The U.S. National Institute on Aging (NIA) is funding a 6-year, $300 million initiative to create a sizable Alzheimer’s research database that will allow scientists to learn new things about the debilitating disease.
Officials from the National Institutes of Health (NIH), which includes the NIA, told Reuters that the funding will be used to create a data platform that will be able to store long-term health information on 70% to 90% of the American population.
The database might help identify healthy individuals who are at risk for Alzheimer’s
According to them, the platform will use information from medical files, insurance claims, prescriptions, pharmacies, mobile devices, sensors, and different governmental organizations.
“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, said in an interview.
The illness, which can begin up to 20 years before memory problems appear, can be tracked in patients both before and after they begin to show symptoms.
Leqembi, a novel medication that slows the progression of the disease in patients in the early stages, has sparked a surge in interest in Alzheimer’s research.
The platform could also keep track of patients after they undergo treatments
For upcoming drug trials, the database might help identify healthy individuals who are at risk for Alzheimer’s, which affects about 6 million Americans. Additionally, it seeks to address the persistent underrepresentation of people of color and other ethnic groups in Alzheimer’s clinical trials and may aid in boosting enrollment from locations other than urban academic medical institutions.
Once developed, the platform could also keep track of patients after they undergo treatments like Leqembi, which was granted accelerated approval in the United States in January and is anticipated to be given traditional FDA approval by July 6.
The U.S. Medicare health plan for older adults will likely require such tracking in a registry as a condition of reimbursement for Leqembi.
“We didn’t design it for that purpose,” Silverberg said, but “it might be possible” to use it for that purpose.
The United States lagged behind other nations with national health systems during the pandemic in its ability to evaluate patient data for COVID-19.
The platform will draw on data from medical records, insurance claims, pharmacies, mobile devices, sensors, and various government agencies
According to Silverberg, the system would be created in a secure computing setting with several limitations to guarantee the privacy of people’s health information.
The grant took years to complete and was finally submitted on March 13. The funding statement targets an Alzheimer’s registry to be established 21 months after the funding announcement’s earliest start date of April 2024.
In order to debate the platform’s design, several stakeholders, including Medicare and the Alzheimer’s Association, and UsAgainstAlzheimer’s, participated in a workshop last spring.
The Alzheimer’s Association intends to submit an application for the NIA platform grant, which will provide $50 million annually for up to six years, according to Chief Science Officer Maria Carrillo.