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A Novel Computerized Cognitive Stress Test Designed for Clinical Trials in Early Alzheimer's: Relationship with Multimodal Imaging Biomarkers in Diverse Cultural Groups

Award Number: R01AG061106
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2019
PERIOD OF PERFORMANCE END DATE: 11/30/2024

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A Novel Computerized Cognitive Stress Test Designed for Clinical Trials in Early Alzheimer's: Relationship with Multimodal Imaging Biomarkers in Diverse Cultural Groups - Project Summary Emerging clinical trials focusing on preclinical Alzheimer's disease (AD) are expected to be most effective in the earliest or even prodromal stages of illness, before significant multi-system degeneration has occurred. To that end, it is critical to the success of emerging clinical trials to be able to identify and target individuals that are truly at-risk for AD. Reliably identifying these at-risk individuals; however, is currently cost prohibitive in large-scale trials given the reliance on AD biomarkers such as amyloid imaging to increase confidence in the diagnostic determination. To facilitate the feasibility of preclinical AD trials, the field must develop clinical outcome measures that are validated to identify early disease states with high levels of sensitivity and specificity. This approach in turn, would be significantly cost effective and has the potential to ultimately optimize clinical trial enrollment. Outcome measures must also be effective in measuring potential changes in treatment response over time, be related to biomarkers of early AD pathology (e.g., amyloid load, tau deposition, volumetric loss in AD prone regions on MRI), and be cross-culturally applicable given the growing Hispanic population in the United States. Our laboratory has been at the forefront of developing assessment paradigms that are both sensitive and specific to preclinical AD. One such novel memory paradigm, the LASSI-L taps the failure to recover from proactive semantic interference (frPSI) and has been shown to be significantly more sensitive to early cognitive deficits than learning inefficiency or simple rate of forgetting as is measured by the ADAS-Cog. The LASSI-L has also outperformed other widely used measures in detecting preclinical AD. More specifically, frPSI has been observed in otherwise cognitively normal elders with high amyloid load and decreased volumes in AD prone regions among elders with amnestic MCI (aMCI) and PreMCI suggesting that this paradigm represents a cognitive marker of very early AD. We have now significantly expanded our earlier work to develop a computerized Cognitive Stress Test (CST), designed to more strongly elicit cognitive markers of preclinical AD. In the current study, we intend to validate this novel and more powerful CST for use in preclinical AD trials by examining the performance of 240 Hispanic and non-Hispanic individuals with early stage MCI (eMCI) as compared to elders with no cognitive impairment and in relation to traditional measures employed in AD clinical trials such as the ADAS-Cog, longitudinally. We will also examine the relatedness of the CST to biological markers of AD: PET amyloid load, MRI measures of volume and cortical thickness, DTI and tau burden. The proposed investigation will provide an unparalleled opportunity to validate and establish a novel and promising cognitive outcome measure specifically designed to detect preclinical AD, for use in preclinical AD trials as both potential screening and outcome measures. We strongly believe that this can result in critical contributions to the field.


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: 2025 ( Subtotal = -$26,926 )
2025	2023	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Aging Research	000	5	4/9/2025	NON-COMPETING CONTINUATION	-$26,926
														Subtotal = -$26,926

Issue Date FY: 2023 ( Subtotal = $689,303 )
2023	2023	UNIVERSITY OF MIAMI	1400 NW 10TH AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Aging Research	000	5	1/9/2023	NON-COMPETING CONTINUATION	$689,303
														Subtotal = $689,303

Issue Date FY: 2022 ( Subtotal = $717,742 )
2022	2022	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Aging Research	000	4	12/8/2021	NON-COMPETING CONTINUATION	$645,966
2022	2022	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Aging Research	001	4	4/21/2022	NON-COMPETING CONTINUATION	$71,776
														Subtotal = $717,742

Issue Date FY: 2021 ( Subtotal = $726,721 )
2021	2021	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Aging Research	000	3	12/28/2020	NON-COMPETING CONTINUATION	$654,048
2021	2021	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Aging Research	001	3	2/11/2021	NON-COMPETING CONTINUATION	$72,673
														Subtotal = $726,721

Issue Date FY: 2020 ( Subtotal = $730,920 )
2020	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Aging Research	000	2	12/2/2019	NON-COMPETING CONTINUATION	$657,827
2020	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Aging Research	001	2	1/23/2020	NON-COMPETING CONTINUATION	$73,093
														Subtotal = $730,920

Issue Date FY: 2019 ( Subtotal = $748,976 )
2019	2019	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Aging Research	000	1	1/30/2019	NEW	$748,976
2019	2019	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Aging Research	001	1	3/14/2019	NEW	$0
														Subtotal = $748,976

Grand Total All Awards = $3,586,736

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A Novel Computerized Cognitive Stress Test Designed for Clinical Trials in Early Alzheimer's: Relationship with Multimodal Imaging Biomarkers in Diverse Cultural Groups

Award Number: R01AG061106

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/01/2019

PERIOD OF PERFORMANCE END DATE: 11/30/2024

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