GeneMatch Registry Recruits Subjects for Prevention Trials
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As Alzheimer’s prevention trials get underway, researchers are developing tools that can identify people at greatest risk for the disease and expedite their recruitment. Enter the newest resource—GeneMatch, announced this week by principal investigator Jessica Langbaum and colleagues at Banner Alzheimer’s Institute in Phoenix. The new program piggybacks on the Alzheimer’s Prevention Registry (APR), which has recruited more than 185,000 people who are interested in participating in AD research. Through GeneMatch, APR registrants will have the option of donating DNA for ApoE4 genotyping. Researchers will then be able to instantly identify participants who fit particular ApoE selection criteria, speeding enrollment into clinical trials.
“GeneMatch will dramatically shift how researchers conduct prevention studies,” said Pierre Tariot, director of the Banner Alzheimer’s Institute, at a press briefing announcing the program. Through GeneMatch, investigators will significantly cut the numbers of people they need to screen, saving significant time and money, he said.
“We need to engage the public in a major way and encourage them to participate in research to help move the field forward,” noted Stephen Salloway, Brown University, Providence, Rhode Island, adding, “GeneMatch could be a game-changer for AD research.” Salloway is an investigator in Banner’s upcoming Alzheimer’s Prevention Initiative APOE4 trial, which will test the ability of the Aβ vaccine CAD106 and the BACE inhibitor to prevent Alzheimer’s in people with two copies of the ApoE4 gene (Jul 2014 news).
GeneMatch grew out of the preparations for the API APOE4 trial. Led by Langbaum, Tariot, and Eric Reiman, also from Banner, that trial plans to screen about 80,000 people in order to find 1,300 eligible subjects who carry the requisite two copies of ApoE4, a genotype found in only 2 to 3 percent of the population. That leaves some 78,000 people, including non-carriers and ApoE4 heterozygotes, who still want to participate in research, but cannot join the trial for which they agreed to undergo genotyping in the first place. “We wanted to think about a mechanism to leverage this resource as a platform for other studies,” Langbaum told Alzforum. “GeneMatch creates a shared resource for the community.”
APR participants who are cognitively normal, live in the United States, and are between the ages of 55 and 75 can submit a cheek swab for ApoE genotyping. GeneMatch will not reveal that genotype to participants. However, volunteers may be referred to studies that reveal the information to them. They can then decide whether to learn their ApoE status. Genotyping will be carried out by Clinical Laboratory Improvement Amendments-certified labs, regulated by the Centers for Medicare & Medicaid Services. This will ensure the testing is held to accepted standards and the results are certified for the consumer. Some direct-to-consumer genetic tests are not CLIA-certified. GeneMatch is funded jointly by the National Institute on Aging, the Alzheimer’s Association, GHR Foundation, Banner Alzheimer’s Foundation, and FBRI. (FBRI is a subsidiary of FMR LLC, which also funds Alzforum.)
In developing GeneMatch, API scientists sought advice from experts in the ethical and legal implications of genetic disclosure, including Jason Karlawish, University of Pennsylvania, Philadelphia, and J. Scott Roberts, University of Michigan, Ann Arbor. They helped design the program so that communication with participants does not inadvertently reveal their ApoE4 genotype. For example, if a company or academic sponsor wants to test the effect of a given treatment in ApoE4 homozygous carriers, that sponsor invites people of all genotypes so that the simple receipt of an invitation does not give away genetic status. If a trial requires that patients learn their genetic status (most trials to date do not), investigators now have specific disclosure protocols designed to protect patients who may cope poorly with the revelation (see Aug 2015 conference news; and conference news).
Langbaum did not specify which trials might use the database, but said that a number of scientists from outside API had expressed interest. Investigators will go through a rigorous application process because GeneMatch holds sensitive genetic information, said Langbaum. She and colleagues are still working out policies and procedures for access to the data.
Investigators in the United Kingdom, Germany, Spain, and France have expressed interest in expanding GeneMatch to their countries. Langbaum and colleagues are currently working out the requisite ethical and legal considerations.
GeneMatch joins several other initiatives that benefit from the interest of the general public to take part in research and clinical trials. Among these are the Brain Health Registry led by researchers at University California San Francisco, the Alzheimer’s Association’s Trial Match, the United Kingdom’s Join Dementia Research, and the Global Alzheimer’s Platform Trial-Ready Cohort. “There’s real momentum to build a global infrastructure to accelerate AD drug development,” said Salloway.—Gwyneth Dickey Zakaib
References
Therapeutics Citations
News Citations
- Novartis to Partner with Banner Health on ApoE4 Prevention Trial
- How Do You Communicate Alzheimer’s Risk in the Age of Prevention?
- Testing a New Model for Disclosure of ApoE4 Status
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Comments
I want to say "thanks" to scientists for developing tools that can identify people at greatest risk for the disease, and expedite their recruitment. This is great work.
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