By Maxine Bookbinder

November 29, 2016 | An effort is underway to identify and collect healthy adults with various APOE gene statuses to potentially match them with available Alzheimer’s disease research studies.

The GeneMatch program, launched in 2015 and sponsored by the Banner Alzheimer’s Institute in Phoenix, aims to create a pool of willing Alzheimer’s trial participants already characterized with APOE gene status. Trial sponsors can recruit from the pool, hopefully “accelerat[ing] the enrollment in much-needed Alzheimer’s prevention studies,” says Jessica Langbaum, principal scientist at Banner Alzheimer’s Institute and Associate Director of the Alzheimer’s Prevention Initiative. “The longer it takes to enroll, the longer it takes to complete research and find more answers. Finding effective preventative treatment to end this disease is the ultimate goal. If we had a large enough pool, more research could take place. The importance of this pool cannot be overstated.”

The Apolipoprotein E (APOE) gene has three forms, one of which is considered a risk factor for Alzheimer’s disease. DNA testing identifies volunteers with different APOE profiles, including those who may have an increased risk of developing the disease. GeneMatch allows researchers to enroll participants with certain APOE profiles to look for early brain changes in participants or compare the effectiveness of treatments. “GeneMatch,” says Langbaum, “provides a pool of individuals ready and waiting with hopefully lower screen-fail rates.”

GeneMatch does not conduct clinical trials; its purpose is to recruit enough volunteers and match them to Alzheimer’s disease studies. The program is funded in part by $33 million in grants from the National Institute on Aging, FBRI, GHR Foundation, and the Alzheimer's Association. According to Langbaum, GeneMatch is a matchmaking service, matching participants to clinical trials. To date, 9,000 people have joined GeneMatch; the goal is 30,000 by December 2016. The program is open to healthy individuals living in the U.S. between ages 55 – 75 with no diagnosed cognitive impairments. 

As any principal investigator knows, recruiting and maintaining clinical trial participants is challenging. In addition, high failure rates disqualify potential volunteers who might not apply for subsequent studies. Recruiting for Alzheimer ’s disease studies may be even more problematic, possibly due to age and health requirements and possible stigma. DNA is collected from cheek swabs and only the APOE results are extracted; all other findings are discarded. No other background, such as nutritional, exercise, or general lifestyle information, is required. Volunteers are asked to view a video, read a short explanation of the program, and then sign informed consent. “We believe that education is important in process prior to registering,” says Langbaum.

GeneMatch does not disclose APOE results to volunteers, and some people have declined to participate because of this. Results are shared only when volunteers must know as a prerequisite for participation in certain clinical trials. If they prefer not to know, they won’t be eligible for those studies.    

As for anyone else who might want to know, Banner Alzheimer’s Institute has obtained a certificate of confidentiality from the NIH; researchers can legally refuse to disclose identifying information to any local or federal subpoenas. Langbaum also believes that, currently, genetic test results should be discussed in detail with a genetic counselor and not revealed in a letter or email. 

A CLIA-certified lab does the genetic testing; other vendors support the IT infrastructure and database components, and 15 collaborating sites nationwide help with enrollment.

The current focus is on matching GeneMatch volunteers with Alzheimer’s prevention studies examining various investigational medications. However, according to Langbaum, the program could evolve over time and take on other components, such as asking potential participants for nutritional and exercise information and other health data. The effort now, however, is to protect confidentiality and minimize data collected.

So far, the Alzheimer’s Prevention Initiative Generation Study, sponsored by Novartis, a Swiss pharmaceutical company, and Amgen, a biotechnology company based in Thousand Oaks, Calif., is the first to recruit GeneMatch volunteers for a study. Other studies will be recruiting GeneMatch participants in 2017.

“GeneMatch is filling a need in scientific community,” says Langbaum. “I don’t want it [GeneMatch] to end.” For more information, contact GeneMatch at www.endALZnow.org/genematch  or genematch@endALZnow.org.