A Virtual Photovoice Study of Older African Americans Perceptions of Neurovascular Clinical Trials.

BACKGROUND: Alzheimer disease (AD) poses a major public health crisis, especially among African Americans (AAs) who are up to 3 times more likely to develop AD compared with non-Hispanic Whites. Moreover, cardiovascular risk factors represent a precursor to cognitive decline, which contributes to racial/ethnic disparities seen within AD. Despite these disparities, AAs are underrepresented in neurovascular research. The purpose of this qualitative virtual photovoice project is to explore how older Midwestern AAs perceive neurovascular clinical trials. METHODS: Five photovoice sessions were held virtually over a 3-month period. Participants took photos each week that captured the salient features of their environment that described their perceptions and experiences related to neurovascular clinical trials. Structured discussion using the SHOWED method was used to generate new understandings about the perspectives and experiences in neurovascular clinical trials. Data was analyzed using strategies in participatory visual research. RESULTS: A total of 10 AAs aged 55 years and older participated and a total of 6 themes emerged from the photovoice group discussions. CONCLUSION: Findings from this study inform the development of culturally appropriate research protocols and effective recruitment strategies to enhance participation among older AAs in neurovascular clinical trials.

Effectiveness of non-pharmaceutical interventions on cognitive function among non-demented African American and Latino older adults in the USA: a scoping review.

OBJECTIVE: African Americans and Latinos/Hispanics have a higher prevalence of dementia compared to non-Latino Whites. This scoping review aims to synthesize non-pharmaceutical interventions to delay or slow age-related cognitive decline among cognitively healthy African American and Latino older adults. DESIGN: A literature search for articles published between January 2000 and May 2019 was performed using the databases PubMed, CINAHL, PsycINFO and Web of Science. Relevant cited references and grey literature were also reviewed. Four independent reviewers evaluated 1,181 abstracts, and full-article screening was subsequently performed for 145 articles. The scoping review consisted of eight studies, which were evaluated according to the peer-reviewed original manuscript, non-pharmaceutical intervention, cognitive function as an outcome, separate reporting of results for African American and Latinos, minimum age of 40, and conducted in the US. A total of 8 studies were considered eligible and were analyzed in the present scoping review. RESULTS: Eight studies were identified. Four studies focused on African Americans and four focused on Latinos. Through the analysis, results indicated cognitive training-focused interventions were effective in improving memory, executive function, reasoning, visuospatial, psychological function, and speed among African Americans. Exercise interventions were effective in improving cognition among Latinos. CONCLUSION: This scoping review identified effective non-pharmaceutical interventions among African American and Latinos. Effective interventions focused on cognitive training alone for African Americans and exercise combined with group educational sessions for Latinos. Future research should explore developing culturally appropriate non-pharmaceutical interventions to reduce disparities and to enhance cognition among older African American and Latinos.

A retrospective analysis of serious adverse events and deaths in U.S.-based lifestyle clinical trials for cognitive health.

Objective: This retrospective analysis examined serious adverse events (SAEs) and deaths in U.S. lifestyle clinical trials aimed at enhancing cognitive health in older adults. Methods: Data was gathered from trials completed between January 1, 2000, and July 19, 2023, via ClinicalTrials.gov's API. Results: Among these trials, 76% did not report results. The remaining studies fell into four intervention categories: Cognitive/Behavioral, Exercise/Movement, Diet/Supplement, and Multi-modal. When considering all trial types collectively, the findings suggest that lifestyle clinical trials are generally safe. There was no significant increase in the relative risk of experiencing an SAE in the intervention group compared to the control group. However, in terms of relative risk of death, an increase of 28% was observed in the intervention compared to the control, which was statistically significant (X2 (1, N = 36), p < 0.00688). Nevertheless, this increase did not surpass age-adjusted U.S. mortality rates. Assessing the data by intervention type, Diet/Supplement, and Multi-modal trials displayed an elevated relative risk of SAEs in the intervention. Diet/Supplement trials had a 16% increase (X2 (1, N = 2), p < 0.0263), and Multi-modal trials had a 365% increase (X2 (1, N = 5), p < 0.000213). Diet/Supplement trials also showed a 67% increased risk of death (X2 (1, N = 2), p < 0.000197). Conclusions: These findings should be cautiously considered due to the low rate of reporting, but underscore the significance of reporting clinical trial results, enhancing transparency, and facilitating more accurate safety assessments in cognitive aging and lifestyle interventions for older adults.

Using Focus Groups to Explore Older Black Men's Perception of Dietary Interventions.

Older Black men are underrepresented in research despite being disproportionately affected by Alzheimer's disease (AD) and cardiovascular (CV) risk factors related to AD compared with non-Hispanic Whites. Although dietary interventions have shown promise to reduce modifiable CV risk factors related to AD, Black Americans have lower adherence likely due to lack of cultural considerations. Using a noninterventional convergent parallel mixed-methods approach, this study examined the cultural contexts that inform perceptions of dietary interventions among older Midwestern Black men. All participants completed an online demographic and dietary habit survey prior to focus group discussions. Two focus group discussion sessions were conducted with a total of 10 cognitively normal Black men aged 55 years and older. Survey data were analyzed using a frequency analysis and qualitative data were analyzed using a six-step thematic analysis process. Most men indicated having hypertension (N = 7, 77.8%) and currently not following a dietary eating pattern (N = 8, 88.9%). Emerging themes identified included (1) knowledge of dementia, (2) perceptions of dietary interventions, (3) barriers impacting participation in dietary interventions, and (4) overcoming barriers to engage Black men in dietary interventions. Findings from this study should inform the design of future dietary interventions for AD prevention to enhance participation among older Black men.

A service-oriented approach to clinical trial recruitment for dementia and brain health: Methods and case examples of MyAlliance for Brain Health.

INTRODUCTION: Recruitment of sufficient and diverse participants into clinical research for Alzheimer's disease and related dementias remains a formidable challenge. The primary goal of this manuscript is to provide an overview of an approach to diversifying research recruitment and to provide case examples of several methods for achieving greater diversity in clinical research enrollment. METHODS: The University of Kansas Alzheimer's Disease Research Center (KU ADRC) developed MyAlliance for Brain Health (MyAlliance), a service-oriented recruitment model. MyAlliance comprises a Primary Care Provider Network, a Patient and Family Network, and a Community Organization Network, each delivering tailored value to relevant parties while facilitating research referrals. RESULTS: We review three methods for encouraging increased diversity in clinical research participation. Initial outcomes reveal an increase in underrepresented participants from 17% to 27% in a research registry. Enrollments into studies supported by the research registry experienced a 51% increase in proportion of participants from underrepresented communities. DISCUSSION: MyAlliance shifts power, resources, and knowledge to community advocates, promoting brain health awareness and research participation, and demands substantial financial investment and administrative commitment. MyAlliance offers valuable lessons for building sustainable, community-centered research recruitment infrastructure, emphasizing the importance of localized engagement and cultural understanding. Highlights: MyAlliance led to a significant increase in the representation of underrepresented racial and ethnic groups and individuals from rural areas.The service-oriented approach facilitated long-term community engagement and trust-building, extending partnerships between an academic medical center and community organizations.While effective, MyAlliance required substantial financial investment, with costs including infrastructure development, staff support, partner organization compensation, and promotional activities, underscoring the resource-intensive nature of inclusive research recruitment efforts.

A Retrospective Analysis of Serious Adverse Events and Deaths in US-Based Lifestyle Clinical Trials for Cognitive Health.

This retrospective analysis assessed the serious adverse events and deaths reported in lifestyle clinical trials designed to enhance cognitive health in older adults living in the United States. Data was collected from studies conducted between January 1, 2000, and July 19, 2023, using the ClinicalTrials.gov application programming interface. Our query revealed that 76% of these studies did not report trial results. The remaining studies with reported results were categorized under one of four intervention types: Cognitive/Behavioral, Exercise/Movement, Diet/Supplement, and Multi-modal. When all trial types are considered together, the results indicate that lifestyle clinical trials are safe, with no significant increase in relative risk of experiencing an SAE in an intervention group over a control group. And although the increase in relative risk of death in an intervention group over a control group was significant at 28% (X2 (1, N = 36), p < 0.00688), the probability of death was not higher than the U.S. mortality rates by age. When assessing the data using intervention type, Diet/Supplement trials and Multi-modal trials both had an increase in relative risk of experiencing an SAE in the intervention over the control group, with Diet/Supplement trials at 16% (X2 (1, N = 2), p < 0.0263) and Multi-modal trials at 365% (X2 (1, N = 5), p < 0.000213). The Diet/Supplement trials also had an increased risk of death at 67% (X2 (1, N = 2), p < 0.000197). These results should be taken with careful consideration. Due to such a low reporting rate, the 36 studies included in this analysis do not accurately represent the majority of lifestyle clinical trials conducted in the U.S. This study is valuable in that it highlights the importance of reporting clinical trial results, which will improve transparency in trial results and allow for more accurate assessments of safety in the growing field of cognitive aging and lifestyle interventions for older adults.

An open-source system for efficient clinical trial support: The COMET study experience.

Exercise clinical trials are complex, logistically burdensome, and require a well-coordinated multi-disciplinary approach. Challenges include managing, curating, and reporting on many disparate information sources, while remaining responsive to a variety of stakeholders. The Combined Exercise Trial (COMET, NCT04848038) is a one-year comparison of three exercise modalities delivered in the community. Target enrollment is 280 individuals over 4 years. To support rigorous execution of COMET, the study team has developed a suite of scripts and dashboards to assist study stakeholders in each of their various functions. The result is a highly automated study system that preserves rigor, increases communication, and reduces staff burden. This manuscript describes system considerations and the COMET approach to data management and use, with a goal of encouraging further development and adaptation by other study teams in various fields.

Development of a Culturally Adapted Dietary Intervention to Reduce Alzheimer's Disease Risk among Older Black Adults.

The objective of this study is to identify and understand knowledge and attitudes that influence dietary practices among older Black adults using a community-engaged approach. This is a non-interventional mixed methods study designed to inform the development of an adapted brain-healthy soul food diet intervention. A purposive sampling approach was used to conduct seven semi-structured focus group discussions and an online quantitative survey. In total, 39 participants who self-identified as Black, aged 55 years and older, English speaking, and who were cognitively normal with an AD8 < 2; (25.6% men; 74.4% women) participated in the online survey and one of the seven 60 min virtual focus group discussions (5-7 per focus group). Quantitative frequency data from the online surveys were analyzed using descriptive statistics. Qualitative focus group data were analyzed using a 6-step thematic analysis process. Five themes emerged: dementia awareness; practices shaping food choices and consumption; barriers to eating healthy; instrumental support; and elements of a culturally adapted brain-healthy dietary intervention. Older Black adults perceived an adapted MIND dietary model as the most acceptable with the incorporation of salient cultural characteristics and strategies within both the design and delivery phases.

We Are Our Sister's Keeper: The Experience of Black Female Clergy Responding to Intimate Partner Violence.

Intimate partner violence (IPV) affects all populations, regardless of race, education, or socioeconomic status, but Black women experience higher rates of IPV (43.7%) in comparison with White women (34.6%). Although evidence indicates that faith-based organizations and clergy play key roles in preventing and responding to IPV among Black women, limited research has been conducted in this area, and existing studies have focused on Black male clergy leaders' response to IPV. Using transcendental phenomenology, we interviewed 12 Black female clergy regarding their role as responders to IPV among Black women in their congregation. Each clergy leader participated in a face-to-face interview. Data analysis followed the modified Van Kaam seven-step process. One overarching theme emerged-We Are Our Sister's Keeper, as well as three primary themes: Support Advocate, Spiritual Advisor, and Roadblocked Leader. The themes indicated that Black female clergy respond to the emotional and spiritual needs of Black women despite barriers (e.g., few outside resources, limited support from the Black church). The themes also suggested that clergy lack knowledge and training for responding to IPV. However, Black female clergy are passionate about providing holistic, culturally centered care by bridging the gap between the church and the community to better serve Black women who have experienced IPV. Findings support the importance of incorporating spiritual and emotional healing among this population when providing care and services. Further research is needed to develop interventions, such as a faith-based toolkit that incorporates community resources and guidance to better support Black female clergy leaders' ability to respond to IPV.

Effect of aerobic exercise on amyloid accumulation in preclinical Alzheimer's: A 1-year randomized controlled trial.

BACKGROUND: Our goal was to investigate the role of physical exercise to protect brain health as we age, including the potential to mitigate Alzheimer's-related pathology. We assessed the effect of 52 weeks of a supervised aerobic exercise program on amyloid accumulation, cognitive performance, and brain volume in cognitively normal older adults with elevated and sub-threshold levels of cerebral amyloid as measured by amyloid PET imaging. METHODS AND FINDINGS: This 52-week randomized controlled trial compared the effects of 150 minutes per week of aerobic exercise vs. education control intervention. A total of 117 underactive older adults (mean age 72.9 [7.7]) without evidence of cognitive impairment, with elevated (n = 79) or subthreshold (n = 38) levels of cerebral amyloid were randomized, and 110 participants completed the study. Exercise was conducted with supervision and monitoring by trained exercise specialists. We conducted 18F-AV45 PET imaging of cerebral amyloid and anatomical MRI for whole brain and hippocampal volume at baseline and Week 52 follow-up to index brain health. Neuropsychological tests were conducted at baseline, Week 26, and Week 52 to assess executive function, verbal memory, and visuospatial cognitive domains. Cardiorespiratory fitness testing was performed at baseline and Week 52 to assess response to exercise. The aerobic exercise group significantly improved cardiorespiratory fitness (11% vs. 1% in the control group) but there were no differences in change measures of amyloid, brain volume, or cognitive performance compared to control. CONCLUSIONS: Aerobic exercise was not associated with reduced amyloid accumulation in cognitively normal older adults with cerebral amyloid. In spite of strong systemic cardiorespiratory effects of the intervention, the observed lack of cognitive or brain structure benefits suggests brain benefits of exercise reported in other studies are likely to be related to non-amyloid effects. TRIAL REGISTRATION: NCT02000583; ClinicalTrials.gov.

The IGNITE trial: Participant recruitment lessons prior to SARS-CoV-2.

Full and diverse participant enrollment is critical to the success and generalizability of all large-scale Phase III trials. Recruitment of sufficient participants is among the most significant challenges for many studies. The novel SARS-CoV-2 coronavirus pandemic has further changed and challenged the landscape for clinical trial execution, including screening and randomization. The Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE) study has been designed as the most comprehensive test of aerobic exercise effects on cognition and brain health. Here we assess recruitment into IGNITE prior to the increased infection rates in the United States, and examine new challenges and opportunities for recruitment with a goal of informing the remaining required recruitment as infection containment procedures are lifted. The results may assist the design and implementation of recruitment for future exercise studies, and outline opportunities for study design that are flexible in the face of emerging threats.