by
John R. Fischer, Senior Reporter | April 05, 2023
The National Institute on Aging is creating a database that will identify health patients at risk for Alzheimer's disease.
To facilitate earlier diagnoses of Alzheimer’s disease, which can start 20 years before memory issues develop, the U.S. National Institute on Aging is investing $50 million annually for the next six years into a research database that will track the health of Americans for decades.
In light of the recent accelerated FDA approval for Leqembi, a treatment developed by Eisai and Biogen that slows Alzheimer's progression in early-stage patients and is expected to obtain standard approval in July, the U.S. government is looking to expand clinical trial participation and better assess the efficacy of different treatments for the disease.
Drawing from medical records, insurance claims, pharmacies, mobile devices, sensors and government agencies, the platform will be capable of holding long-term health data of 70% to 90% of Americans to identify healthy patients at risk for AD, which affects about six million, for drug trials. It will also address chronic racial and ethnic gaps within clinical trials, and could potentially boost enrollment outside urban academic medical centers,
according to Reuters.
Additionally, the solution, which will run on a secure computing environment, may be used to monitor patients following treatments.
"Real-world data is what we need to make a lot of decisions about the effectiveness of medications and looking really at a much broader population than most clinical trials can cover," Dr. Nina Silverberg, director of the NIA's Alzheimer's Disease Research Centers program, told Reuters.
Silverberg says that while not designed for this purpose, “it might be possible” to use the platform to help facilitate reimbursement for providers that use them, and that it could be used to identify patients most at risk for other diseases, such as COVID-19.
The grant was posted on March 13, with funding to start as early as April 2024. The NIA expects a fully developed registry after 21 months.
"We envision this platform will allow researchers to recruit across the United States. If we are to play a greater role in prevention, we must start early. That is not at age 65," said Partha Bhattacharyya, chief data officer of the NIH Office of Data Resources and Analytics.
