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A Program for Innovative PET Radioligand Development and Application - A Translational Toolbox for Treatments for Mental Health

Award Number: U01MH107803
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/24/2015
PERIOD OF PERFORMANCE END DATE: 05/31/2027

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A Program for Innovative PET Radioligand Development and Application - A Translational Toolbox for Treatments for Mental Health - Project Summary/Abstract Advances in molecular neuroscience, genetics, and basic behavioral science have vastly expanded our knowledge and understanding on the etiology and pathophysiology of mental illness, and identified new molecular targets for therapeutic development. PET imaging has similarly expanded dramatically and now provides critical translational tools for molecular imaging and therapeutic development in mental disorders. PET imaging with target-specific radioligands has played a critical role in the elucidation of molecular targets, such as receptors and transporters for the dopamine, serotonin, opioid, GABA, glutamate, endocannabinoid, and acetylcholine systems, in the pathophysiology of depression, schizophrenia, and other mental disorders. The availability of suitable radioligands is key to exploring the full potential of PET imaging in mental health research. The goal of this renewal application is to advance an innovative program in the development, validation, and application of novel PET radioligands to probe high priority molecular targets implicated in mental health disorders. This program builds on the Yale PET Center's outstanding capability in radioligand development and clinical evaluation. We use a tiered development strategy: Tier 1 - Chemistry development and in vitro testing; Tier 2 - In vivo assessment in non-human primates; Tier 3 – First-in-human proof of concept/validation studies; and Tier 4 - Application to investigate mechanisms of mental illnesses. Radioligands enter the development scheme at any tier when there is sufficient rationale that advancing the radioligand can inform disease mechanisms of relevant mental disorders. The program's External Scientific Panel and Steering Committee (NIMH program leaders, industry and academic subject-matter experts, and Yale scientists) hold annual meetings to nominate new targets and review ongoing data to optimize the radioligand pipeline. Radioligands developed and data generated under the program are disseminated via a dedicated website, conference presentations and publications, and shared with the PET imaging and mental health research community. This program aligns tightly with NIMH priorities by involvement of NIMH program officers in the decision- making process, and engages the entire PET tracer development and imaging community in the common endeavor to validate novel radioligands for molecular targets important in mental health research. The initial funding cycle resulted in the validation of a novel agonist tracer for the dopamine D1 receptor, the first-in-human testing of radiotracers for histone deacetylase 6 (HDAC6) and monoacylglycerol lipase (MAGL), and most significantly, the development of first-in-class radiotracers for the GABA transporter-1 (GAT-1), and best-in-class radiotracer for the GluN2B subunit of the NMDA receptor complex, which we propose to translate to first-in- human evaluation in this renewal application. Success in the next cycle will see validation of first-in-class and best-in-class radiotracers for imaging and quantification of GAT-1, GluN2B, and AMPA receptors in humans, and development of novel radiotracers for new targets to advance mental health research through PET imaging.


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 = $1,590,284 )
2025	2025	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	002	9	7/25/2025	NON-COMPETING CONTINUATION	$1,590,284
2025	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	8	1/27/2025	NON-COMPETING CONTINUATION	$957,435
2025	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	001	8	4/23/2025	NON-COMPETING CONTINUATION	-$957,435
														Subtotal = $1,590,284

Issue Date FY: 2024 ( Subtotal = $1,590,284 )
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	8	6/6/2024	NON-COMPETING CONTINUATION	$1,590,284
														Subtotal = $1,590,284

Issue Date FY: 2023 ( Subtotal = $1,590,284 )
2023	2023	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	003	7	9/16/2023	NON-COMPETING CONTINUATION	$0
2023	2023	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	002	7	6/15/2023	NON-COMPETING CONTINUATION	$1,590,284
2023	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	001	6	4/25/2023	COMPETING CONTINUATION	$951,896
2023	2020	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	5	4/25/2023	NON-COMPETING CONTINUATION	-$951,896
														Subtotal = $1,590,284

Issue Date FY: 2022 ( Subtotal = $1,583,584 )
2022	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	003	6	9/19/2022	COMPETING CONTINUATION	$1,583,584
2022	2020	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	002	5	9/13/2022	NON-COMPETING CONTINUATION	$0
2022	2020	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	5	11/17/2021	NON-COMPETING CONTINUATION	$0
2022	2020	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	001	5	6/23/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,583,584

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	5	3/31/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $1,254,722 )
2020	2020	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	004	5	6/23/2020	NON-COMPETING CONTINUATION	$1,254,722
2020	2019	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	003	4	5/8/2020	NON-COMPETING CONTINUATION	$0
2020	2018	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	002	3	4/22/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,089,065
2020	2016	MOLECULAR NEUROIMAGING, LLC	60 TEMPLE ST STE 8A	NEW HAVEN	CT	06510	SOUTH CENTRAL CT	USA	Mental Health Research Grants	001	2	4/22/2020	NON-COMPETING CONTINUATION	-$969,027
2020	2015	MOLECULAR NEUROIMAGING, LLC	60 TEMPLE ST STE 8A	NEW HAVEN	CT	06510	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	1	4/22/2020	NEW	-$120,038
														Subtotal = $1,254,722

Issue Date FY: 2019 ( Subtotal = $1,255,992 )
2019	2019	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	4	8/20/2019	NON-COMPETING CONTINUATION	$1,255,992
														Subtotal = $1,255,992

Issue Date FY: 2018 ( Subtotal = $1,246,997 )
2018	2018	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	001	3	8/21/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,246,997
2018	2016	MOLECULAR NEUROIMAGING, LLC	60 TEMPLE ST STE 8A	NEW HAVEN	CT	06510	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	2	8/21/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,246,997

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2016	MOLECULAR NEUROIMAGING, LLC	60 TEMPLE ST STE 8A	NEW HAVEN	CT	06510	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	2	8/3/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $969,027 )
2016	2016	MOLECULAR NEUROIMAGING LLC	60 TEMPLE STREET	NEW HAVEN	CT	06510	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	2	9/16/2016	NON-COMPETING CONTINUATION	$969,027
														Subtotal = $969,027

Issue Date FY: 2015 ( Subtotal = $1,076,696 )
2015	2015	MOLECULAR NEUROIMAGING LLC	60 TEMPLE STREET	NEW HAVEN	CT	06510	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	1	9/24/2015	NEW	$1,076,696
														Subtotal = $1,076,696

Grand Total All Awards = $12,157,870

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A Program for Innovative PET Radioligand Development and Application - A Translational Toolbox for Treatments for Mental Health

Award Number: U01MH107803

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/24/2015

PERIOD OF PERFORMANCE END DATE: 05/31/2027

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