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NIH now funds more than 400 active clinical trials on Alzheimer’s disease and related dementias prevention, treatment, and caregiving . Of these, about 200 are testing interventions for effective prevention and treatment of these diseases, and others are testing dementia care and caregiving interventions.
To ensure that findings will be relevant for all people, clinical trials must include participants who reflect the diversity of the U.S. population.
NIH continues to invest in initiatives to support the recruitment of participants from various races, ethnicities, genders, ages, and socioeconomic statuses. These investments — including grants for new recruitment approaches, resources for creating culturally sensitive recruitment materials, and innovative tools to monitor outreach and recruitment — are helping scientists and clinicians better reach groups that have been historically underrepresented in biomedical research.
NIH is also working to move beyond the confines of large academic medical centers to work more closely and directly with communities on research into Alzheimer’s and related dementias.
NIA study underscores that clinical trial data must be representative of all communities
In 2021, NIA-funded research found significant differences in the extent to which sociodemographic, health, and genetic risk factors were linked to cognitive and neuroimaging results for dementia based on the study population.
Researchers compared data from two other NIH-funded studies:
- The clinic-based Alzheimer’s Disease Neuroimaging Initiative (ADNI) , whose participants are predominantly White
- The community-based Atherosclerosis Risk in Communities (ARIC) study , which includes Black and White participants
The findings reinforce the fact that the results identified in a single population cannot be assumed to represent the population as a whole and that studies that include participants from diverse backgrounds are critical to establishing a holistic understanding of population and individual-level health outcomes.
NIA’s new online tool can help boost participation in dementia clinical studies
In 2021, NIA launched Outreach Pro , a tool that helps researchers, clinicians, and local communities increase awareness of and participation in clinical trials involving Alzheimer’s and related dementias. Outreach Pro provides resources for creating customized recruitment materials in multiple languages for potential study participants who are African American/Black, Hispanic/Latino, and Asian American and Pacific Islander.
Outreach Pro is an integral part of NIA’s efforts to implement the National Strategy for Recruitment and Participation in Alzheimer’s and Related Dementias Clinical Research .
Outreach Pro’s recruitment resources include web content, brochures, fact sheets, social media posts, photos, videos, and motion graphics. These materials incorporate culturally sensitive, nationally tested messages, taglines, concepts, and images that resonate within specific communities.
An NIA repository provides a wealth of additional resources for clinical trial recruitment
NIA’s Alzheimer’s & Dementia Outreach, Recruitment, and Engagement Resources (ADORE) is a repository of resources for engagement, recruitment, and retention of clinical trial participants. Researchers can search for materials by keyword, explore by tag, or review a wide range of topics to find materials that will work best for their study.
The repository houses materials to help researchers plan their recruitment strategies and engage specific populations. ADORE also enables researchers to share their recruitment resources, helping amplify the impact of successful recruitment and retention tools. In 2021, the tool was accessed nearly 30,000 times.
In 2021, NIA began working with all researchers conducting NIA-funded clinical trials to enter enrollment data into CROMS each month.
Monitoring clinical trial enrollment will help address challenges
NIA’s Clinical Research Operations & Management System (CROMS) offers real-time tracking, reporting, and management of clinical trial enrollment data, study documents, and study activities.
In July 2021, NIA began working with all researchers conducting NIA-funded clinical trials to enter enrollment data into CROMS each month. The ability to closely monitor participant enrollment data enables NIA staff to help researchers address enrollment challenges promptly and work toward improving the enrollment of underrepresented communities in dementia clinical trials.
To date, every NIA-funded trial as of July 2022 has an entry record in CROMS.
NIH leads new recruitment strategies to encourage clinical trial participation
In 2022, NIA released a Request for Information (RFI) to learn more about using community-based research networks to increase diversity of participants in clinical trials for Alzheimer’s and related dementias.
The goal is to extend beyond traditional academic and medical research centers and work with community-based clinicians, primary care centers, assisted living facilities, and other organizations to reach underrepresented groups.
RFI responses supported the need to engage communities in a consistent, sustainable, and authentic way, including through community-based research networks. With NIH funding, the networks could help ensure that interventions improve the lives of all people living with dementia.