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Alzheimer's Clinical Trials Consortium (ACTC)

Award Number: U24AG057437
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/02/2017
PERIOD OF PERFORMANCE END DATE: 08/31/2028

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Alzheimer's Clinical Trials Consortium (ACTC) - This is a multi-PI application renewing the U24 Cooperative Agreement to sustain and expand the NIA’s state-of-the-art Alzheimer Clinical Trial Consortium (ACTC) responsible for conducting academic clinical trials across the continuum of Alzheimer’s disease (AD). This ACTC will continue to leverage the depth and breadth of AD clinical research teams at USC, Harvard, and the Mayo Clinic, as well as the considerable experience of investigators at 35 expert AD trial sites. We aim to sustain the optimized infrastructure that efficiently develops and conducts high quality NIH supported clinical trials in AD and related dementias.. Building on our first five years of experience, we will utilize streamlined contracting processes, a centralized IRB with a specific focus on neurodegenerative diseases, and incorporate state-of-the-art informatics and statistical analyses. We will effectively manage performance of clinical trial sites, while identifying, mentoring and supporting new trial sites to improve access to clinical trials. We will foster continued innovation in AD trial design, providing expertise on novel cognitive, imaging, and biomarker outcomes to support future ACTC trial applications. We will evaluate promising exploratory measures embedded in our current trials, such as Tau PET imaging and computerized cognitive testing, and work to incorporate these measures into a robust platform for future Proof of Concept (POC) trials to rapidly assess signals of efficacy. Our tightly coordinated, distributed leadership model has achieved a collaborative consortium that takes full advantage of the expertise across multiple institutions. The ACTC Coordinating Center will leverage the highly experienced teams in Clinical Operations, Data Systems and Management, and Biostatistics at USC. The MRI Unit, led by Mayo, and PET Unit, led by Harvard and UC Berkeley, will capitalize on unparalleled experience with multi-site protocols through ADNI, the A4 Study, and multiple ongoing clinical trials. The Clinical Outcome Instrument and Biomarkers Units will leverage world-class expertise from Mayo, Harvard, and USC to incorporate both standard and novel outcome measures in future trial designs. The new ACT E2-A2 Unit will provide training and leadership opportunities to young clinical investigators to facilitate continued innovation in trial design, and catalyze the next generation of AD clinical trials. Innovation in trial interventions, outcomes, design and analysis: the experts comprising this infrastructure provide the highest levels of expertise to design and conduct trials across the full continuum of AD, from primary prevention initiatives to combination trials for advanced symptomatic stages. We will build on our successes with public/private partnerships and continue to strengthen our strategic alliances to conduct large scale trials, while also supporting novel approaches to smaller investigator-initiated POC studies that will better inform Phase 3 decision-making. A program facilitating the longitudinal follow up of clinical trial participants with site assistance for brain donation, centralizing tissue banking and sharing is another key aim of the renewal.


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 = $29,438,964 )
2025	2025	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90033	LOS ANGELES	USA	Aging Research	001	8	9/3/2025	NON-COMPETING CONTINUATION	$29,438,964
2025	2024	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90033	LOS ANGELES	USA	Aging Research	000	7	6/5/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $29,438,964

Issue Date FY: 2024 ( Subtotal = $28,436,169 )
2024	2024	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90033	LOS ANGELES	USA	Aging Research	002	7	8/27/2024	NON-COMPETING CONTINUATION	$28,436,169
2024	2023	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90089	LOS ANGELES	USA	Aging Research	000	6	3/15/2024	COMPETING CONTINUATION	$0
2024	2022	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90033	LOS ANGELES	USA	Aging Research	001	5	8/6/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $28,436,169

Issue Date FY: 2023 ( Subtotal = $28,125,414 )
2023	2023	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST	LOS ANGELES	CA	90089	LOS ANGELES	USA	Aging Research	001	6	9/15/2023	COMPETING CONTINUATION	$28,125,414
2023	2022	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Aging Research	000	5	10/28/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $28,125,414

Issue Date FY: 2022 ( Subtotal = $16,738,113 )
2022	2022	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Aging Research	000	5	8/8/2022	NON-COMPETING CONTINUATION	$16,738,113
														Subtotal = $16,738,113

Issue Date FY: 2021 ( Subtotal = $17,032,916 )
2021	2021	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Aging Research	004	4	9/21/2021	SUPPLEMENT FOR EXPANSION	$230,541
2021	2021	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Aging Research	003	4	8/12/2021	NON-COMPETING CONTINUATION	$16,802,375
2021	2020	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Aging Research	001	3	12/15/2020	SUPPLEMENT FOR EXPANSION	$0
2021	2020	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Aging Research	000	3	12/14/2020	NON-COMPETING CONTINUATION	$0
2021	2020	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Aging Research	002	3	3/17/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $17,032,916

Issue Date FY: 2020 ( Subtotal = $16,895,428 )
2020	2020	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Aging Research	003	3	6/11/2020	SUPPLEMENT FOR EXPANSION	$0
2020	2020	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Aging Research	001	3	1/23/2020	NON-COMPETING CONTINUATION	$1,658,430
2020	2020	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Aging Research	002	3	5/6/2020	SUPPLEMENT FOR EXPANSION	$311,154
2020	2020	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Aging Research	000	3	12/30/2019	NON-COMPETING CONTINUATION	$14,925,844
														Subtotal = $16,895,428

Issue Date FY: 2019 ( Subtotal = $16,572,694 )
2019	2019	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Aging Research	001	2	12/11/2018	SUPPLEMENT FOR EXPANSION	$2,251,991
2019	2019	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Aging Research	002	2	8/31/2019	SUPPLEMENT FOR EXPANSION	$344,272
2019	2019	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Aging Research	000	2	11/19/2018	NON-COMPETING CONTINUATION	$13,976,431
														Subtotal = $16,572,694

Issue Date FY: 2018 ( Subtotal = $14,683,120 )
2018	2018	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER STREET THIRD FLOOR	LOS ANGELES	CA	90089	LOS ANGELES	USA	Aging Research	000	1	12/2/2017	NEW	$1,932,005
2018	2018	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Aging Research	002	1	9/18/2018	SUPPLEMENT FOR EXPANSION	$630,000
2018	2018	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Aging Research	001	1	6/29/2018	NEW	$12,121,115
														Subtotal = $14,683,120

Grand Total All Awards = $167,922,818

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Alzheimer's Clinical Trials Consortium (ACTC)

Award Number: U24AG057437

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 12/02/2017

PERIOD OF PERFORMANCE END DATE: 08/31/2028

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