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ACTIVE MIND: An adaptive clinical trial of cognitive training to improve function and delay dementia

Award Number: R01AG075014
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2024
PERIOD OF PERFORMANCE END DATE: 03/31/2028

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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 condition20 in the US and affects more than 5 million Americans21. Analyses from the ACTIVE study showed that a specific type of computerized cognitive training (CTa) reduced risk of ADRD among older adults 29% across 10 years22. [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 years23]. While these results are encouraging, 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 mild cognitive impairment (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 random- ized 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 improve- ments 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 indi- ces of instrumental activities of daily living (IADL), standard cognitive assessments, as well as neu- roimaging 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 neu- roimaging 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 im- plemented 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 205024.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $4,153,967 )
2026	2026	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Aging Research	001	4	4/8/2026	NON-COMPETING CONTINUATION	$4,153,967
2026	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Aging Research	000	3	1/30/2026	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $4,153,967

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Aging Research	000	3	11/5/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2025	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Aging Research	002	3	8/20/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2025	2023	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Aging Research	001	2	4/23/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $4,555,241 )
2024	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Aging Research	002	3	8/30/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$4,555,241
2024	2023	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Aging Research	001	2	8/30/2024	NON-COMPETING CONTINUATION	$0
2024	2023	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Aging Research	000	2	4/3/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $4,555,241

Issue Date FY: 2023 ( Subtotal = $4,604,476 )
2023	2023	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Aging Research	000	2	8/14/2023	NON-COMPETING CONTINUATION	$4,604,476
														Subtotal = $4,604,476

Issue Date FY: 2022 ( Subtotal = $5,508,175 )
2022	2022	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Aging Research	000	1	8/22/2022	NEW	$5,508,175
														Subtotal = $5,508,175

Grand Total All Awards = $18,821,859

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ACTIVE MIND: An adaptive clinical trial of cognitive training to improve function and delay dementia

Award Number: R01AG075014

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2024

PERIOD OF PERFORMANCE END DATE: 03/31/2028

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