US to create Alzheimer's research database in ~$300M project - report
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The U.S. National Institute on Aging (NIA) is funding an up to $300M project to create a research database for Alzheimer's disease (AD) which can track Americans' health for many years and help researchers to get insights on AD, Reuters reported.
The NIA plans to create a data platform â under the six-year project â capable of hosting long-term health information of 70% to 90% of the U.S. population, the report added.
The platform will pick information from medical records, insurance claims, pharmacies, mobiles, sensors and other government departments.
The funding announcement puts the earliest beginning date to be April 2024, with an aim to set up an AD registry 21 months later.
"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," said Director of NIA's Alzheimer's Disease Research Centers program Nina Silverberg to the news agency.
At the start of the year, the FDA granted accelerated approval to Biogen (NASDAQ:BIIB) and Eisai's (OTCPK:ESALF) (OTCPK:ESAIY) Leqembi (lecanemab) to treat patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of AÎ² pathology. The FDA's decision on whether the drug gets full approval or not is likely to take place by July 6.
When the data platform is created, it could also track people after they get therapies such as Leqembi.
The U.S. Medicare health plan for older adults may require such tracking in a registry as a stipulation of reimbursement for Leqembi, the report added.
Silverberg noted that they did not design the platform for this purpose but it could be possible to use it for that reason
The platform may also support researchers working in other disease spaces to understand which patients are more at risk and the impact of drugs, according to the report.