Results@#The percentages of abnormal performance in the MCI group were 41.5% and 42.3%, and those in the mild dementia group were 82.7% and 82.4% for the 60- and 120-second conditions, respectively. The areas under the curve for the 60- and 120-seconds were as follows; 0.80 and 0.81 in differentiating normal from MCI; 0.95 and 0.96 in normal from mild dementia; and 0.77 and 0.77 in MCI from mild dementia. @*Conclusions@#The 60-second condition of the K-CWST showed very similar results, not statistically different from the 120-second condition. Therefore, the 60-second condition could be used interchangeably with the 120-second condition in a clinical setting.
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This study examined the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet of the Korean multi-domain dementia prevention program on the cognitive functions of the elderly with dementia risk factors. We developed the program including nutrition, exercise, cognitive training, vascular disease prevention, and motivation. One- hundred and fifty-three participants aged 60∼79 years with at least 1 dementia risk factor were randomly assigned in a 1:1:1 ratio to the facility-based intervention (FMI), home-based intervention (HMI), and the control group. The nutrition education program consisted of 10 classes over 24 weeks: the FMI received 7 group sessions and three 1:1 sessions, the HMI received 4 group sessions and three 1:1 sessions with 3 homework sessions. The Nutrition Quotient for Elderly (NQ-E) and the Mini Nutritional Assessment (MNA) were used to evaluate nutritional status. The Repeatable Battery for the Assessment Neuropsychological Status (RBANS), Korean Mini-Mental State Examination (K-MMSE), and the Cognitive Complaint Interview (CCI) were used to evaluate cognitive functions. A total of 136 people completed the program with an 11.1% dropout rate. The NQ-E (P=0.009) and RBANS (P=0.001) scores significantly increased in the FMI (N=45) and HMI (N=49) groups compared to the control group (N=42) after the study. The changes in the score of MNA and CCI did not differ significantly between groups. In conclusion, the nutritional intervention which focused on the MIND diet as a part of a multi-domain intervention program had a positive effect on the improvement of healthy eating habits and cognitive function scores in the high-risk dementia group.
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Background@#and Purpose The rate of donepezil discontinuation and the underlying reasons for discontinuation in Asian patients with Alzheimer’s disease (AD) are currently unknown. We aimed to determine the treatment discontinuation rates in AD patients who had newly been prescribed donepezil in routine clinical practice in Asia. @*Methods@#This 1-year observational study involved 38 institutions in seven Asian countries, and it evaluated 398 participants aged 50–90 years with a diagnosis of probable AD and on newly prescribed donepezil monotherapy. The primary endpoint was the rate of donepezil discontinuation over 1 year. Secondary endpoints included the reason for discontinuation,treatment duration, changes in cognitive function over the 1-year study period, and compliance as assessed using a clinician rating scale (CRS) and visual analog scale (VAS). @*Results@#Donepezil was discontinued in 83 (20.9%) patients, most commonly due to an adverse event (43.4%). The mean treatment duration was 103.67 days in patients who discontinued. Among patients whose cognitive function was assessed at baseline and 1 year, there were no significant changes in scores on the Mini-Mental State Examination, Montreal Cognitive Assessment, and Trail-Making Test–Black and White scores, whereas the Clinical Dementia Rating score increased significantly (p<0.001). Treatment compliance at 1 year was 96.8% (306/316) on the CRS and 92.6±14.1% (mean±standard deviation) on the VAS. @*Conclusions@#In patients on newly prescribed donepezil, the primary reason for discontinuation was an adverse event. Cognitive assessments revealed no significant worsening at 1 year, indicating that continuous donepezil treatment contributes to the maintenance of cognitive function.
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Background@#and Purpose: Reportedly 30–50% of patients being treated for chronic illnesses do not adhere to their medication regimen. We assessed the impact of a nurse-led education program for caregivers of Korean de novo Alzheimer’s disease patients who had newly been prescribed donepezil. @*Methods@#This multicenter study analyzed 93 participants in a caregiver education group and 92 participants in a caregiver no-education group. At every visit up to the end of the study (1 year), caregivers in the education group were given educational brochures regarding Alzheimer’s disease and the efficacy and adverse events of donepezil treatment. The primary endpoint was the discontinuation rate of donepezil treatment during the 1-year observation period. The secondary endpoints included the effect of education on compliance with donepezil treatment assessed at each visit using a clinician rating scale (CRS) and visual analog scale (VAS), and changes from baseline in cognitive assessment tests. @*Results@#The donepezil discontinuation rates at 1 year were 5.38% (5/93) and 6.52% (6/92) in the caregiver education and no-education groups, respectively (p=0.742). No significant between-group differences in donepezil compliance rates on the CRS and VAS were observed, but significant changes were observed in some cognitive tests from baseline to the end of the study. @*Conclusions@#Caregiver education had no significant effect on treatment discontinuation, but this may have been due to the low severity of cognitive impairment among the included population at baseline. In addition, the low discontinuation rates meant that no significant difference in treatment compliance was observed.
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Background@#and Purpose The rate of donepezil discontinuation and the underlying reasons for discontinuation in Asian patients with Alzheimer’s disease (AD) are currently unknown. We aimed to determine the treatment discontinuation rates in AD patients who had newly been prescribed donepezil in routine clinical practice in Asia. @*Methods@#This 1-year observational study involved 38 institutions in seven Asian countries, and it evaluated 398 participants aged 50–90 years with a diagnosis of probable AD and on newly prescribed donepezil monotherapy. The primary endpoint was the rate of donepezil discontinuation over 1 year. Secondary endpoints included the reason for discontinuation,treatment duration, changes in cognitive function over the 1-year study period, and compliance as assessed using a clinician rating scale (CRS) and visual analog scale (VAS). @*Results@#Donepezil was discontinued in 83 (20.9%) patients, most commonly due to an adverse event (43.4%). The mean treatment duration was 103.67 days in patients who discontinued. Among patients whose cognitive function was assessed at baseline and 1 year, there were no significant changes in scores on the Mini-Mental State Examination, Montreal Cognitive Assessment, and Trail-Making Test–Black and White scores, whereas the Clinical Dementia Rating score increased significantly (p<0.001). Treatment compliance at 1 year was 96.8% (306/316) on the CRS and 92.6±14.1% (mean±standard deviation) on the VAS. @*Conclusions@#In patients on newly prescribed donepezil, the primary reason for discontinuation was an adverse event. Cognitive assessments revealed no significant worsening at 1 year, indicating that continuous donepezil treatment contributes to the maintenance of cognitive function.
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Background@#and Purpose: Reportedly 30–50% of patients being treated for chronic illnesses do not adhere to their medication regimen. We assessed the impact of a nurse-led education program for caregivers of Korean de novo Alzheimer’s disease patients who had newly been prescribed donepezil. @*Methods@#This multicenter study analyzed 93 participants in a caregiver education group and 92 participants in a caregiver no-education group. At every visit up to the end of the study (1 year), caregivers in the education group were given educational brochures regarding Alzheimer’s disease and the efficacy and adverse events of donepezil treatment. The primary endpoint was the discontinuation rate of donepezil treatment during the 1-year observation period. The secondary endpoints included the effect of education on compliance with donepezil treatment assessed at each visit using a clinician rating scale (CRS) and visual analog scale (VAS), and changes from baseline in cognitive assessment tests. @*Results@#The donepezil discontinuation rates at 1 year were 5.38% (5/93) and 6.52% (6/92) in the caregiver education and no-education groups, respectively (p=0.742). No significant between-group differences in donepezil compliance rates on the CRS and VAS were observed, but significant changes were observed in some cognitive tests from baseline to the end of the study. @*Conclusions@#Caregiver education had no significant effect on treatment discontinuation, but this may have been due to the low severity of cognitive impairment among the included population at baseline. In addition, the low discontinuation rates meant that no significant difference in treatment compliance was observed.
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Background@#and Purpose: Rapid population aging and an increase in the demented elderly became major social concerns in South Korea. Environmental design is increasingly recognized as an important aid for long-term care of patients with dementia as well as pharmacotherapy. We did a pilot study to investigate the effect of the Seoul Dementia Healing Design Project In-House Design (S-DHDP-IHD) in improving the quality of life of the cognitively impaired patients and of the S-DHDP Environmental Design (S-DHDP-ED) in increasing daily outdoor activities for cognitively impaired individuals and not cognitively impaired (NCI) elderly residents. @*Methods@#We applied the S-DHDP-IHD to 2 households of patients with mild cognitive impairment (MCI) and early-stage vascular dementia (VD). We assessed the effectiveness of intervention by surveys and video recordings of daily tasks. Additionally, we applied the S-DHDP-ED to 5 community facilities and randomly selected 287 residents over 65 years old (32 dementia caregivers and 255 NCI elderly) to participate in surveys. @*Results@#S-DHDP-IHD intervention showed improved instrumental activities in MCI patient and early-stage VD patient. Also, the satisfaction with an intervened home environment was increased. Following S-DHDP-ED intervention, non-demented residents engaged in more outdoor and social activities. They were also satisfied with the function and design of the installed facilities. @*Conclusions@#S-DHDP encompassing both home and environmental improvements was effective in readapting cognitively impaired individuals and could achieve a customized, holistic approach to dementia caregiving by means of the improved design.
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Background@#and Purpose: Rapid population aging and an increase in the demented elderly became major social concerns in South Korea. Environmental design is increasingly recognized as an important aid for long-term care of patients with dementia as well as pharmacotherapy. We did a pilot study to investigate the effect of the Seoul Dementia Healing Design Project In-House Design (S-DHDP-IHD) in improving the quality of life of the cognitively impaired patients and of the S-DHDP Environmental Design (S-DHDP-ED) in increasing daily outdoor activities for cognitively impaired individuals and not cognitively impaired (NCI) elderly residents. @*Methods@#We applied the S-DHDP-IHD to 2 households of patients with mild cognitive impairment (MCI) and early-stage vascular dementia (VD). We assessed the effectiveness of intervention by surveys and video recordings of daily tasks. Additionally, we applied the S-DHDP-ED to 5 community facilities and randomly selected 287 residents over 65 years old (32 dementia caregivers and 255 NCI elderly) to participate in surveys. @*Results@#S-DHDP-IHD intervention showed improved instrumental activities in MCI patient and early-stage VD patient. Also, the satisfaction with an intervened home environment was increased. Following S-DHDP-ED intervention, non-demented residents engaged in more outdoor and social activities. They were also satisfied with the function and design of the installed facilities. @*Conclusions@#S-DHDP encompassing both home and environmental improvements was effective in readapting cognitively impaired individuals and could achieve a customized, holistic approach to dementia caregiving by means of the improved design.
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At the request of the authors, the NRF-support number in ‘Acknowledgements’ is modified.
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BACKGROUND@#AND PURPOSE: We aimed to determine the reliability and validity of a short form of the Korean Dementia Screening Questionnaire-Cognition (KDSQ-C) as a screening tool for cognitive dysfunction.@*METHODS@#This study recruited 420 patients older than 65 years and their informants from 11 hospitals, and categorized the patients into normal cognition, mild cognitive impairment, and dementia subgroups. The KDSQ-C was completed separately by the patients and their informants. We abstracted three components of the KDSQ-C and combined these components into the following four subscales: KDSQ-C-I (items 1–5, memory domain), KDSQ-C-II (items 1–5 & 11–15, memory domain+activities of daily living), KDSQ-C-III (items 1–5 & 6–10, memory domain+other cognitive domains), and KDSQ-C-IV (items 6–10 & 11–15, other cognitive domains+activities of daily living). The reliability and validity were compared between these four subscales.@*RESULTS@#A receiver operating characteristic (ROC) analysis of questionnaire scores provided by the patients showed that the areas under the ROC curves (AUCs) for the KDSQ-C, KDSQC-I, and KDSQ-C-II for diagnosing dementia were 0.75, 0.72, and 0.76, respectively; the corresponding AUCs for informant-completed questionnaires were 0.92, 0.89, and 0.92, indicating good discriminability for dementia.@*CONCLUSIONS@#A short form of the patient- and informant-rated versions of the KDSQ-C (KDSQ-C-II) is as capable as the 15-item KDSQ-C in screening for dementia.
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Background@#and Purpose: Previous studies suggest that cognitive intervention can mitigate the development of dementia in patients with mild cognitive impairment (MCI). However, the previous cognitive intervention was mostly provided as a group session, in which MCI patients sometimes had difficulty in regularly attending sessions or were reluctant to participate in group-based classes. Additionally, experienced instructors for traditional cognitive intervention may be unavailable in some chronic-care facilities or community centers. Considering these reasons, we have developed 5 programs for home-based cognitive intervention using a personal robot for MCI patients. In this preliminary study, we aimed to demonstrate the effects of our newly developed home-based cognitive intervention with robots on cognitive function in MCI patients. @*Methods@#We conducted a single-blind randomized controlled trial enrolling 46 MCI patients. Participants were randomized into 2 groups: the robot cognitive intervention (robot) (n=24) group and without cognitive intervention (control) (n=22) group. The interventions comprised 60-min sessions per day for 4 weeks. The primary outcome was the change in cognitive function measured using the Cambridge Neuropsychological Test Automated Battery. @*Results@#There were no significant baseline demographic or clinical differences between the robot and control groups. After the 4-week cognitive intervention, the robot group showed greater improvement in working memory than did the control group. @*Conclusions@#Our home-based cognitive intervention with a personal robot improved the working memory in MCI patients. Further studies with larger samples and longer study periods are required to demonstrate the effects of these programs in other cognitive domains in MCI patients.
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Background@#and PurposeThe 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.
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BACKGROUND AND PURPOSE: Cerebral small vessel disease (CSVD) is the most common cause of vascular dementia and a major contributor to mixed dementia. CSVD is characterized by progressive cerebral white matter changes (WMC) due to chronic low perfusion and loss of autoregulation. In addition to its antiplatelet effect, cilostazol exerts a vasodilating effect and improves endothelial function. This study aims to compare the effects of cilostazol and aspirin on changes in WMC volume in CSVD.METHODS: The comparison study of Cilostazol and aspirin on cHAnges in volume of cerebral smaLL vEssel disease white matter chaNGEs (CHALLENGE) is a double blind, randomized trial involving 19 hospitals across South Korea. Patients with moderate or severe WMC and ≥ 1 lacunar infarction detected on brain magnetic resonance imaging (MRI) are eligible; the projected sample size is 254. Participants are randomly assigned to a cilostazol or aspirin group at a 1:1 ratio. Cilostazol slow release 200 mg or aspirin 100 mg are taken once daily for 2 years. The primary outcome measure is the change in WMC volume on MRI from baseline to 104 weeks. Secondary imaging outcomes include changes in the number of lacunes and cerebral microbleeds, fractional anisotropy and mean diffusivity on diffusion tensor imaging, and brain atrophy. Secondary clinical outcomes include all ischemic strokes, all vascular events, and changes in cognition, motor function, mood, urinary symptoms, and disability.CONCLUSIONS: CHALLENGE will provide evidence to support the selection of long-term antiplatelet therapy in CSVD.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01932203