Search

Introduction: PRESENCE was a phase 2 clinical trial assessing the efficacy of mevidalen, a D1 receptor positive allosteric modulator, for symptomatic treatment of Lewy body dementia (LBD). Mevidalen demonstrated improvements in motor and non-motor features of LBD, global functioning, and actigraphy-measured activity and daytime sleep. Adverse events (AEs) of fall were numerically increased in mevidalen-treated participants. Methods: A subset of PRESENCE participants wore a wrist actigraphy device for 2-week periods pre-, during, and posttreatment. Actigraphy sleep and activity measures were derived per period and analyzed to assess for their association with participants’ reports of an AE of fall. Prespecified baseline and treatment-emergent clinical characteristics were also included in the retrospective analysis of falls. Independent-samples t test and χ2 test were performed to compare the means and proportions between individuals with/without falls. Results: A trend toward more falls was observed with mevidalen treatment (31/258 mevidalen-treated vs. 4/86 in placebo-treated participants: p = 0.12). Higher body mass index (BMI) (p < 0.05), more severe disease measured by baseline Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part II (p < 0.05), and a trend toward improved Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13) (p = 0.06) were associated with individuals with falls. No statistically significant associations with falls and treatment-emergent changes were observed. Conclusion: The association of falls with worse baseline disease severity and higher BMI and overall trend toward improvements on cognitive and motor scales suggest that falls in PRESENCE may be related to increased activity in mevidalen-treated participants at greater risk for falling. Future studies to confirm this hypothesis using fall diaries and digital assessments are necessary.

Abstract In 2019, the Lewy Body Dementia Association formed an Industry Advisory Council to bring together a collaborative group of stakeholders with the goal of accelerating clinical research into Lewy body dementia treatments. At the second annual meeting of the Industry Advisory Council, held virtually on June 18, 2020, the key members presented ongoing and planned efforts toward the council’s goals. The meeting also featured a discussion about the effects of the COVID-19 pandemic on Lewy body dementia clinical research, lessons learned from that experience, and how those lessons can be applied to the design and conduct of future clinical trials. This report provides a brief summary of the meeting proceedings with a focus on efforts to improve and adapt future Lewy body dementia clinical research.

Abstract Background This paper describes the development and psychometric evaluation of a behavioral assessment instrument primarily intended for use with workgroups in any type of organization. The instrument was developed based on the Nurturing Environments framework which describes four domains important for health, well-being, and productivity; minimizing toxic social interactions, teaching and reinforcing prosocial behaviors, limiting opportunities for problem behaviors, and promoting psychological flexibility. The instrument is freely available to use and adapt under a CC-BY license and intended as a tool that is easy for any group to use and interpret to identify key behaviors to improve their psychosocial work environment. Methods Questionnaire data of perceived frequency of behaviors relevant to nurturance were collected from nine different organizations in Sweden. Data were analyzed using confirmatory factor analysis, Rasch analysis, and correlations to investigate relationships with relevant workplace measures. Results The results indicate that the 23-item instrument is usefully divided in two factors, which can be described as risk and protective factors. Toxic social behaviors make up the risk factor, while the protective factor includes prosocial behavior, behaviors that limit problems, and psychological flexibility. Rasch analysis showed that the response categories work as intended for all items, item fit is satisfactory, and there was no significant differential item functioning across age or gender. Targeting indicates that measurement precision is skewed towards lower levels of both factors, while item thresholds are distributed over the range of participant abilities, particularly for the protective factor. A Rasch score table is available for ordinal to interval data transformation. Conclusions This initial analysis shows promising results, while more data is needed to investigate group-level measurement properties and validation against concrete longitudinal outcomes. We provide recommendations for how to work in practice with a group based on their assessment data, and how to optimize the measurement precision further. By using a two-dimensional assessment with ratings of both frequency and perceived importance of behaviors the instrument can help facilitate a participatory group development process. The Group Nurturance Inventory is freely available to use and adapt for both commercial and non-commercial use and could help promote transparent assessment practices in organizational and group development.

Abstract Objective The expanding power and accessibility of personal technology provide an opportunity to reduce burdens and costs of traditional clinical site‐centric therapeutic trials in Parkinson’s disease and generate novel insights. The value of this approach has never been more evident than during the current COVID‐19 pandemic. We sought to (1) establish and implement the infrastructure for longitudinal, virtual follow‐up of clinical trial participants, (2) compare changes in smartphone‐based assessments, online patient‐reported outcomes, and remote expert assessments, and (3) explore novel digital markers of Parkinson’s disease disability and progression. Methods Participants from two recently completed phase III clinical trials of inosine and isradipine enrolled in Assessing Tele‐Health Outcomes in Multiyear Extensions of Parkinson’s Disease trials (AT‐HOME PD), a two‐year virtual cohort study. After providing electronic informed consent, individuals complete annual video visits with a movement disorder specialist, smartphone‐based assessments of motor function and socialization, and patient‐reported outcomes online. Results From the two clinical trials, 226 individuals from 42 states in the United States and Canada enrolled. Of these, 181 (80%) have successfully downloaded the study’s smartphone application and 161 (71%) have completed patient‐reported outcomes on the online platform. Interpretation It is feasible to conduct a large‐scale, international virtual observational study following the completion of participation in brick‐and‐mortar clinical trials in Parkinson’s disease. This study, which brings research to participants, will compare established clinical endpoints with novel digital biomarkers and thereby inform the longitudinal follow‐up of clinical trial participants and design of future clinical trials.

Abstract Lewy body dementia (LBD), including dementia with Lewy bodies and Parkinson’s disease dementia, affects over a million people in the USA and has a substantial impact on patients, caregivers, and society. Symptomatic treatments for LBD, which can include cognitive, neuropsychiatric, autonomic, sleep, and motor features, are limited with only two drugs (cholinesterase inhibitors) currently approved by regulatory agencies for dementia in LBD. Clinical trials represent a top research priority, but there are many challenges in the development and implementation of trials in LBD. To address these issues and advance the field of clinical trials in the LBDs, the Lewy Body Dementia Association formed an Industry Advisory Council (LBDA IAC), in addition to its Research Center of Excellence program. The LBDA IAC comprises a diverse and collaborative group of experts from academic medical centers, pharmaceutical industries, and the patient advocacy foundation. The inaugural LBDA IAC meeting, held in June 2019, aimed to bring together this group, along with representatives from regulatory agencies, to address the topic of optimizing the landscape of LBD clinical trials. This review highlights the formation of the LBDA IAC, current state of LBD clinical trials, and challenges and opportunities in the field regarding trial design, study populations, diagnostic criteria, and biomarker utilization. Current gaps include a lack of standardized clinical assessment tools and evidence-based management strategies for LBD as well as difficulty and controversy in diagnosing LBD. Challenges in LBD clinical trials include the heterogeneity of LBD pathology and symptomatology, limited understanding of the trajectory of LBD cognitive and core features, absence of LBD-specific outcome measures, and lack of established standardized biologic, imaging, or genetic biomarkers that may inform study design. Demands of study participation (e.g., travel, duration, and frequency of study visits) may also pose challenges and impact trial enrollment, retention, and outcomes. There are opportunities to improve the landscape of LBD clinical trials by harmonizing clinical assessments and biomarkers across cohorts and research studies, developing and validating outcome measures in LBD, engaging the patient community to assess research needs and priorities, and incorporating biomarker and genotype profiling in study design.

This article reports the effects of a 2-year supplemental reading program for students in kindergarten through third grade that focused on the development of decoding skills and reading fluency. Two hundred ninety-nine students were identified for participation and were randomly assigned to the supplemental instruction or to a no-treatment control group. Participants' reading ability was assessed in the fall, before the first year of the intervention, and again in the spring of Years 1, 2, 3, and 4. At the end of the 2-year intervention, students who received the supplemental instruction performed significantly better than their matched controls on measures of entry-level reading skills (i.e., letter?word identification and word attack), oral reading fluency, vocabulary, and comprehension. The benefits of the instruction were still clear 2 years after instruction had ended, with students in the supplemental instruction condition still showing significantly greater growth on the measure of oral reading fluency. Hispanic students benefited from the supplemental reading instruction in English as much as or more than non-Hispanic students. Results support the value of supplemental instruction focused on the development of word recognition skills for helping students at risk for reading failure.

Teachers' psychological well-being is important for teachers and students, but teaching is highly stressful, particularly in special education. We examined the role of experiential avoidance (EA) in the well-being of 529 middle and elementary school teachers. EA involves the tendency to avoid thoughts, feelings, and other internal experiences, even when doing so causes long-range consequences. Using a teacher-specific measure, we investigated EA's relationship to stress associated with student misbehavior and limited social support. We also assessed EA's relationship to burnout and depression, finding EA significantly and moderately correlated with depression and all scales of Maslach's Burnout Inventory. Mediation analyses showed EA mediated the relationship between stress associated with student behavior and measures of well-being. We found 26.8% of teachers to be mildly, 8.9% moderately, and 2.8% moderately severely or severely depressed. This evidence concurs with studies showing the value of mindfulness-based interventions and points to the utility of implementing interventions aimed at decreasing EA in teachers.

In this article, the authors describe activities that can keep math and science skills sharp over summer breaks. A fourth-grade class was encouraged to talk about their coming summer break. The class brainstormed about what one might see on the road--"Observing landscapes, vehicles, and highway signage were quick replies." The children were then directed to possibly the most common element on the road: license plates. Every vehicle is required to have one. Each student received a color copy of a car's state plate, all of which were unique. The opportunity to "play" with the digits on their license plates proved to be an excellent opener and provided the chance for students to work together while investigating their individual plates. Using communication via journaling, students could describe a recent trip or one they hope to take. How far did they travel? How much gas did they use? How much did it cost? What kind of mileage did their car get? Additionally, students could explore various terrains as they trace their trip on a map, and science can be incorporated, because climate and weather play an important role in any excursion. What destinations have class members visited? How many students have been to countries outside the United States? Exploring any or all of these topics could lead to rich dialogue and mathematical or science applications.

High stress and burnout are common for early childhood special educators, contributing to high rates of attrition, diminished educational effectiveness, and high turnover. Acceptance and Commitment Therapy (ACT) is a promising approach for the prevention and treatment of a wide variety of problems. Using a randomized wait-list control design, this pilot study evaluated whether ACT workshops delivered to preschool teachers who serve children with developmental disabilities would improve stress-related problems of teachers (i.e., stress, depression, and burnout) and increase collegial support. At pretest, measures of "experiential avoidance" (EA) and "mindful awareness" (MA) showed significant relationships to reports of depression, stress, and burnout. The intervention reduced staff members' EA, increased teachers' MA and "valued living" (VL), and improved teachers' sense of efficacy. This suggests that ACT workshops can help influence factors affecting depression, stress, and burnout in an early childhood special education setting. (Contains 6 tables and 1 figure.)

Background Huntington disease is a fatal, autosomal dominant, neurodegenerative disorder manifest by the triad of a movement disorder, behavioral disturbances, and dementia. At present, no curative or disease modifying therapies exist for the condition and current treatments are symptomatic. Palliative care is an approach to care that focuses on symptom relief, patient and caregiver support, and end of life care. There is increasing evidence of the benefit of palliative care throughout the course of neurodegenerative conditions including Parkinson disease and amyotrophic lateral sclerosis. However, beyond its application at the end of life, little is known about the role of palliative care in Huntington disease.Methods In this article, we discuss what is known about palliative care in Huntington disease, specifically related to early disease burden, caregiver burnout, advance care planning, and end of life care.Results We provide a review of the current literature and discuss our own care practices.Discussion We conclude by discussing questions that remain unanswered and positing ideas for future work in the field.