An official website of the United States government
Evaluate and update current trial funding models to ensure the ability to test novel first-in-class therapeutics in the context of the full range of expenses and time frames required for robust evaluation and sharing.
2025 4.Y Achieved DN 2021 AD Summit: 4.J PAR-23-274: Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel therapeutic Agents for the Spectrum of Alzheimer's Disease (AD) and AD-related Dementias (ADRD) (UG3/UH3 Clinical Trial Required) Translational Tools, Infrastructure, and Capabilities 2024
- Create a research program that enables academic institutions and small biopharma companies developing first-in-class AD/ADRD therapeutics to conduct first in human trials and seamlessly transition to early-stage clinical trials in the intended patient population.
Summary of Key Accomplishments
As of March 2024, NIA is funding more than 150 early- and late-stage clinical trials focused on lifestyle and behavioral interventions, such as cognitive training, brain stimulation, and exercise. For example, a recent NIA-funded study found that tai chi, particularly an innovative form that combines mental puzzles and challenges with the traditional physical movements, improved cognition in older adults with mild cognitive impairment.
Several trials of risk reduction approaches reported out in 2023: one trial found that hearing aids reduced the rate of cognitive decline in older adults at high risk of dementia by almost 50% over a three-year period; findings from another set of clinical trials suggest that a daily multivitamin modestly improves memory and cognition in older adults; and recent findings from a pilot study of personalized health coaching, aimed at addressing an individual’s specific dementia risk factors led to modest improvements in cognitive composite score, dementia risk factors, and quality of life compared with a health education control group. While more research is needed in this area, these findings add to the existing evidence that intensive control of blood pressure may slow age-related brain damage and the occurrence of mild cognitive impairment, which is often a precursor of dementia. Specifically, evidence from the NIH-funded SPRINT trial and other studies has led to updated clinical guidelines, including those issued by the American College of Cardiology and the American Heart Association, for the control of blood pressure.
In addition, four trials testing various lifestyle interventions (individually or in combination) for Alzheimer’s treatment and prevention have been enhanced with biomarker data to assess responsiveness to treatment and inform the design of individualized interventions. NIA also recently funded nine studies focused on mechanisms-focused research to promote adherence to healthful behaviors to prevent mild cognitive impairment and AD/ADRD.
The key accomplishments summary is current as of July 2024.