Alzheimer''s and Dementia: Translational Research and Clinical Interventions最新文献

{"title":"The importance of the dyad: Participant perspectives on sharing biomarker results in Alzheimer's disease research","authors":"Fred B. Ketchum,&nbsp;Nathaniel A. Chin,&nbsp;Claire Erickson,&nbsp;Nickolas H. Lambrou,&nbsp;Kristin Basche,&nbsp;Carey E. Gleason,&nbsp;Lindsay Clark","doi":"10.1002/trc2.12416","DOIUrl":"10.1002/trc2.12416","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> BACKGROUND</h3>\u0000 \u0000 <p>In the asymptomatic “preclinical” phase of Alzheimer's disease (AD), abnormal biomarkers indicate risk for developing cognitive impairment. Biomarker information is increasingly being disclosed to participants in research settings, and biomarker testing and results disclosure will be implemented in clinical settings in the future. Biomarker disclosure has potential psychosocial benefits and harms, impacting affected individuals and their support person(s). Limited data are available about with whom research participants share their results, information that will be necessary to develop disclosure protocols and post-disclosure resources. Additionally, existing research has been conducted in largely White cohorts, limiting applicability to future clinical populations.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> METHODS</h3>\u0000 \u0000 <p>We enrolled a diverse cohort of 329 adults (184 non-Hispanic White and 145 Black/African American individuals) who previously participated in AD research. After reviewing a vignette describing a hypothetical biomarker research study, participants indicated their anticipated willingness to share biomarker results with loved ones, and what reactions they anticipated from others. Using mixed-methods analysis, we identified responses related to willingness to share results.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> RESULTS</h3>\u0000 \u0000 <p>A majority (78.7%) were willing to share their results with support persons. Many (59.6%) felt it would not be difficult to share, and most (90.6%) believed their loved ones would be supportive. The most common reasons for sharing were to prepare for possible future AD (41.0% of respondents), while the most common reason for not sharing was to avoid worrying loved ones (4.8% of respondents). A total of 7.3% of respondents related reasons regarding being unsure about sharing.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> DISCUSSION</h3>\u0000 \u0000 <p>Participants’ interest in sharing results supports integrating support persons into AD biomarker research, and may help maximize potential benefits for participants. Communicating with this \"dyad\" of research participant and support person(s) may improve involvement in research, and help prepare for implementation of clinical biomarker testing by clarifying communication preferences and the influence of support persons on psychosocial outcomes.</p>\u0000 </section>\u0000 </div>","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2023-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/08/8d/TRC2-9-e12416.PMC10423755.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10012660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient-related benefits of amyloid PET imaging in dementia: Rationale and design of the German randomized coverage with evidence development study ENABLE","authors":"Stefan J. Teipel,&nbsp;Annika Spottke,&nbsp;Henning Boecker,&nbsp;Marcel Daamen,&nbsp;Erika Graf,&nbsp;Jörg Sahlmann,&nbsp;Ralph Buchert,&nbsp;Wolfgang Mohnike,&nbsp;Konrad Mohnike,&nbsp;Jens Kurth,&nbsp;Frank Jessen,&nbsp;Bernd J. Krause","doi":"10.1002/trc2.12383","DOIUrl":"10.1002/trc2.12383","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <p>The utility of amyloid positron emission tomography (PET) for the etiological diagnosis of dementia and its impact on functional status of patients in routine care are currently unclear. Here, we describe the design of ENABLE, a randomized controlled two-armed coverage with evidence development (CED) study in Germany. Approximately 1126 patients with mild to moderate dementia of unclear etiology will be randomly assigned to either an amyloid PET or a no amyloid PET group. Patients will be followed-up for 24 months. The study has been registered at the German Clinical Trials Register (https://drks.de/search/de/trial/DRKS00030839) with the registration code DRKS00030839. The primary endpoint of ENABLE is the ability to perform functional activities of daily living at 18 months. Secondary endpoints include change in diagnosis, diagnostic confidence, and cognitive and clinical outcomes of patients. We expect that the CED study ENABLE will inform about patient relevant effects of amyloid PET in routine care. Furthermore, we anticipate that ENABLE will support physicians’ and payers’ decisions on provision of health care for patients with dementia.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Highlights</h3>\u0000 \u0000 <div>\u0000 <ul>\u0000 \u0000 <li>Study design focuses on the usefulness of amyloid positron emission tomography (PET) in routine care.</li>\u0000 \u0000 <li>Study design addresses the patient-relevant effect of amyloid PET.</li>\u0000 \u0000 <li>Patient representatives were involved in the creation of the study design.</li>\u0000 \u0000 <li>The study will help improve routine care for people with dementia.</li>\u0000 </ul>\u0000 </div>\u0000 </section>\u0000 </div>","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2023-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/21/80/TRC2-9-e12383.PMC10407881.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10326428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An integrative review of measures of transitions and care coordination for persons living with dementia and their caregivers","authors":"Karen B. Hirschman,&nbsp;Molly McHugh,&nbsp;Brianna Morgan","doi":"10.1002/trc2.12391","DOIUrl":"10.1002/trc2.12391","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>High rates of hospital visits and readmissions are common among persons living with dementia, resulting in frequent transitions in care and care coordination. This paper identifies and evaluates existing measures of transitions and care coordination for persons living with dementia and their caregivers.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This integrative review builds off a prior review using a systematic search of online databases (PubMed, EBSCO, CINAHL, PsycInfo, and Scopus) to identify records and locate reports (or articles) that use measures of care transitions and care coordination. Identified measures were compared to the Alzheimer's Association's Dementia Care Practice Recommendations to evaluate strengths and weaknesses of the measure in this population, such as if measures were person- and family-centered.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Seventy-one reports using measures of transitions in care and care coordination for persons living with dementia and their caregivers were identified. There were multiple measures identified in some reports. Three main areas of measures were classified into: identification of the population (3 measures, 8 reports), transitional care and care coordination delivery (14 measures, 17 reports), and transitional care and care coordination outcomes (e.g., health-care use, cost, and mortality; 17 measures, 60 reports). A strength of the three main areas of measures was that a portion of the measures were person- and family-centered. Variability in the operational definitions of some measures and time intensiveness of collecting the measure (e.g., number of items, the time it takes to complete the items) were common weaknesses.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>Transitions and care coordination measures are varied across studies targeted at persons living with dementia and their caregivers. Existing measures focus heavily on outcomes, specifically health-care resource use, and cost, rather than the elements of transitional care or care coordination. Future measure development focused on care transitions and service coordination is needed.</p>\u0000 </section>\u0000 </div>","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2023-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/3c/93/TRC2-9-e12391.PMC10404587.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9956782","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of methylphenidate on neuropsychiatric symptoms in Alzheimer's disease: Evidence from the ADMET 2 study","authors":"Emily D. Clark,&nbsp;Jamie Perin,&nbsp;Nathan Herrmann,&nbsp;Olga Brawman-Mintzer,&nbsp;Krista L. Lanctôt,&nbsp;Alan J. Lerner,&nbsp;Jacobo Mintzer,&nbsp;Prasad R. Padala,&nbsp;Paul B. Rosenberg,&nbsp;Susie Sami,&nbsp;David M. Shade,&nbsp;Christopher H. van Dyck,&nbsp;Anton P. Porsteinsson,&nbsp;for the ADMET-2 Study Group","doi":"10.1002/trc2.12403","DOIUrl":"10.1002/trc2.12403","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> INTRODUCTION</h3>\u0000 \u0000 <p>Methylphenidate has been shown to improve apathy in patients with Alzheimer's disease (AD). The authors evaluated the impact of methylphenidate on neuropsychiatric symptoms (NPS) of AD, excluding apathy, using data from the Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) study.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> METHODS</h3>\u0000 \u0000 <p>A secondary analysis was conducted on data from the ADMET 2 study to determine the effect of methylphenidate on Neuropsychiatric Inventory (NPI) scores outside of apathy. Caregiver scores were compared from baseline to month 6 in 199 participants receiving methylphenidate (20 mg/day) or placebo regarding the presence or absence of individual neuropsychiatric symptoms, emergence of new symptoms, and individual domain scores.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> RESULTS</h3>\u0000 \u0000 <p>No clinically meaningful improvement was observed in any NPI domain, excluding apathy, in participants treated with methylphenidate compared to placebo after 6 months. A statistical difference between groups was appreciated in the domains of elation/euphoria (<i>P</i> = 0.044) and appetite/eating disorders (<i>P</i> = 0.014); however, these findings were not considered significant.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> DISCUSSION</h3>\u0000 \u0000 <p>Methylphenidate is a selective agent for symptoms of apathy in patients with AD with no meaningful impact on other NPS. Findings from this secondary analysis are considered exploratory and multiple limitations should be considered when interpreting these results, including small sample size and use of a single questionnaire.</p>\u0000 \u0000 <section>\u0000 \u0000 <h3> HIGHLIGHTS</h3>\u0000 \u0000 <div>\u0000 <ul>\u0000 \u0000 <li>Methylphenidate was not associated with significant improvement on the Neuropsychiatric Inventory in domains outside of apathy.</li>\u0000 \u0000 <li>Methylphenidate did not show a statistically significant emergence of new neuropsychiatric symptoms (NPS) throughout the 6-month treatment period compared to placebo.</li>\u0000 \u0000 <li>Methylphenidate appears to be a highly selective agent for apathy in Alzheimer's disease, potentially supporting catecholaminergic dysfunction as the driving force behind this presentation of symptoms.</li>\u0000 </ul>\u0000 </div>\u0000 </section>\u0000 </section>\u0000 </div>","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2023-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/bf/b7/TRC2-9-e12403.PMC10394740.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9992847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dementia care navigation: Building toward a common definition, key principles, and outcomes","authors":"Beth A. Kallmyer,&nbsp;David Bass,&nbsp;Matthew Baumgart,&nbsp;Christopher M. Callahan,&nbsp;Sarah Dulaney,&nbsp;Leslie C. Evertson,&nbsp;Sam Fazio,&nbsp;Katherine S. Judge,&nbsp;Quincy Samus","doi":"10.1002/trc2.12408","DOIUrl":"10.1002/trc2.12408","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> INTRODUCTION</h3>\u0000 \u0000 <p>As the complexity of medical treatments and patient care systems have increased, the concept of patient navigation is growing in both popularity and breadth of application. Patient navigators are trained personnel whose role is not to provide clinical care, but to partner with patients to help them identify their needs and goals and then overcome modifiable patient-, provider-, and systems-level barriers. Due to its high incidence, duration, and medical–social complexity, dementia is an ideal candidate for a patient-centric health care delivery model such as care navigation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> METHODS</h3>\u0000 \u0000 <p>The Alzheimer's Association formed an expert workgroup of researchers in the field of dementia care navigation to identify evidence-based guidelines.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> RESULTS</h3>\u0000 \u0000 <p>Recognizing the unique and challenging needs of persons living with dementia and their care partners, several U.S. dementia care navigation programs have been developed and assessed in recent years. Collectively these programs demonstrate that persons living with dementia and their care partners benefit from dementia care navigation. Improved care system outcomes for the person living with dementia include reduced emergency department visits, lower hospital readmissions, fewer days hospitalized, and shorter delays in long-term care placement. Well-being is also increased, as there is decreased depression, illness, strain, embarrassment, and behavioral symptoms and increased self-reported quality of life. For care partners, dementia navigation resulted in decreased depression, burden, and unmet needs.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> DISCUSSION</h3>\u0000 \u0000 <p>This article presents principles of dementia care navigation to inform existing and emerging dementia care navigation programs.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Highlights</h3>\u0000 \u0000 <div>\u0000 <ul>\u0000 \u0000 <li>Several U.S. dementia care navigation programs have demonstrated outcomes for persons living with dementia, care partners, and health systems.</li>\u0000 \u0000 <li>The Alzheimer's Association formed an expert workgroup of researchers in the field of dementia care navigation to create a shared definition and identify evidence-based guidelines or principles.</li>\u0000 \u0000 <li>These outlined principles of dementia care navigation can inform existing","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/51/63/TRC2-9-e12408.PMC10392594.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10290009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility of virtual Alzheimer's biomarker disclosure: Findings from an observational cohort","authors":"Claire M. Erickson,&nbsp;Nathaniel A. Chin,&nbsp;Hannah L. Rosario,&nbsp;Amanda Peterson,&nbsp;Sterling C. Johnson,&nbsp;Lindsay R. Clark","doi":"10.1002/trc2.12413","DOIUrl":"10.1002/trc2.12413","url":null,"abstract":"Increased availability of Alzheimer's disease (AD) biomarker tests provides older adults with opportunities to seek out and learn results. We evaluated the feasibility of virtually returning AD biomarker results.","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2023-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d4/3e/TRC2-9-e12413.PMC10382796.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9901487","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Meaningful benefit and minimal clinically important difference (MCID) in Alzheimer's disease: Open peer commentary","authors":"Jeffrey Cummings","doi":"10.1002/trc2.12411","DOIUrl":"10.1002/trc2.12411","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Approval of the anti-amyloid monoclonal antibodies has stimulated an important discussion of the value to be placed on the magnitude of slowing achieved by treatment compared to placebo.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The minimal clinically important difference (MCID) was reviewed in the context of other measures and analyses that provide perspective on the meaningfulness of treatment responses.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>TheMCID is a clinician-anchored approach to making this determination. The MCID applies best to symptomatic therapies for which the drug–placebo difference remains constant. Disease-modifying therapies produce a progressive divergence of drug and placebo trajectories; early in the course the MCID would not be achieved, later the MCID will be achieved, and with continuing therapy the MCID will be exceeded. Clinicians are not the only stakeholders involved in determining the value proposition of slowing disease progression. Patient-reported outcomes and caregiver-related measures offer important complementary insights. Analytic approaches also widen the perspective on the observed drug–placebo differences. Risk ratios, numbers needed to treat versus number needed to harm, time-to-event analyses, and predictive benefits based on biomarkers all add depth to the discussion.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>Multiple stakeholder perspectives are needed to determine the importance to be attributed to the therapeutic changes observed with monoclonal antibody therapies and other emerging treatments.</p>\u0000 </section>\u0000 </div>","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2023-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/14/59/TRC2-9-e12411.PMC10372384.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10028358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erratum to “A call to address structural barriers to Hispanic/Latino representation in clinical trials on Alzheimer's disease and related dementias: A micro-meso-macro perspective”","authors":"","doi":"10.1002/trc2.12409","DOIUrl":"10.1002/trc2.12409","url":null,"abstract":"<p>In the paper by Aranda, MP et al. (A call to address structural barriers to Hispanic/Latino representation in clinical trials on Alzheimer's disease and related dementias: A micro-meso-macro perspective. Alzheimer's Dement. 2023; 9:e12389. https://doi.org/10.1002/trc2.12389), an error occurred in the preparation of the paper for publication, requiring the following corrections.</p><p>In the initial publication of this article, the last author's name is misspelled. Elena Portacolonem should be Elena Portacolone.</p><p>Additionally, under section 8.1, “specify goals for enrollment of underrepresented racial and ethnical participants” should be “specify goals for enrollment of underrepresented racial and ethnic participants”.</p><p>The authors regret the errors.</p>","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2023-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2e/09/TRC2-9-e12409.PMC10357416.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9918453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Discussing inconvenient truths about the lack of generalizability of Alzheimer's research to minoritized populations","authors":"Stephanie J. Monroe","doi":"10.1002/trc2.12406","DOIUrl":"10.1002/trc2.12406","url":null,"abstract":"<p>The U.S. Food and Drug Administration (FDA) hopes to achieve greater racial and ethnic diversity in clinical trials, which is urgently needed.<span>¹</span> As S&amp;P Market Intelligence noted, “The U.S. Food and Drug Administration [FDA] approved a record 59 new therapies in 2018, but among the 53 drugs with U.S. clinical trials, only 12 had enough data to provide some knowledge of the drug's effects across races, the FDA's Drug Trials Snapshots reported. Among these limited records, the majority of participants were white”<span>²</span></p><p>Many believe the FDA did its job in approving Aduhelm (aducanumab) with data from 1% Black and 3% Hispanic trial participants, and lecanemab (marketed as Leqembi) with 4% Black and 18% Hispanic participants.</p><p>Many of us living with the disease or working to end it are thrilled that for the first time in 17 years, two disease-modifying therapies for Alzheimer's disease have received accelerated approval, with one (lecanemab) recently receiving full approval. But did we really do our job? Does use of limited, ungeneralizable data provide confidence as to the safety and effectiveness of drugs in marginalized populations. The scientists at FDA say yes and we have to respect that, but patients and their doctors especially of those from marginalized and communities historically excluded from clinical trials will utilimately be the decision-makers which is appropriate.</p><p>With the U.S. population being 59.3% White alone (not Hispanic or Latino), and 47.3%<span>³</span> from minoritized/non-White populations, should we as scientists, researchers, patients, and advocates unquestionably embrace approvals based on data gathered from trial populations that are between 75%-97% White, with Black—non-generalizable data—in the single digits? Should we disregard current population shifts and high disparate prevalence rates among Blacks and Latinos who are at least twice as likely (Black/African Americans) or 1.5x as likely (Hispanic/Latinos) as Whites to develop Alzheimer's disease.<span>⁴</span></p><p>As a health equity advocate and a person whose father is living with Alzheimer's disease, I find it challenging to applaud a process that tolerates new drugs and therapies being approved based on populations that are not only unrepresentative of the diversity of the U.S. population but also ignores the data pointing to the disparate prevalence of this disease in minority populations.</p><p>As scientists, researchers, patients, and advocates, I believe we have the right to expect, and demand, open, honest, and thorough discussion about the data and what it says and does not say. And as experts, we should be not only be welcoming of those conversations but leaders of them—demonstrating intolerance of attempts to shame, dismiss, or invalidate the scientifically based views of others that happen to be inconvenient from our personal or professional perspectives.</p><p>Scienc","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2023-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/b5/cf/TRC2-9-e12406.PMC10333720.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10193275","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Barriers and solutions to Alzheimer's disease clinical trial participation for Black Americans","authors":"Jordan Savold,&nbsp;Michele Cole,&nbsp;Roland J. Thorpe Jr.","doi":"10.1002/trc2.12402","DOIUrl":"10.1002/trc2.12402","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Black Americans are disproportionately burdened by Alzheimer's disease (AD) relative to other racial groups in the United States and continue to be underrepresented in AD clinical trials. This review explores the primary barriers for participation in clinical trials among Black Americans and provides literature-based recommendations to improve the inclusion of Black Americans in AD clinical trials.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We searched electronic databases and gray literature for articles published in the United States through January 1, 2023, ultimately identifying 26 key articles for inclusion.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Barriers to participation in clinical trials for Black Americans are rooted in social determinants of health, including access to quality education and information, access to health care, economic stability, built environment, and community context. Best practices to improve the inclusion of Black Americans in clinical trials require pharmaceutical companies to adopt a multifaceted approach, investing in innovative strategies for site selection, development of local partnerships, outreach, and education.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>While multisectoral action must occur to effectively address the disproportionate burden of AD on Black Americans, the pharmaceutical industry has an important part to play in this space due to their central role in product development and clinical trials.</p>\u0000 </section>\u0000 </div>","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2023-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4f/fe/TRC2-9-e12402.PMC10318422.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10161631","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}