Research Articles

This resource provides recommendations for how to engage people living with dementia in all stages of clinical research.

This resource describes barriers to recruiting Latino adults for dementia research during the COVID-19 pandemic, with an emphasis on social isolation.

This community-engaged study identifies barriers and facilitators to clinical research participation for people living with dementia and their caregivers.

This study identifies themes in how older African Americans perceive neurovascular clinical trials.

This review article presents a framework for advance care planning clinical trials that are embedded into existing health care.

This study identifies characteristics of U.S. adults that are associated with the self-reported likelihood to participate in dementia-prevention clinical trials.

This resource describes trends in recruitment over a 20-year period of NIH-funded Alzheimer’s clinical trials.

This article describes how caring behaviors by recruiters impact recruitment in African American and Non-Latinx White older adults.

This resource describes a support program in which dementia caregivers are matched Dementia Ambassadors trained to educate caregivers and provide appropriate referrals.

This article examines barriers and facilitators to the clinical trial recruitment of Mexican and Mexican American people at risk for autosomal dominant Alzheimer’s disease.

This article provides a framework for planning disclosure and consent procedures for research studies involving participants with dementia.

This resource summarizes key insights from the second annual Latinos & Alzheimer’s Symposium.

This resource describes the most effective strategies to increase research participation among older African Americans, based on an analysis of peer-review studies.

This article examines barriers and facilitators to brain donation in a group of Latino adults.

This resource describes barriers and facilitators of dementia care through the lens of African American caregivers in rural Kentucky.

This resource explores different ways clinical researchers adapted their recruitment strategies during the COVID-19 pandemic.

This research article describes how Alzheimer’s disease clinical trial participants view the role of the study partner and how their view informs the selection process.

This article explores Alzheimer’s disease knowledge and perception within a Native American community.

This resource explores how academic health centers can more closely engage with their surrounding communities.

This article describes how considering cultural factors can improve the care and recruitment of people with dementia from underrepresented minority groups.

In this review article, researchers summarize the importance of caring behaviors in the recruitment of older African Americans with chronic illness.

In this review article, researchers discuss the ethical aspects to consider when recruiting people with dementia for clinical trials.

This resource examines how the U.K.-based Join Dementia Research registry strongly bolstered recruitment efforts.

This article explores why and how to incorporate critical race theory into dementia caregiver recruitment efforts.

This resource summarizes the results from focus groups with African American older adults in which they discuss their beliefs about participation in clinical research.

In this article, researchers examine the effectiveness of a community-based strategy to recruit participants for a dementia study.

This article examines how race and ethnic background impacts sources of recruitment and eligibility for an Alzheimer’s preclinical trial.

This study tested the effectiveness of different strategies to improve the clinical trial experiences of hospitalized older adults with dementia and their caregivers.

In this study, researchers examined the perspectives of Asian American and Pacific Islanders regarding their participation in a research recruitment registry.

This review article from NIA provides strategies to increase awareness and participation of Hispanics/Latinos in AD/ADRD clinical research studies.

Using research results, Alzheimer's disease scientists developed materials that communicate information to participants about the risk of developing Alzheimer's.

This article highlights how concentrated community memory screening events can be an effective and efficient recruitment strategy for Alzheimer’s disease research.

Researchers assessed direct-to-consumer APOE genetic testing usage and their attitudes toward using this information in clinical trial recruitment.

This article describes how the University of Pittsburgh’s Alzheimer’s Disease Research Center used research participation stories to create messaging for recruitment materials.

This paper describes the researchers’ experiences in establishing and maintaining a diverse Alzheimer’s Disease Prevention Registry.

A report that overviews the Washington University School of Medicine Knight ADRC's “African American Participation in Alzheimer Disease Research: Effective Strategies” Workshop on research participation.

This research examined the effectiveness and differences in using both traditional and social media materials for the recruitment of African American versus non-Hispanic white participants.

This research article describes the Minority Aging Research Study's brain donation challenges, processes, and successful procurement with older African American adults.

A research article from the Rush Alzheimer’s Disease Research Center helps researchers learn about their participants and procedures to better advance the science of Alzheimer’s and related dementias in Latinxs.

Gene Test or Not? is an online decision-making tool designed to help people decide about whether they should have the APOE genetic test.

This paper describes the development of a standardized approach to disclosing amyloid imaging research results to people with mild cognitive impairment.

The authors developed a document for use with potential study participants that describes the process of amyloid imaging and the implications of amyloid imaging results.

This paper outlines a framework created by the Alzheimer’s Prevention Initiative Genetic Testing, Counseling, and Disclosure Committee for large-scale disclosure of APOE results to study participants.

To test an intervention for increasing Alzheimer’s disease literacy among African Americans, the researchers enrolled 193 African American community-dwelling adults using culturally tailored education and messaging.

Researchers looked at how enrollment factors made a difference, broken out by race, on the progression of mild cognitive impairment and dementia. Using Alzheimer’s Disease Research Center data, they examined the rate of impairment between white participants and Black participants with age-at-progression survival models.

According to the article authors, the ideal participants for Alzheimer's disease clinical trials would show cognitive decline in the absence of treatment (i.e., placebo arm) and also would be responsive to the therapeutic intervention being studied (i.e., drug arm). This investigation tested whether machine learning models can effectively predict cognitive decline in people with mild to moderate Alzheimer’s disease during the timeframe of a phase III clinical trial. Data from 202 participants...

The authors of this integrative review found that passive, indirect recruitment strategies have been the default approach for enrolling older African Americans into chronic illness-related research studies, including Alzheimer's studies. They recommend the use of proactive, culturally appropriate recruitment approaches, combined with caring recruiter behaviors, that explicitly target older African American adults and that involve direct interactions between prospective participants and the...

This article describes a validated two-step process for recruiting asymptomatic amyloid-positive individuals into clinical trials. The process was tested using cohorts from three Alzheimer’s studies (ADNI-MCI, ADNI-CN and INSIGHT). During a pre-screening phase, researchers pre-selected a subset of individuals who were more likely to be amyloid positive, based on the automatic analysis of data acquired during routine clinical practice, before doing a confirmatory PET scan for these selected...

For the Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) trial, 462 new participants were enrolled. Recruitment metrics were recorded on 82,003 unique visitors to the recruitment website and 3,335 calls to study phone numbers. The recruitment sources that produced the most screening and enrollment included online advertisements, local radio and newspaper coverage, and emails and referrals from patient registries. According to the authors, ADNI3 is an example of how a data-driven approach to...

The rarity of disorders caused by frontotemporal lobar degeneration (FTLD) leads to recruitment challenges for related clinical trials and difficulties with adequate power to detect treatment effects. The authors of this systematic review recommend developing personalized endpoints that are most clinically meaningful to individuals and their families, devising more powerful approaches to analyzing heterogeneous clinical and magnetic resonance imaging data, and developing new fluid biomarkers and...

Research participants who intend to donate their brains to a study on Alzheimer’s and related diseases are reliant on family members to fulfill the donation plan. Thus, family members play a pivotal role in increasing brain donation rates, particularly among underrepresented groups. In this study, researchers conducted focus groups with a total of 15 Latino adults who each has a parent age 65 or over. Analysis of the discussions support inclusion of family members during all stages of the...

People with Alzheimer’s disease are vulnerable to therapeutic misconception, particularly, the conflation of routine clinical care and scientific research. This misconception can compromise the informed consent process by causing prospective participants to underappreciate the level of risk involved in trial participation. The authors advocate for a more comprehensive informed consent process that accounts for the uniqueness of Alzheimer’s disease, creates a more productive and clear...

Using the CTSdatabase, a registry with more than 60,000 participants, the study authors found that nearly 4% of participants who were screened for memory loss studies visited more than one site within two years. Potential Alzheimer’s participants who went to additional sites did so predominantly for nonmemory conditions, often major depressive disorder or schizophrenia. According to the study authors, multiple enrollments confound efficacy and safety signals in clinical trials. They speculate...

For this study, 10,450 participants enrolled in an initial cohort study were asked to complete a six-lesson interactive education course, AlzU.org, about Alzheimer’s disease. Participants in the highest lesson completion group demonstrated the greatest screening rates for the Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) trial. In a subsequent randomized-controlled trial, 351 new participants were enrolled in the six-lesson course (n = 180) versus a time-neutral control course...

This systematic review examined 22 published reports describing recruitment and retention of individuals from underrepresented backgrounds in Alzheimer’s disease research or underrepresented participants’ perspectives regarding participation in such research. The authors concluded that considerable scientific gaps limit the use of prior efforts by scientists to bolster inclusion of members from underrepresented groups. They recommend that future studies on this topic use improved methodological...

In this British study, 33 researchers working on dementia trials in care homes completed an online, qualitative questionnaire outlining their experiences and the perceived benefits and challenges of data collection from people with dementia (as opposed to only collecting data from caregivers or family member proxies). Five main benefits from obtaining the direct perspective of people with dementia in research were identified: (1) improving the delivery of person-centered care, (2) hearing the...

Patients with Parkinson's disease face barriers that can make it difficult to travel to clinical trials. These include having dementia, loss of driving ability, timing of medications, impact of reduced mobility, and bowel and bladder concerns. Many of these barriers also affect patients with Alzheimer's disease. In this pilot project, researchers sought to assess the feasibility and effect on research participation of prearranged rides through a third-party ride sharing service for research...

The aim of this study was to explore the feasibility of a 45-minute, culturally tailored presentation on Alzheimer's disease for professionals serving the Latino community and Latinos served by community organizations. Five lunch-and-learn events (“Smart Aging” presented in English to professionals and “Envejecimineto Digno” presented in Spanish to served Latinos) were conducted with a total of 40 professionals and 37 served Latinos. Researchers increased the pool of participants by scheduling...

This article describes the information-gathering process that led to the creation of two educational resources designed specifically for the Hispanic/Latino population, The Precious Gift Brain Donation Brochure and the Brain Donation Steps Handout. In a review of the National Alzheimer’s Coordination Center’s (NACC) database for June 2005–May 2016, the authors found that people who self-identify as Hispanic/Latino made up only 8 percent of participants enrolled and 3 percent of the deceased...

To help increase participation of Hispanic older adults in dementia research, this trial aimed to assess the effectiveness of a culturally tailored recruitment educational strategy for older Hispanic adults. Researchers held six one-session tailored dementia education events at trusted community senior centers. The participants were given contact information to complete if they were interested in dementia research and enrollment into the National Alzheimer’s Coordination Center was tracked...

This article describes the study design of a dual-objective, Phase III clinical trial in individuals presymptomatic for Alzheimer’s disease. It addresses the particular challenges for delay and prevention studies. These include: Ensuring that the trial population, cognitively normal at outset, contains a sufficient number of participants at increased risk of cognitive impairment onset during the trial time frame to avoid prohibitive trial size and duration. Finding appropriate measures to detect...

This article describes the methodology and initial recruitment findings for a study that estimated prevalence of cognitive impairment and dementia in Mexican Americans compared with non-Hispanic white people in Nueces County, Texas. The study was aligned with the parent BASIC project, a population-based epidemiological stroke surveillance project, funded by the National Institutes of Health since 1999 to identify differences in stroke prevalence among Mexican Americans and non-Hispanic Whites...

The authors analyzed the strategies used to recruit participants at three sites in a large, 15-site dementia study in England. They concluded that successful recruitment of people with dementia and their caregivers requires multiple strategies, close coordination between researchers and clinical service providers, and a detailed understanding of the needs and perspectives of the target population. The authors recommend that large studies should be expected to evaluate and report on their...

The article addresses ways to facilitate study partner participation in clinical trials, such as by removing logistical barriers, offering payment, and providing paid, protected time off for study visits. The authors suggest that incentivizing participation, especially among non-spousal partners, could improve overall recruitment rates and generalizability of study results. Largent EA, Karlawish J, Grill JD. Study partners: Essential collaborators in discovering treatments for Alzheimer's...

Two articles and an editorial address the question of whether paying research participants could be considered coercive. The first article notes concerns about risks, consent, and exploitation. The second article examines coercion as subjection, in which someone’s interests can be partially set back in virtue of being subject to another’s foreign will. The editorial weighs the arguments and views participation as work that should be fairly compensated. Malmqvist E. “Paid to endure”: Paid...

In collaboration with Nuestra Casa, a local community health advocacy organization, the Stanford Alzheimer’s Disease Research Center (ADRC) designed and successfully implemented a dementia awareness campaign in East Palo Alto, CA. The largely Latino community near Stanford had little knowledge of dementia and its consequences. This article describes the community-based participatory research model that was used to create materials and training for 20 promotoras (community outreach workers). The...

This report shows the feasibility of recruiting individuals age 90 and older into longitudinal clinical research and provides preliminary guidance related to the effectiveness of recruitment strategies.

The purpose of this mixed-methods interview study was to elucidate how people with mild cognitive impairment and their study partners decide whether to enroll in clinical trials.

Researchers conducted focus group interviews with five groups of stakeholders to ask about their views on receiving results of an amyloid positron emission tomography (PET) scan.

Researchers tested a two-step process for recruiting asymptomatic, amyloid-positive individuals into clinical trials.

To address the challenges of recruiting patients into early-phase trials of mild cognitive impairment and Alzheimer’s disease, a memory clinic was implemented within the clinical trials unit of a biopharmaceutical company.

This paper describes the design and development of a tablet-based decision support tool to enhance shared decision making and decisional capacity for people with a genetic condition that causes development problems and cognitive impairment who are participating in the informed consent process.

Through retrospective analysis, the researchers tested the potential utility of using a GIS tool as part of a targeted recruitment strategy for reaching populations that are challenging to include in dementia care clinical trials.

Trial managers and other staff from five active United Kingdom-based randomized clinical trials were interviewed to explore retention strategies and factors that influence which retention strategies the team chose to adopt. (Dementia was the clinical topic of one of the five trials.) The study authors reported that the role of trial staff and their underlying behaviors influence the practices of the team members responsible for retention, and that institutional emphasis on recruitment can...

Semi-structured qualitative telephone interviews were conducted with 17 staff members from a United Kingdom-based Alzheimer’s trial (Reducing pathology in Alzheimer’s Disease through Angiotensin TaRgeting, RADAR) to explore barriers and facilitators to recruitment. The researchers found that challenges to Alzheimer’s trial recruitment can occur at the care pathway and at clinician, patient, and companion levels. They suggest that recruitment can be facilitated by improving diagnostic processes...

More than 25 plain-language informational brochures in English have been developed to enable and improve communication between clinical research staff and research participants. Most of the brochures are available in an additional 15 languages.

This systematic review included 19 studies that involved recruitment and retention of African Americans (15 studies), both African Americans and Latinos (2), and Asians (2). Four major themes were identified for recruitment strategies: community outreach (94.7%), advertisement (57.9%), collaboration with healthcare providers (42.1%), and referral (21.1%). Three major themes were identified for retention strategies: follow-up communication (15.8%), maintain community relationship (15.8%), and...

GeneMatch is a first trial-independent research enrollment program designed to recruit and refer cognitively healthy adults to Alzheimer’s prevention studies based in part on APOE test results. It enrolls individuals aged 55 to 75 years who live in the United States and self-report not having a diagnosis of cognitive impairment. Participants enroll online and are provided a cheek swab kit for APOE genotyping. Participants are not told their APOE results, though the results may be used in part to...

This searchable repository of articles related to engagement in research is organized around four types: papers describing engagement experiences; papers on research findings that also report on engagement; studies of engagement practices; and other important works that guide the field, including frameworks, conceptual models, and editorials. The repository is maintained by the Patient-Centered Outcomes Research Institute, which works with healthcare stakeholders to identify critical research...

An online survey of 556 recruitment practices across the NRG Oncology network (a nonprofit research organization formed to conduct oncologic clinical research) was conducted to learn about recruitment of participants from minority/underserved populations. The survey response rate was 34.9 percent. The most effective methods reported for recruiting minority/underserved participants were patient navigators (44.4 percent) and translators (38.9 percent). All institutions reported using a mechanism...

This case study examines how the use of community engagement principles and approaches enhanced clinical trial recruitment and retention. The Meharry Vanderbilt Community Engaged Research Core (CERC), which facilitates community involvement in clinical and translational research, was consulted to enhance participation of African-American women in a clinical trial. CERC's key recommendations included: 1) convene a Community Engagement Studio, 2) redesign the recruitment advertisement, 3) simplify...

This review examined 20 studies to identify successful community-engaged interventions that included healthcare providers as a key strategy in addressing barriers to clinical trial enrollment of underrepresented patients. Of the studies, 9 addressed cancer clinical trials and 11 addressed trials related to chronic medical conditions, including diabetes, hypertension management, and chronic kidney disease. The key strategies employed were categorized according to their presumed impact on barriers...

This article explores strategies to improve participation in cognitive aging research by older adults, particularly minority older adults. The cultural aspects of cognitive aging are examined, especially the role of stigma and stereotype threat. The perceptions of cognitive aging of African American and Hispanic older adults are also described. Specific strategies are presented that have been successfully implemented to improve recruitment and retention in research targeting minority older...

The current state of the literature on recruitment and retention strategies in clinical studies of low-income and minority populations was assessed in a review of 165 studies published in English between 2004 and 2014. Data extracted included information on the study type (descriptive or analytical), study design, study focus (recruitment, retention, or both recruitment and retention), health outcome, specific minority group, special population or age group, whether specific recruitment...

A sample of 304 African-American participants from the Washington, D.C., metropolitan area completed a survey evaluating beliefs about medical research and preferred research study methods. Results showed 90 percent believed that medical research was necessary and assists in finding a cure for a disease. Most respondents expressed a preference for participating in research related to issues with which they were familiar (e.g., diabetes or hypertension) or for working with researchers of a...

In-depth, semi-structured, telephone interviews were conducted with 31 research investigators experienced with minority populations, to explore their perspectives regarding how their own racial and ethnic background influenced their ability to recruit minorities. The analysis addressed the benefits and potential risks of racial concordance ("race-matching") in research recruitment (i.e., it is not a "magic pill"), and the importance investigators themselves placed on "being really connected" and...

Researchers surveyed 1,643 participants to investigate potential motivators, barriers, and facilitators to participation in research that tests a new drug or device. Participants were Caucasian, African American, Hispanic, multiracial, and "other" minorities. Motivators were measured on a scale that ranged from "no influence" (0) to "most influence" (4). Significant differences by race were found for five out of 10 motivating factors. "Risk of unknown side-effects" was the greatest barrier for...

This article synthesized findings from health research studies that evaluated the cost and effectiveness of different recruitment strategies to inform investigators on designing cost-efficient clinical trials. Researchers identified 10 randomized studies that compared recruitment strategies, including monetary incentives (cash or prize), direct contact (letters or telephone call), and medical referral strategies. Only two of the 10 studies compared strategies for recruiting participants to...

This study modeled Alzheimer’s disease prevention clinical trials in order to assist investigators in making trial design choices. The authors used data from the National Alzheimer's Coordinating Center Uniform Data Set to model trial sample sizes, the numbers needed to enroll to account for dropout, and the numbers needed to screen to successfully complete enrollment. Researchers then examined how enrichment strategies affected each component of the model. For example, enriching for subjective...

The authors propose EER a systematic approach to research participant recruitment so as to address the inadequate recruitment of underserved populations The guideline is referred to by the acronym EERC, for evaluate, engage, reflect, and carefully match. These terms stand for: 1) Evaluate the composition of the research team, 2) Engage fully with the community by working with key informants and cultural insiders, 3) Reflect the unique cultural characteristics of the community in the research...

How professional recruiters approach patients is a critical determinant of enrollment into research studies and clinical trials. Findings indicate that recruiters use several verbal strategies in the communication process, including translating study information (such as simplifying, using examples, and substituting specific difficult or problematic words), using linguistic reframing or metaphors, balancing discussions of research participation risks with benefits, and encouraging potential...

In this prospective cohort study, 204 adults were invited to join an online survey to assess the likelihood of their participation in clinical research, depending on how the term "clinical research" was defined. Both short and extended definitions were used; the five short definitions were: clinical trial, clinical study, health-related research study, community participatory study, and quality improvement study. The likelihood of participation in clinical research was the lowest when "clinical...

This reviewed examined 15 articles to identify challenges and strategies pertaining to recruitment and retention of frail older adults in research studies. Lack of perceived benefit, distrust of research staff, poor health, and mobility problems were identified as common challenges. Common strategies used were to establish a partnership with staff that participants knew and trusted and to be flexible about the time and place of the study. Few studies performed analyses to compare the impact of...

A telephone survey of 511 people in one Southern state explored the communication sources and perceived effective communication channels and strategies through which African Americans and White individuals receive clinical trial information.

Recommendations and guidelines to increase the participation of minorities in health-related research typically pertain to research in clinical or laboratory contexts. This article summarizes community-engaged outreach efforts that can be translated into usable strategies for health education research teams seeking to diversify the pool of research participants. The article provides an overview of the various components of a research endeavor that may influence minority participation in health...

This article describes the challenges encountered in recruiting, into five research studies, Mexican American participants from community settings. Culturally relevant strategies used to recruit are also described. The most effective recruitment strategies reflected the common cultural values of personalismo, simpátia, confianza, respeto, and familismo. García AA, Zuñiga JA, Lagon C. A personal touch: The most important strategy for recruiting Latino research participants. Journal of...

A telephone survey was conducted with rural and urban residents in South Carolina to examine potential barriers to participation in clinical trials. The survey explored structural and procedural barriers (e.g., limited accessibility) and cognitive and psychological barriers (e.g., fear, distrust). Findings indicated that there were no significant differences between rural and urban residents in their willingness to participate in a clinical trial. However, rural residents were more likely to...

This paper discusses a variety of methods that were successful in exceeding target recruitment and retention goals in a randomized clinical trial of hearing protector use among farm operators. Recruitment and retention strategies were: based on a philosophy of mutually beneficial engagement in the research process, culturally appropriate, tailored to the unique needs of partnering agencies, and developed and refined in a cyclical and iterative process. These approaches may result in enhanced...

Rural residents diagnosed with cardiovascular disease (CVD) or with CVD-related risks are underrepresented in behavioral intervention trials. This literature review condensed the evidence and developed a conceptual framework of interlinked, multi-level factors affecting participation. In addition to contextual factors (i.e. patient, community and research levels), common factors impacting rural patients’ intent to enroll included lack of awareness and understanding about behavioral trials...

In this study, researchers evaluated the perceived success of recruitment and retention protocols for Native Hawaiian/Pacific Islander/Filipino adult populations. Focus groups and questionnaires were used to identify themes related to facilitators and deterrents to participation in clinical trials in these populations. Responses to animated videos and vignettes with actors regarding clinical research participation were analyzed. Researchers found that successful recruitment and retention...