Change In Composite Score Research Articles

Slowing Cognitive Decline in Major Depressive Disorder and Mild Cognitive Impairment

Older adults with major depressive disorder (MDD) or mild cognitive impairment (MCI) are at high risk for cognitive decline. To assess the efficacy of cognitive remediation (CR) plus transcranial direct current stimulation (tDCS) targeting the prefrontal cortex in slowing cognitive decline, acutely improving cognition, and reducing progression to MCI or dementia in older adults with remitted MDD (rMDD), MCI, or both. This randomized clinical trial was conducted at 5 academic hospitals in Toronto, Ontario, Canada. Participants were older adults who had rMDD (with or without MCI, age ≥65 y) or MCI without rMDD (age ≥60 y). Assessments were made at baseline, month 2, and yearly from baseline for 3 to 7 years. CR plus tDCS (hereafter, active) or sham plus sham 5 days a week for 8 weeks followed by twice-a-year 5-day boosters and daily at-home CR or sham CR. The primary outcome was change in global composite cognitive score. Secondary outcomes included changes in 6 cognitive domains, moderating effect of the diagnosis, moderating effect of APOE ε4 status, change in composite score at month 2, and progression to MCI or dementia over time. Of 486 older adults who provided consent, 375 (with rMDD, MCI, or both) received at least 1 intervention session (mean [SD] age, 72.2 [6.4] years; 232 women [62%] and 143 men [38%]). Over a median follow-up of 48.3 months (range, 2.1-85.9), CR and tDCS slowed cognitive decline in older adults with rMDD or MCI (adjusted z score difference [active - sham] at month 60, 0.21; 95% CI, 0.07 to 0.35; likelihood ratio test [LRT] P = .006). In the preplanned primary analysis, CR and tDCS did not improve cognition acutely (adjusted z score difference [active - sham] at month 2, 0.06, 95% CI, -0.006 to 0.12). Similarly, the effect of CR and tDCS on delaying progression from normal cognition to MCI or MCI to dementia was weak and not significant (hazard ratio, 0.66; 95% CI, 0.40 to 1.08; P = .10). Preplanned analyses showed treatment effects for executive function (LRT P = .04) and verbal memory (LRT P = .02) and interactions with diagnosis (P = .01) and APOE ε4 (P < .001) demonstrating a larger effect among those with rMDD and in noncarriers of APOE ε4. The study showed that CR and tDCS, both targeting the prefrontal cortex, is efficacious in slowing cognitive decline in older adults at risk of cognitive decline, particularly those with rMDD (with or without MCI) and in those at low genetic risk for Alzheimer disease. ClinicalTrials.gov Identifier: NCT02386670.

An 18-month multimodal intervention trial for preventing dementia: J-MINT PRIME Tamba.

The number of people with dementia is increasing in Japan, and establishing evidence for preventing dementia is necessary. This study was a randomized controlled trial in cognitively normal community-dwelling older adults aged 65 to 85 with diabetes and/or hypertension. Participants were randomly assigned in a 1:1 ratio. The intervention group underwent 90min of group-based weekly physical exercise, cognitive training, nutritional counseling, and vascular risk management for 18 months. The primary endpoint was the change in a cognitive composite score calculated by averaging the z-scores of seven neuropsychological tests from baseline to 18 months. We randomly assigned 203 participants to two groups, and 178 (87.7%) completed the 18-month follow-up. There was a significant group difference in the cognitive composite score change at 18 months (mean difference 0.16, 95% confidence interval: 0.04 to 0.27; p=0.009). An 18-month multimodal intervention for older adults at risk of dementia could improve their cognitive function. The trial was registered in the Clinical Trial Registration System (UMIN000041938). Japan-Multimodal Intervention Trial for Prevention of Dementia (J-MINT) PRIME Tamba was a randomized controlled trial to prevent dementia. We provided a multifactorial intervention based on the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) trial methodology. The primary outcome, the cognitive composite score, improved with our intervention. Executive function/processing speed and memory improved in the intervention group. Intervention adherence was high, and no serious adverse events occurred.

Training to Increase Minority Enrollment in Lupus Clinical Trials With Community Engagement: Enhancing Lupus Clinical Trial Recruitment Through Provider and Community Health Worker Engagement.

This study evaluates the effectiveness of the Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement (TIMELY) program on enhancing referrals of underrepresented patients to lupus clinical trials. TIMELY leverages two existing American College of Rheumatology online educational initiatives: Materials to Increase Minority Involvement in Clinical Trials (MIMICT), a continuing medical education activity for health care providers, and the community health worker (CHW) Lupus Clinical Trials Training (LuCTT). TIMELY introduced a unique roundtable meeting format to build on the existing online educational programs and facilitate discussions between local clinical trial sites and provider and CHW participants. This study used an online pretest and posttest design to assess changes in theory-based behavioral predictors of lupus clinical trial referrals and engagement (ie, knowledge, attitudes, self-efficacy, and intentions) among providers and CHWs. Participants completed MIMICT or LuCTT and then were eligible to participate in roundtable meetings. Paired t-tests were used to assess changes in composite scores before and after the intervention for each of the outcomes. The final sample included 40 providers and 18 CHWs. Knowledge scores increased significantly for both providers (P < 0.01) and CHWs (P < 0.001) on completion of MIMICT and LuCTT, respectively. After participating in the TIMELY roundtable, providers' composite scores for self-efficacy and intentions significantly increased (P < 0.001). Provider self-efficacy gains were sustained at three months' follow-up (P < 0.001). These promising findings highlight the potential and opportunities for the TIMELY program to improve behavioral predictors of trial referrals, including CHW knowledge and providers' knowledge, self-efficacy, and intentions to refer underrepresented patients to lupus clinical trials.

Neonatal neurobehavior associated with developmental changes from age 2 to 3 in very preterm infants

ObjectiveUnderstand how high-risk infants' development changes over time. Examine whether NICU Network Neurobehavioral Scale (NNNS) profiles are associated with decrements in developmental outcomes between ages 2 and 3 years in infants born very preterm. Study designThe Neonatal Outcomes for Very preterm Infants (NOVI) cohort is a multisite prospective study of 704 preterm infants born <30 weeks' gestation across nine university and VON affiliated NICUs. Data included infant neurobehavior measured by NNNS profiles at NICU discharge and the Bayley Scales of Infant and Toddler Development (BSID-III) at ages 2 and 3 years. Generalized estimating equations tested associations between NNNS profiles and BSID-III composite score changes between ages 2 and 3 years. ResultsThe final study sample included 433 infants with mean gestational age of 27 weeks at birth. Infants with dysregulated NNNS profiles were more likely to have decreases in BSID-III Cognitive (OR = 2.66) and Language scores (OR = 2.53) from age 2 to 3 years compared to infants with more well-regulated neurobehavioral NNNS profiles. Further, infants with more well-regulated NNNS profiles were more likely to have increases in BSID-III Cognitive scores (OR = 2.03), rather than no change, compared to infants with dysregulated NNNS profiles. Conclusions and relevancePrior to NICU discharge, NNNS neurobehavioral profiles identified infants at increased risk for developing later language and cognitive challenges. Findings suggests that neonatal neurobehavior provides a unique, clinically significant contribution to the evaluation of very preterm infants to inform treatment planning for the most vulnerable.

Japan-Multimodal Intervention Trial for the Prevention of Dementia: A randomized controlled trial.

We examined the efficacy of a multidomain intervention in preventing cognitive decline among Japanese older adults with mild cognitive impairment (MCI). Participants aged 65-85 years with MCI were randomized into intervention (management of vascular risk factors, exercise, nutritional counseling, and cognitive training) and control groups. The primary outcome was changes in the cognitive composite score over a period of 18 months. Of 531 participants, 406 completed the trial. The between-group difference in composite score changes was 0.047 (95% CI: -0.029 to 0.124). Secondary analyses indicated positive impacts of interventions on several secondary health outcomes. The interventions appeared to be particularly effective for individuals with high attendance during exercise sessions and those with the apolipoprotein E ε4 allele and elevated plasma glial fibrillary acidic protein levels. The multidomain intervention showed no efficacy in preventing cognitive decline. Further research on more efficient strategies and suitable target populations is required. This trial evaluated the efficacy of multidomain intervention in individuals with MCI. The trial did not show a significant difference in preplanned cognitive outcomes. Interventions had positive effects on a wide range of secondary health outcomes. Those with adequate adherence or high risk of dementia benefited from interventions.

Enhanced External Counterpulsation Improves Cognitive Function of Persons With Long COVID.

The aim of this study is to determine the effects of enhanced external counterpulsation (EECP) in patients with long COVID and objectively assessed cognitive impairment. A retrospective evaluation of long COVID patients referred for EECP, with cognitive sequela, and having completed an objective digital assessment before and after therapy. Patients had either cognitive impairment or no cognitive impairment at baseline. We assessed changes in composite score using multifactor analysis of variance. Multiple linear and logistic regression analyses were conducted to evaluate several independent variables. Eighty long COVID patients (38 cognitive impairment vs. 42 no cognitive impairment) were included for analyses. All baseline characteristics were well matched. There was significant improvement in composite score post EECP in those with objective cognitive impairment at baseline. There were no notable documented safety concerns. This is the first study showing that EECP led to significant improvement in cognitive functioning of long COVID patients with objectively defined cognitive impairment. Although a lack of a negative control group is a limitation of this study, EECP seems to be highly safe and effective with the potential for widespread application.

The PACt‐MD randomized clinical trial: Prevention of Alzheimer’s dementia with Cognitive remediation plus transcranial direct current stimulation in Mild cognitive impairment and Depression

AbstractBackgroundInterventions to prevent cognitive decline and dementia in high‐risk populations such as those with remitted Major Depressive Disorder (rMDD) or Mild Cognitive Impairment (MCI) are urgently needed.MethodPACt‐MD was a double‐blind randomized trial conducted between 2015 and 2022 comparing cognitive remediation (CR) plus transcranial Direct Current Stimulation (tDCS) vs. sham‐CR+sham‐tDCS delivered 5 days/week for 8 weeks followed by 5‐day semi‐annual boosters and at‐home daily CR, in participants with rMDD or MCI. Participants were assessed at baseline, week‐8, and yearly.The hypotheses were that compared to sham+sham, CR+tDCS would: slow cognitive decline (H1); reduce progression to MCI or dementia (H2); and acutely improve cognition (H3).The primary outcome composite score was calculated when at least half of the tests for at least four of six cognitive domains were completed. Due to COVID‐19, some participants did not complete enough tests and a second composite score using all available data was generated.Result375 participants were randomized (Active: N = 188, Mean Age = 72.1 ± 6.3; Sham: N = 187, Mean Age = 72.3 ± 6.4) and received at least one intervention session. Over up to six years, there was no time‐by‐treatment interaction using the primary composite score but there was using the all‐data score. Change in composite score differed between the two intervention groups for the primary and all‐data scores for all years except for year‐6 primary score. The year‐5 adjusted z‐score difference was ‐0.15 (95%CI [‐0.29, ‐0.005]) for the primary and ‐0.21 (95%CI [‐0.34, ‐0.067]) for all‐data score (Fig.1). Comparing active vs. sham at 8‐week (H3), the adjusted z‐score difference was ‐0.06 (95%CI: [‐0.12, 0.005]; p = 0.072); and for progression (H2), HR was 0.66 (95%CI [0.40, 1.08] p = 0.101) in a stratified Cox model. In a preplanned secondary analysis of domain scores, there was a time‐by‐treatment interaction for verbal memory with a year‐5 adjusted z‐score difference of ‐0.30 (95%CI [‐0.53, ‐0.074]) (Fig.2) but not the other domains. In another preplanned secondary analysis, the model with a randomization diagnosis‐by‐time‐by‐treatment was different from the model without this three‐way interaction (p = 0.012; Fig.3).ConclusionCR+tDCS may be effective in slowing cognitive decline (particularly verbal memory) in older patients with rMDD or MCI.

Nivolumab for Patients With High-Risk Oral Leukoplakia

Proliferative verrucous leukoplakia (PVL) is an aggressive oral precancerous disease characterized by a high risk of transformation to invasive oral squamous cell carcinoma (OSCC), and no therapies have been shown to affect its natural history. A recent study of the PVL immune landscape revealed a cytotoxic T-cell-rich microenvironment, providing strong rationale to investigate immune checkpoint therapy. To determine the safety and clinical activity of anti-programmed cell death 1 protein (PD-1) therapy to treat high-risk PVL. This nonrandomized, open-label, phase 2 clinical trial was conducted from January 2019 to December 2021 at a single academic medical center; median (range) follow-up was 21.1 (5.4-43.6) months. Participants were a population-based sample of patients with PVL (multifocal, contiguous, or a single lesion ≥4 cm with any degree of dysplasia). Patients underwent pretreatment biopsy (1-3 sites) and then received 4 doses of nivolumab (480 mg intravenously) every 28 days, followed by rebiopsy and intraoral photographs at each visit. The primary end point was the change in composite score (size and degree of dysplasia) from before to after treatment (major response [MR]: >80% decrease in score; partial response: 40%-80% decrease). Secondary analyses included immune-related adverse events, cancer-free survival (CFS), PD-1 ligand 1 (PD-L1) expression, 9p21.3 deletion, and other exploratory immunologic and genomic associations of response. A total of 33 patients were enrolled (median [range] age, 63 [32-80] years; 18 [55%] were female), including 8 (24%) with previously resected early-stage OSCC. Twelve patients (36%) (95% CI, 20.4%-54.8%) had a response by composite score (3 MRs [9%]), 4 had progressive disease (>10% composite score increase, or cancer). Nine patients (27%) developed OSCC during the trial, with a 2-year CFS of 73% (95% CI, 53%-86%). Two patients (6%) discontinued because of toxic effects; 7 (21%) experienced grade 3 to 4 immune-related adverse events. PD-L1 combined positive scores were not associated with response or CFS. Of 20 whole-exome sequenced patients, all 6 patients who had progression to OSCC after nivolumab treatment exhibited 9p21.3 somatic copy-number loss on pretreatment biopsy, while only 4 of the 14 patients (29%) who did not develop OSCC had 9p21.3 loss. This immune checkpoint therapy precancer nonrandomized clinical trial met its prespecified response end point, suggesting potential clinical activity for nivolumab in high-risk PVL. Findings identified immunogenomic associations to inform future trials in this precancerous disease with unmet medical need that has been difficult to study. ClinicalTrials.gov Identifier: NCT03692325.

68 Preliminary Evidence of a Therapeutic Effect of Electrical Neuromodulation on Cognitive Deficits in Patients with Mild Cognitive Impairment

Objective:Episodic memory functioning is distributed across two brain circuits, one of which courses through the dorsal anterior cingulate cortex (dACC). Thus, delivering non-invasive neuromodulation technology to the dACC may improve episodic memory functioning in patients with memory problems such as in amnestic mild cognitive impairment (aMCI). This preliminary study is a randomized, double-blinded, sham-controlled clinical trial to examine if high definition transcranial direct current stimulation (HD-tDCS) can be a viable treatment in aMCI.Participants and Methods:Eleven aMCI participants, of whom 9 had multidomain deficits, were randomized to receive 1 mA HD-tDCS (N=7) or sham (N=4) stimulation. HD-tDCS was applied over ten 20-minute sessions targeting the dACC. Neuropsychological measures of episodic memory, verbal fluency, and executive function were completed at baseline and after the last HD-tDCS session. Changes in composite scores for memory and language/executive function tests were compared between groups (one-tailed t-tests with a = 0.10 for significance). Clinically significant change, defined as &gt; 1 SD improvement on at least one test in the memory and non-memory domains, was compared between active and sham stimulation based on the frequency of participants in each.Results:No statistical or clinically significant change (N-1 X2; p = 0.62) was seen in episodic memory for the active HD-tDCS (MDiff = 4.4; SD = 17.1) or sham groups (MDiff = -0.5; SD = 9.7). However, the language and executive function composite showed statistically significant improvement (p = 0.04; MDiff = -15.3; SD = 18.4) for the active HD-tDCS group only (Sham MDiff = -5.8; SD = 10.7). Multiple participants (N=4) in the active group had clinically significant enhancement in language and executive functioning tests, while nobody in the sham group did (p = 0.04).Conclusions:HD-tDCS targeting the dACC had no direct benefit for episodic memory deficits in aMCI based on preliminary findings for this ongoing clinical trial. However, significant improvement in language and executive function skills occurred in response to HD-tDCS, suggesting HD-tDCS in this configuration has promising potential as an intervention for language and executive function deficits in MCI.

Associations between healthcare costs and care experiences among older adults with and without cancer

IntroductionCare coordination and patient-provider communication are important for older adults with cancer, as they likely have additional, non-cancer chronic conditions requiring consultation across multiple providers. Suboptimal care coordination and patient-provider communication can lead to costly and preventable adverse outcomes. This study examines Medicare expenditures associated with patient-reported care coordination and patient-provider communication among older adults with and without cancer. Materials and MethodsWe explore SEER-CAHPS® (Surveillance, Epidemiology and End Results-Consumer Assessment of Healthcare Providers and Systems) linked data for differences in health care expenditures by care coordination and patient-provider communication experiences for beneficiaries with and without cancer. The cancer cohort included beneficiaries with ten prevalent cancer types diagnosed 2011–2019 at least six months before completing a CAHPS survey. Medicare expenditures were abstracted from Medicare claims data. Care coordination and patient-provider communication composite scores (range 0–100, higher scores indicate better experiences) were patient-reported in the CAHPS® survey. We estimated expenditure differences per one-point change in composite scores for patients with and without cancer. ResultsOur analysis included 16,778 matched beneficiaries with and without a previously diagnosed cancer (N = 33,556). Higher care coordination and patient-provider communication scores were inversely associated with Medicare expenditures among beneficiaries with and without cancer in the six months prior to survey response, ranging from -$83 (standard error [SE] = $7) to -$90 (SE = $6) per month. Six months post-survey, expenditures estimates ranging -$88 (SE = $6) to -$106 (SE = $8) were found. DiscussionWe found that lower Medicare expenditures were associated with higher care coordination and patient-provider communication scores. As the number of survivors living longer both with and beyond their cancer grows, addressing their multifaceted care and improving outcomes will be critical.

Visit-to-Visit Blood Pressure Variability and Cognitive Decline in Apolipoprotein ɛ4 Carriers versus Apolipoprotein ɛ3 Homozygotes.

Blood pressure variability (BPV) is associated with cognitive decline and Alzheimer's disease (AD), but relationships with AD risk gene apolipoprotein (APOE) ɛ4 remain understudied. Examined the longitudinal relationship between BPV and cognitive change in APOE ɛ4 carriers and APOE ɛ3 homozygotes. 1,194 Alzheimer's Disease Neuroimaging Initiative participants (554 APOE ɛ4 carriers) underwent 3-4 blood pressure measurements between study baseline and 12-month follow-up. Visit-to-visit BPV was calculated as variability independent of mean over these 12 months. Participants subsequently underwent ≥1 neuropsychological exam at 12-month follow-up or later (up to 156 months later). Composite scores for the domains of memory, language, executive function, and visuospatial abilities were determined. Linear mixed models examined the 3-way interaction of BPV×APOE ɛ4 carrier status x time predicting change in composite scores. Higher systolic BPV predicted greater decline in memory (+1 SD increase of BPV: β= -0.001, p < 0.001) and language (β= -0.002, p < 0.0001) among APOE ɛ4 carriers, but not APOE ɛ3 homozygotes (memory: +1 SD increase of BPV: β= 0.0001, p = 0.57; language: β= 0.0001, p = 0.72). Systolic BPV was not significantly associated with change in executive function or visuospatial abilities in APOE ɛ4 carriers (ps = 0.08-0.16) or APOE ɛ3 homozygotes (ps = 0.48-0.12). Cognitive decline associated with high BPV may be specifically accelerated among APOE ɛ4 carriers.

Abstract 11679: Simple Text-Messaging and Social Support to Increase Hypertension Medication Adherence in Non-Hispanic Black Adults in New Orleans, LA

Introduction: Non-Hispanic Black adults (NHB) have the highest US CVD risk, the leading cause of mortality. Medication nonadherence predicts suboptimal HTN control. Self-measured blood pressure (SMBP) effectively tracks BP changes and medication response. Purpose: This New Orleans, LA predominantly NHB single cohort pilot study examined uncontrolled HTN utilizing bidirectional electronic messaging (BEM) with an interdisciplinary healthcare team assessing medication adherence, quality of life (QOL), and BP, without pharmacotherapeutic change. Methods: Participants were screened from Tulane Cardiology Clinic and community sources. Eligibility criteria included: uncontrolled HTN (BP &gt;130/80 mmHg), low Krousel-Wood (KW) adherence score, and smartphone access. Participants (n=36) were provided validated bluetooth-enabled BP devices synced to smartphones via a cloud-based BP recording app. Demographic information included: age, self-identified race (91.7% NHB), and sex. Pre- and post-study KW adherence scores, CDC Health Related QOL surveys, BMI and BP were obtained. Participants were followed with BEM for 8 weeks with SMBP and daily text reminders. Results: Mean age was 58.7±12.8 years; mean BMI was 34.8±7.8; 63.9% were female; 25.7 % with previous diabetes diagnosis; 72% with obesity. Nonadherence significantly improved with mean KW adherence composite score change from 2.19 to 1.58 (p = 0.0001). Mean baseline SBP/DBP was 142.19/81.19; SBP decreased significantly by mean 10.5±20.0 mmHg (p = 0.0027) with no significant change in DBP. There was a non-significant decline in the average summary index of unhealthy days during the previous 30 days from 9.1 days to 6.8 days, change -2.3 ± 10.7 (p = 0.21). Conclusions: A novel approach combining cloud-based bluetooth SMBP transmission with BEM health communication significantly improved medication adherence and systolic BP in a predominantly NHB urban cohort without modifying existing pharmacotherapy. “Supported in part by U54 GM104940 from the National Institute of General Medical Sciences of NIH, which funds the LA Clinical and Translational Science Center. Content is solely the responsibility of the authors and does not necessarily represent official views of the NIH.”

650O A phase II study of nivolumab for high-risk oral leukoplakia

Oral proliferative leukoplakia (PL) is an aggressive precancerous disease characterized by multifocal lesions and a high-risk of transformation to oral squamous cell carcinoma (OSCC). There are no effective therapies that prevent progression to oral cancer. PL demonstrates a rich immune microenvironment, providing strong rationale to evaluate PD-1 blockade as preventative immunotherapy. This single-arm, phase 2 trial investigated nivolumab (N) among patients (pts) with PL (multifocal, contiguous, or a single lesion ≥4 cm with any degree of epithelial dysplasia); a history of previously treated early-stage OSCC was permitted. Pts underwent pre-treatment biopsy of 1-3 sites then received 4 doses of N (480 mg IV) every 28-days, followed by re-biopsy. Intraoral photographs and bidirectional measurements occurred at each visit. Primary endpoint: change in composite score (size and degree of dysplasia) pre- to post-treatment (CR: >80% decrease in score; PR: 40-80% decrease; PD: ≥10% increase in composite score or new OSCC). Secondary endpoints: safety, cancer-free survival (CFS). Exploratory aims: PD-L1 status, genomic and immune profiling parameters. Between 1/2019 and 12/2021, 33 pts enrolled; 30 evaluable to date. Median age: 64 (range: 32-80), mostly women (18, 60%), 16 (53%) former/current smokers; oral tongue (13, 43%) was the main disease subsite; 8 (27%) had prior OSCC. A decrease of ≥40% in composite score was observed in 37% of pts (3 CRs and 8 PRs); 14 (47%) had stable disease, 4 experienced PD. 26 (86%) completed all 4 doses of N; 2 (7%) discontinued for toxicity, 2 (7%) for PD. Grade 3-4 irAEs were noted among 7 (23%) pts (hyperglycemia, colitis, hepatitis). At median follow-up of 16.3 mos (4.1-34.3+), median CFS was not reached, with 7 (23%) cancer events observed (3 among prior responders); 1-year CFS: 76.5% (95%CI 54.5-88.8). All pts are alive at last follow-up. Baseline median PD-L1 CPS trended higher among responders (15 vs. 5, p=0.10). Nivolumab yielded a best response of PL regression among 37% of pts with a favorable overall CFS. This is the first study to demonstrate evidence of efficacy using preventative immunotherapy for high-risk oral precancerous disease.

P098 Changes in Availability of Healthy Food in Homes of Participants in TX Sprouts, a School-Based Gardening, Nutrition, and Cooking Program

<h3>Objective</h3> To evaluate the effects of a school-based gardening, nutrition, and cooking intervention (TX Sprouts) compared to control on the availability of vegetables and sugar-sweetened beverages (SSBs) at home. <h3>Use of Theory or Research</h3> TX Sprouts was based on the social ecological-transactional model with a goal of empowering children to make positive changes in their family environments. <h3>Target Audience</h3> Children ages 7-11 attending public schools serving primarily low-income, Hispanic children and their families. <h3>Program Description</h3> TX Sprouts includes building an edible garden at the school and teaching 18 in-school gardening, nutrition, and cooking lessons to all 3rd-5th grade students. Lessons focused on increasing vegetables and decreasing SSBs. <h3>Evaluation Methods</h3> In a randomized-controlled trial, 16 schools were randomly assigned to TX Sprouts or control (i.e., delayed intervention) for one academic year. Parents completed a 7-item survey about the availability of vegetables and SSBs in the home at pre and post. Analyses of variance tests were used to evaluate the changes in home vegetable and SSB availability (composite score and individual questions) between intervention and control, adjusted for child's age, ethnicity, and SNAP participation. <h3>Results</h3> The analytic sample included 895 children (n = 414 intervention, n = 481 control) whose parents completed the survey at baseline and endpoint. The intervention resulted in a significant improvement in the overall availability of healthy food (more vegetables, fewer SSBs) in the home when compared to the control (composite score change 0.29 vs. -0.24; <i>P =</i> 0.012). When examining individual questions in the survey, families receiving the intervention significantly improved home availability of fresh vegetables (0.03 vs. -0.1; <i>P =</i> 0.039). <h3>Conclusions</h3> A gardening, nutrition, and cooking program delivered to children in schools can benefit children by increasing healthy food in the home environment. <h3>Funding</h3> NIH; Whole Kids Foundation; Home Depot; Sprouts Healthy Communities

Evaluation of liraglutide in the treatment of Alzheimer's disease

AbstractBackgroundLiraglutide is a glucagon‐like peptide‐1 (GLP‐1) analogue licensed for the treatment of type 2 diabetes. Preclinical evidence in transgenic models of Alzheimer’s disease suggests that liraglutide exerts neuroprotective effects by reducing amyloid oligomers, normalising synaptic plasticity and cerebral glucose uptake, and increasing the proliferation of neuronal progenitor cells.MethodsELAD is a 12‐month, multi‐centre, randomised, double‐blind, placebo‐controlled, phase IIb trial of liraglutide in participants with mild to moderate Alzheimer’s dementia, conducted at several centres in the UK – (NCT01843075). [18F]FDG‐PET and MRI brain scans of all patients will be performed at baseline and after 12 months treatment with liraglutide or matching placebo. Once enrolled, all subjects had a neuropsychological battery of tests All scans and tests will be repeated after 12 months. A total of 204 participants were randomised to receive either liraglutide or placebo as a daily subcutaneous injection for 12 months. The primary objective was to evaluate the change in cerebral glucose metabolic rate in the cortical regions (hippocampus, medial temporal lobe, and posterior cingulate) from baseline to 12‐month follow‐up in participants with Alzheimer’s disease receiving treatment with liraglutide compared to those receiving placebo. The key secondary outcomes were the change from baseline to 12 months in z scores for clinical and cognitive measures (Alzheimer’s Disease Assessment Scale – Cognitive Subscale and Executive domain scores of the Neuropsychological Test Battery, Clinical Dementia Rating Sum of Boxes, and Alzheimer’s Disease Cooperative Study – Activities of Daily Living) and the incidence and severity of treatment‐emergent adverse events or clinically important changes in safety assessments. Other secondary outcomes were 12‐month change in magnetic resonance imaging volume, diffusion tensor imaging parameters, and changes in composite scores using support machine vector analysis in the treatment group compared with the placebo group.ResultsThe study demonstrated that liraglutide treated patients performed significantly better than placebo arm in temporal lobe and whole cortical MRI volume and cognitive function measured by ADAS‐EXEC (ADAS‐Cog with Executive domains of the Neuropsychological Test Battery).ConclusionThis demonstrates that GLP1 analogues can improve cognitive function and MRI volume in AD subjects and could be a potential treatment for treatment for Alzheimer's

A Comparative Study of Safety and Efficacy of Oral Terbinafine and Itraconazole in Patients of Tinea Corporis/ Tinea Cruris Infection, A Randomized Open Label Parallel Group Study

Introduction: Superficial dermatophytosis is a common public health problem in India, due to its tropical climate with heat and humidity. Today, the triazoles, mainly Itraconazole and the allylamines, chiefly Terbinafine, are the main ammunitions against dermatophytes. This study is undertaken to compare the safety and efficacy of both the drugs. Materials and Methods: This study was conducted to find the efficacy of Oral Terbinafine and Oral Itraconazole in Tinea Corporis/Tinea Cruris infection. The primary efficacy parameter was change in composite score (pruritus, erythema, pigmentations) from baseline to end of the treatment period. And to compare the safety of Oral Terbinafine and Oral Itraconazole by comparing the following parameters, Liver enzymes - SGOT/SGPT before and after treatment with the study drugs. Drug Dosage: Group 1: Drug –Tab. Terbinafine: Dose 500 mg per day once daily at bedtime for 2 weeks. Group 2: Drug –Tab. Itraconazole: Dose 200 mg per day, once daily at bedtime for 2 weeks. Results: The study participants show significant reduction in itching at the second follow up (after 2 weeks of drug completion) in both groups. Pruritis was reduced in 92% subjects in group 1 and 97.5% subjects in group 2. There was 87% reduction in erythema in group 1 and 93% reduction in group 2. Pigmentations were seen in 2% subjects in both groups indicating relapse of infection. Conclusion: The significant outcome of the study was that oral Itraconazole 200mg/day for 14 days(2 weeks) can be the better antifungal.

Task-specific movement training improves kinematics and pain during the Y-balance test and hip muscle strength in females with patellofemoral pain

ObjectivesTask-specific movement training is a proposed intervention for patellofemoral pain aimed to optimise movement during daily tasks. Focused, progressive task practice emphasising optimal limb alignment may yield improvements in performance-based function and hip muscle strength, and transfer learnt movement patterns to untrained tasks. The purpose of this study was to determine if task-specific movement training improves performance-based function (composite score, movement, pain during movement) in an untrained task. Our secondary purpose was to test whether hip muscle strength improved following the movement training intervention.MethodsThis study was a secondary analysis of a prospective, non-randomised, within-group, double-baseline study. Twenty-three females with patellofemoral pain underwent task-specific movement training two times/week for 6 weeks. Outcomes were collected at three time points: enrolment (baseline), 6 weeks (preintervention) and 12 weeks (postintervention). A repeated measures analysis of variance tested whether the change during the intervention phase was greater than the change during the control phase. Y-balance composite score, hip and knee kinematics and pain during the Y-balance test were primary outcome measures; strength of the hip lateral rotator, abductor and extensor muscles was a secondary outcome measure.ResultsThe change in composite score for the Y-balance test was not statistically significantly different between the intervention and control phases (p=0.16). The change during the intervention phase exceeded the change during the control phase for hip and knee kinematics and pain during the Y-balance test, with all variables improving (p<0.0001). The change during the intervention phase was greater than the control phase for hip muscle strength, with all variables improving (p<0.04).ConclusionAlthough the Y-balance test composite score did not improve, performance-based function during an untrained task, measured by movement and pain during the test, improved following task-specific movement training. Hip muscle strength improved, despite no focused muscle strengthening.Level of evidenceLevel II.

Effect of cataract surgery on vision-related quality of life among cataract patients with high myopia: a prospective, case-control observational study.

To evaluate the effect of cataract surgery on vision-related quality of life (VR-QOL) in cataract patients with high myopia (HM). In this prospective study, 90 patients with bilateral HM (HM group, mean [SD] age, 62.9 [9.7] years) and 90 age-matched patients with normal axial lengths (ALs) (control group) who underwent phacoemulsification surgery were consecutively included. The VR-QOL was evaluated using the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) preoperatively and 6 months postoperatively. During the same periods, the best-corrected visual acuity (BCVA) was recorded. Postoperatively, the BCVA improved significantly in the HM group, with 78 patients (86.7%) achieving improvements ≥0.2 logMAR units, higher than that in the control group (61.1%, P < 0.001). Although the preoperative NEI-VFQ-25 composite score was lower in the HM group than in the control group (65.8 ± 4.7 [95% CI] versus 77.3 ± 3.8, P < 0.001), the postoperative composite score was not significantly different between the two groups (87.5 ± 2.6 versus 90.4 ± 1.6, P = 0.126); changes in composite score and scores of 7 subscales were greater in the HM group than in the control group (P < 0.05 for all). In the HM group, but not in the control group (r = -0.019, P = 0.860), patient age was negatively associated with the change in composite score (r = -0.235, P = 0.026). Preoperative BCVA (logMAR) was positively associated with changes in composite score for both groups (r = 0.796 and 0.714, respectively, P < 0.001 for both). VR-QOL is significantly impaired in cataract patients with HM and is remarkably improved by cataract surgery. The improvement is greater than that in normal AL cases.

Effects of smartphone application-based cognitive training at home on cognition in community-dwelling non-demented elderly individuals: A randomized controlled trial.

IntroductionWe investigated whether cognitive function improves in elderly individuals after Application‐based Cognitive Training at Home (ACTH) for 12 months.MethodsA total of 389 non‐demented elderly volunteers aged over 60 years were recruited and randomly assigned to the intervention or control group. The intervention group underwent daily ACTH (with regular feedback from the administrator) and monthly offline cognitive training in groups for 12 months. All participants received a computerized cognitive test battery called Inbrain Cognitive Screening Test (Inbrain‐CST) at baseline and 6 and 12 months. The primary outcome was the change in the total composite score of Inbrain‐CST, and secondary outcomes included changes in composite scores in five cognitive domains of Inbrain‐CST.ResultsThe intervention group outperformed the control group in terms of the total score (P = .001) and subscores of language (P < .001) and memory (P < .001) domains at 12 months.DiscussionACTH improved global cognition in community‐dwelling non‐demented elderly individuals.

The effect of smartphone app‐based cognitive training on cognition in community‐dwelling elderly: A randomized controlled trial

AbstractBackgroundMost of previous cognitive intervention studies provided group cognitive intervention for a short period of time, which are limited by requirement of money, time, and space in real clinical circumstances. Therefore, easily accessible way of cognitive training should be developed and tested in a large cohort of the elderly. We investigated the effectiveness of smartphone app (InBrain Trainer) based cognitive training for 12 months on cognitive improvement in the community‐dwelling healthy elderly.MethodThis App‐based Cognitive Training at Home (ACTH) study is a randomized, single‐masked, parallel group study, which was conducted between March 2018 to August 2019 at Gangnam Center for Dementia, in Seoul, South Korea. We recruited 389 healthy volunteers aged over 60 and they were randomly assigned to the intervention or control group. The intervention group experienced daily app‐based cognitive training at home (with regular feedback from administrator) and monthly group cognitive training for 12 months. All participants underwent cognitive screening test (CST) at baseline, 6 and 12 months. The primary outcome was the change in total composite score on CST, and the secondary outcomes included changes in composite scores of five cognitive domains, which were assessed using linear mixed effects models.ResultWhen the intervention‐by‐visit interaction effect was investigated, the intervention group showed a larger increase on total scores (p &lt; 0.001 at 6 months, p = 0.001 at 12 months), on language (p &lt;0.001 both at 6 and 12 months) and memory composite scores (p=0.006 at 6 months, p&lt;0.001 at 12 months) compared to the control group. There was no significant difference in changes at 12 months in attention (p=0.72), visuospatial (p=0.994) and executive composite scores (p = 0.929) between the intervention and the control group. (Figure 1)ConclusionThis study demonstrated that app‐based cognitive training could enhance general cognition in the healthy elderly. Therefore, this cognitive training tool could be usefully utilized for the purpose of preventing cognitive decline on a community basis.