R01AG075014

Active Mind: An Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia - Project Summary

Dementia, such as Alzheimer's Disease (ADRD), is the most expensive medical condition in the US and affects more than 5 million Americans. Analyses from the Active Study showed that a specific type of computerized cognitive training (CTA) reduced the risk of ADRD among older adults by 29% across 10 years. Recent follow-up analyses indicate that Active participants with signs of mild cognitive impairment (MCI) at baseline randomized to CTA were 23% less likely to be diagnosed with ADRD across 20 years. However, MCI was not clinically diagnosed, and thus evidence is inconclusive to recommend CT for ADRD prevention.

Many efficacious CT techniques now exist but have distinct cognitive effects. Given that cognitive deficits are varied among those with MCI, who are at higher risk for ADRD, a combination of CT techniques may be most efficacious. Significant knowledge gaps remain as the best CT exercise(s) for those with MCI is unclear. We were awarded a clinical trial planning grant to design and establish the feasibility of the Active Mind Trial (AG062368).

We propose Phase II of Active Mind, an adaptive randomized trial to identify the most efficacious CT exercises to improve everyday function in MCI. We will further quantify the effect size of CT to reduce incident ADRD among persons with MCI. In this Phase II trial, our primary objective is to determine which CT arm results in the largest functional improvements and has the best probability to reduce ADRD incidence. Our investigators include international experts in CT, MCI/ADRD, recruitment and retention, neuropsychological assessment, neuroimaging, biomarkers, and adaptive trial design.

Our approach is to compare different CT arms to a stringent active control condition with equivalent participant expectations. Measures will include innovative indices of instrumental activities of daily living (IADL), standard cognitive assessments, as well as neuroimaging and novel blood-based biomarkers. Potential moderators of CT will be assessed to identify who benefits.

This study is innovative in the application of adaptive trial methodology to efficiently identify the most efficacious CT exercises to reduce ADRD incidence in MCI. We further explore neuroimaging and blood-based biomarkers as potential moderators of CT outcomes. Our premise is that targeted CT improves everyday function (i.e., IADL), which subsequently delays ADRD onset. Our long-term goal is to improve older adults' functional trajectories and thereby curb ADRD prevalence.

The contributions will be significant, advancing our understanding of how CT may be successfully implemented to curb ADRD prevalence. Significance is considerable given that an intervention delaying the onset of Alzheimer's Disease by only one year will result in 9.2 million fewer cases of the disease by 2050.

University Of Alabama At Birmingham

TO ENCOURAGE BIOMEDICAL, SOCIAL, AND BEHAVIORAL RESEARCH AND RESEARCH TRAINING DIRECTED TOWARD GREATER UNDERSTANDING OF THE AGING PROCESS AND THE DISEASES, SPECIAL PROBLEMS, AND NEEDS OF PEOPLE AS THEY AGE. THE NATIONAL INSTITUTE ON AGING HAS ESTABLISHED PROGRAMS TO PURSUE THESE GOALS. THE DIVISION OF AGING BIOLOGY EMPHASIZES UNDERSTANDING THE BASIC BIOLOGICAL PROCESSES OF AGING. THE DIVISION OF GERIATRICS AND CLINICAL GERONTOLOGY SUPPORTS RESEARCH TO IMPROVE THE ABILITIES OF HEALTH CARE PRACTITIONERS TO RESPOND TO THE DISEASES AND OTHER CLINICAL PROBLEMS OF OLDER PEOPLE. THE DIVISION OF BEHAVIORAL AND SOCIAL RESEARCH SUPPORTS RESEARCH THAT WILL LEAD TO GREATER UNDERSTANDING OF THE SOCIAL, CULTURAL, ECONOMIC AND PSYCHOLOGICAL FACTORS THAT AFFECT BOTH THE PROCESS OF GROWING OLD AND THE PLACE OF OLDER PEOPLE IN SOCIETY. THE DIVISION OF NEUROSCIENCE FOSTERS RESEARCH CONCERNED WITH THE AGE-RELATED CHANGES IN THE NERVOUS SYSTEM AS WELL AS THE RELATED SENSORY, PERCEPTUAL, AND COGNITIVE PROCESSES ASSOCIATED WITH AGING AND HAS A SPECIAL EMPHASIS ON ALZHEIMER'S DISEASE. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.866 - Aging Research

National Institute on Aging (NIA) [HHS - NIH]

Birmingham, Alabama 35294 United States

Single Zip Code

Change of Recipient Organization (Type 7 Parent Clinical Trial Optional) (PA-21-268)

Amendment Since initial award the total obligations have increased 166% from $5,508,175 to $14,667,892.