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GeneMatch Registers 76,000 Alzheimer’s Research Volunteers



By Maxine Bookbinder

March 25, 2019 | An innovative at-home program that recruits and refers healthy individuals for Alzheimer’s Disease (AD) clinical trials nationwide is sharing its design, program results, and participant feedback for the first time with the scientific community.

GeneMatch, launched in 2015 by the Banner Alzheimer’s Institute, aims to create a pool of volunteers with APOE gene status and no cognitive disorders who are willing to participate in research and preventive clinical trials for AD.  The article appeared last month in Alzheimer’s & Dementia (DOI: 10.1016/j.jalz.2018.12.007).

The purpose of GeneMatch is to accelerate prescreening, recruitment, and enrollment of AD pre-clinical and prevention clinical trials. However, it can also recruit for a range of non-APOE studies, such as research on elevated brain amyloid. It is funded in part by grants from the National Institute on Aging, FBRI, GHR Foundation, and the Alzheimer’s Association and is open to U.S. residents between the ages of 55–75 who self-identify as cognitively non-impaired. GeneMatch does not run clinical trials.

“The longer it takes to enroll, the longer it takes to complete research and find more answers,” says Jessica Langbaum, principal scientist at Banner Alzheimer’s Institute and Associate Director of the Alzheimer’s Prevention Initiative. “We want GeneMatch to be a resource for researchers, to think of GeneMatch as a recruitment tool for studies. We want to make clinical trials efficient and reduce screen-fail rates.”

Approximately 5.7 million Americans currently have AD; by 2050, the estimated number is 14 million.  The challenges involved with recruiting for AD trials exceed those of other trials, due to age and health requirements, the stigma associated with AD in general and within specific ethnic and cultural populations.

According to ClinicalTrials.gov, there are currently 220 studies in the US recruiting for AD clinical trials, including 32 studies recruiting for AD prevention trials and 20 other studies recruiting for pre-clinical trials.

Subsequently, GeneMatch fills a void to more quickly and efficiently reach out, identify, refer, and ultimately match up potential volunteers with appropriate clinical trials, including studies involving specific biomarker evidence, genetic risks, or other particular factors.

The program, which continues to evolve, has registered almost 76,000 participants; about 30% have one APOE4 allele, and another 3% have two APOE4 alleles.

Like any new program, GeneMatch required some fine-tuning. Anecdotal feedback helped to improve the program design, says Langbaum.  For example, as a result of consumer comments, the website enrollment flow was reorganized. Initially, it addressed all questions throughout the site and ended with a 5-minute video and review informational quiz. “We found that people want information at different paths along the way and we reordered how information is given,” says Langbaum. They put educational information up front and added a dedicated FAQs page to answer common reader concerns, such as privacy, security, and genetic discrimination, in one place. “We thought we had addressed all questions in the website content. People clearly wanted a one-stop shop to find information.” At the end, viewers can choose between the video or a companion text. “We are trying to address people’s different learning styles,” says Langbaum. The quiz, designed to help readers integrate and absorb the information, still remains.

Security is a natural concern for an Internet recruitment site that collects DNA and stores APOE genotypes. Only the de-identified APOE genotype test is stored; all DNA is destroyed after genotyping. “This was a strategic decision,” says Langbaum. “This could be a limitation of the program. If, down the road, another genetic marker becomes of interest, it will be better off to contact individuals and ask for a new sample rather than store it for unidentified future use.” Researchers don’t have access to the database; GeneMatch contacts eligible participants on the researchers’ behalf and personal information is only transferred to study sites after volunteers agree to it.

To keep the registration process simplified, GeneMatch relies on participants’ self-identification on cognition and does not confirm self-assessments. “We could have had online assessments with a battery of tests but felt this was not appropriate,” says Langbaum. “We wanted to keep the website user-friendly.” In addition, adds Langbaum, cognitive status can change between the time the participant registers with GeneMatch and later is recruited for a clinical trial. “It’s up to the study site to do a proper screening to ensure the person meets eligibility requirements.”

GeneMatch did not escape the universal recruitment problem of under-representation of men and minorities, which plagues principle investigators globally. Last year, it launched a successful Facebook media campaign targeting men, with ads saying they are underrepresented in AD testing and that GeneMatch needs their help. As a result, male registration grew from 21% - 44%. “We are continuing to test different messages,” says Langbaum. “Social media ads are very helpful.” Future efforts may look at different platforms and banner ads on Google.

Later this year, they hope to collaborate with another research group to address the under-representation of minority enrollment. About 1/3 of potential GeneMatch registrants choose not to answer background race and ethnicity questions, possibly due to fear of profiling with their collected DNA. About 64% self-identify as Caucasian, another 1% self-identify as either black or Latino, and less than 1% identify as Asian. “The NIH set a goal of 20%” minority representation, says Langbaum. “It’s a high bar but we hope to achieve it.”

And for good reason.  According to Alzheimer's Association 2017 Alzheimer's Disease Facts and Figures , in adults 65 and older, blacks are about twice as likely to suffer from AD or other dementias; Hispanics are about 1.5 times as likely.  Langbaum says the rate of APOE4 in certain Asian populations is lower than European whites.

One way GeneMatch tried to reach out to diverse demographics was through collaborations with 30 community partner sites; more will be added.  Volunteers at these sites introduce GeneMatch to potential participants and perform cheek swabs. While this increases the number of swabs sent in, it doesn’t necessarily translate into an increase in study participation. It is still unknown if more volunteers from partner sites accept study invitations and enter trials than volunteers who complete the cheek swab and registration on their own. In addition, some community outreach sites only register “a handful” of volunteers, depending upon individual community’s outreach capabilities and priorities.

Langbaum says they have run into unexpected difficulties. For example, some people have refused to volunteer because GeneMatch will not disclose APOE genotypes. “We are following medical guidelines to not reveal APOE test results and genotype.  Disclosure of genetic information is the practice of medicine and guidelines for doing so differs within different states. APOE is not actionable; we are not withholding actionable information. If the guidelines change down the road that would allow us to appropriately share this information with participants, we would certainly be open to it but right now not something we are equipped to do.”  Langbaum says that GeneMatch tells interested people about direct to consumer testing companies, but that using a licensed health care provider is best.

On the other side, some clinical studies require participants to know their APOE genotype. However, any participant who does not want to know can decline to participate in that study.

GeneMatch continues to modify and perfect itself.  Goals include increasing gender, ethnic, and racial diversity enrollment, gaining an understanding of the barriers and stigmas preventing certain demographic groups from enrolling, increasing active partner sites, and examining the program’s effectiveness: if it actually does expedite enrollment in trials, and if it lowers screen-fail rates.

Langbaum says, “We want to continue growing the program and study different ways we can increase study effectiveness of whether GeneMatch can accelerate enrollment into trials and make effective contributions.”

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