Trial of Cinpanemab in Early Parkinson's Disease.

BACKGROUND: Aggregated α-synuclein plays an important role in Parkinson's disease pathogenesis. Cinpanemab, a human-derived monoclonal antibody that binds to α-synuclein, is being evaluated as a disease-modifying treatment for Parkinson's disease. METHODS: In a 52-week, multicenter, double-blind, phase 2 trial, we randomly assigned, in a 2:1:2:2 ratio, participants with early Parkinson's disease to receive intravenous infusions of placebo (control) or cinpanemab at a dose of 250 mg, 1250 mg, or 3500 mg every 4 weeks, followed by an active-treatment dose-blinded extension period for up to 112 weeks. The primary end points were the changes from baseline in the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score (range, 0 to 236, with higher scores indicating worse performance) at weeks 52 and 72. Secondary end points included MDS-UPDRS subscale scores and striatal binding as assessed on dopamine transporter single-photon-emission computed tomography (DaT-SPECT). RESULTS: Of the 357 enrolled participants, 100 were assigned to the control group, 55 to the 250-mg cinpanemab group, 102 to the 1250-mg group, and 100 to the 3500-mg group. The trial was stopped after the week 72 interim analysis owing to lack of efficacy. The change to week 52 in the MDS-UPDRS score was 10.8 points in the control group, 10.5 points in the 250-mg group, 11.3 points in the 1250-mg group, and 10.9 points in the 3500-mg group (adjusted mean difference vs. control, -0.3 points [95% confidence interval {CI}, -4.9 to 4.3], P = 0.90; 0.5 points [95% CI, -3.3 to 4.3], P = 0.80; and 0.1 point [95% CI, -3.8 to 4.0], P = 0.97, respectively). The adjusted mean difference at 72 weeks between participants who received cinpanemab through 72 weeks and the pooled group of those who started cinpanemab at 52 weeks was -0.9 points (95% CI, -5.6 to 3.8) for the 250-mg dose, 0.6 points (95% CI, -3.3 to 4.4) for the 1250-mg dose, and -0.8 points (95% CI, -4.6 to 3.0) for the 3500-mg dose. Results for secondary end points were similar to those for the primary end points. DaT-SPECT imaging at week 52 showed no differences between the control group and any cinpanemab group. The most common adverse events with cinpanemab were headache, nasopharyngitis, and falls. CONCLUSIONS: In participants with early Parkinson's disease, the effects of cinpanemab on clinical measures of disease progression and changes in DaT-SPECT imaging did not differ from those of placebo over a 52-week period. (Funded by Biogen; SPARK ClinicalTrials.gov number, NCT03318523.).

Perceptions of COVID-19 self-testing and recommendations for implementation and scale-up among Black/African Americans: implications for the COVID-19 STEP project.

BACKGROUND: COVID-19 self-testing (ST) is an innovative strategy with the potential to increase the access and uptake of testing and ultimately to limit the spread of the virus. To maximize the uptake and reach of this promising strategy and inform intervention development and scale up, research is needed to understand the acceptability of and willingness to use this tool. This is vital to ensure that Black/African Americans are reached by the Biden-Harris Administration's free national COVID-19 ST program. This study aimed to explore the acceptability and recommendations to promote and scale-up the uptake of COVID-19 ST among Black/African Americans. METHODS: We conducted a cross-sectional qualitative study using a semi-structured questionnaire to assess barriers and facilitators to the uptake of COVID-19 ST among a convenience sample of 28 self-identified Black/African Americans from schools, community centers, and faith-based institutions in Ohio and Maryland. Inductive content analysis was conducted to identify categories and subcategories related to acceptability and recommendations for implementing and scaling up COVID-19 ST in communities. RESULTS: Participants perceived COVID-19 self-testing as an acceptable tool that is beneficial to prevent transmission and address some of the barriers associated with health facility testing, such as transportation cost and human contact at the health facility. However, concerns were raised regarding the accurate use of the kits and costs. Recommendations for implementing and scaling up COVID-19 ST included engagement of community stakeholders to disseminate information about COVID-19 self-testing and creating culturally appropriate education tools to promote knowledge of and clear instructions about how to properly use COVID-19 ST kits. Based on these recommendations, the COVID-19 STEP (Self-Testing Education and Promotion) Project is being developed and will involve engaging community partners such as barbers, church leaders, and other community-based organizations to increase the uptake and use of free COVID-19 ST kits among Black/African Americans. CONCLUSION: Findings showed that most participants considered COVID-19 ST valuable for encouraging COVID-19 testing. However, cost and accuracy concerns may pose barriers. Future work should consider implementing interventions that leverage the benefits of COVID-19 ST and further assess the extent to which these identified facilitators and barriers may influence COVID-19 ST uptake.

Rapid Telehealth Implementation during the COVID-19 Global Pandemic: A Rapid Review.

The implementation and continued expansion of telehealth services assists a variety of health care organizations in the delivery of care during the current COVID-19 global pandemic. However, limited research has been conducted on recent, rapid telehealth implementation and expansion initiatives regarding facilitators and barriers surrounding the provision of quality patient care. Our rapid review evaluated the literature specific to rapid telehealth implementation during the current COVID-19 pandemic from three research databases between January 2020 and May 2020 and reported using preferred reporting items for systematic reviews and meta-analyses (PRISMA). The results indicate the rapid implementation and enhanced use of telehealth during the COVID-19 pandemic in the United States surrounding the facilitators and barriers to the provision of patient care, which are categorized into three identified themes: (1) descriptive process-oriented implementations, (2) the interpretation and infusion of the CARES Act of 2020 telehealth exemptions related to the relaxation of patient privacy and security (HIPAA) protocols, and (3) the standard of care protocols and experiences addressing organizational liability and the standard of care. While the study limitation of sample size exists (n = 21), an identification of rapid telehealth implementation advancements and challenges during the current pandemic may assist health care organizations in the delivery of ongoing quality care during the COVID-19 pandemic.