Monday, January 13, 2025 1/13/2025

Clinical Research in ALS and Related Disorders for Therapeutic Development (CReATe)

Award Number: U54NS092091
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary / Abstract The Clinical Research in ALS and related disorders for Therapy Development (CReATe) Consortium is a Rare Diseases Clinical Research Consortium (RDCRC) that forms part of the National Institutes of Health Rare Diseases Clinical Research Network (RDCRN). CReATe comprises a multi-disciplinary group of clinicians, scientists, educators, patient advocacy groups and other strategic partners, and aims to advance therapeutic development for patients with amyotrophic lateral sclerosis (ALS) and related disorders including progressive muscular atrophy (PMA), primary lateral sclerosis (PLS), frontotemporal dementia (FTD), multisystem proteinopathy (MSP), and hereditary spastic paraplegia (HSP). We recognize that the obstacles to therapeutic development are multifactorial and include: (a) etiological and biological heterogeneity; (b) phenotypic heterogeneity; (c) limitations of existing clinical outcome measures for use in early-to-mid phase clinical trials; (d) a paucity of biomarkers that have been validated as “fit for purpose”); (e) the relatively late stage at which symptoms appear, diagnosis is made, and treatment is initiated; and (f) variable (often low) rates of patient participation in clinical research studies. CReATe investigators are engaged in a range of clinical trial readiness activities that aim to overcome these obstacles, and to thereby advance therapeutic development for this group of rare diseases. In addition, CReATe aims to promote and support collaborative research in the field of ALS and related disorders; develop and disseminate resources such as the CReATe Biorepository and our electronic health record-based ALS Toolkit that are of value to the broader scientific community; lower barriers to patient participation in research; cultivate and enhance the careers of young clinical investigators and translational scientists dedicated to the study of this group of rare diseases; and engage both lay- and scientific-community stakeholders in a partnership that fosters efforts to develop treatments for patients afflicted with these rare diseases.


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 = $0 )
2025	2023	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	10	11/14/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	10	7/16/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $1,518,603 )
2023	2023	UNIVERSITY OF MIAMI	1400 NW 10TH AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	10	9/13/2023	NON-COMPETING CONTINUATION	$1,518,603
2023	2022	UNIVERSITY OF MIAMI	1400 NW 10TH AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	9	4/17/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,518,603

Issue Date FY: 2022 ( Subtotal = $1,536,996 )
2022	2022	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	9	8/19/2022	NON-COMPETING CONTINUATION	$1,536,996
2022	2021	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	7	11/11/2021	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $1,536,996

Issue Date FY: 2021 ( Subtotal = $1,750,172 )
2021	2021	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	007	8	8/23/2021	NON-COMPETING CONTINUATION	$1,555,588
2021	2021	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	009	8	9/14/2021	NON-COMPETING CONTINUATION	$0
2021	2021	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	006	7	8/13/2021	SUPPLEMENT FOR EXPANSION	$194,584
2021	2021	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	008	8	9/10/2021	NON-COMPETING CONTINUATION	$0
2021	2019	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	6	4/7/2021	COMPETING CONTINUATION	-$13,438
2021	2019	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	003	6	4/7/2021	COMPETING CONTINUATION	-$788,796
2021	2019	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	005	6	4/14/2021	COMPETING CONTINUATION	$804,059
2021	2018	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	4/7/2021	NON-COMPETING CONTINUATION	$788,796
2021	2018	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	004	5	4/14/2021	NON-COMPETING CONTINUATION	-$804,059
2021	2018	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	5	4/7/2021	NON-COMPETING CONTINUATION	$13,438
														Subtotal = $1,750,172

Issue Date FY: 2020 ( Subtotal = $1,633,874 )
2020	2020	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	005	7	8/20/2020	NON-COMPETING CONTINUATION	$1,633,874
2020	2019	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	004	6	3/24/2020	COMPETING CONTINUATION	$802,234
2020	2019	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	6	11/14/2019	COMPETING CONTINUATION	$0
2020	2019	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	6	11/20/2019	COMPETING CONTINUATION	$0
2020	2018	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	5	11/27/2019	NON-COMPETING CONTINUATION	$0
2020	2018	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	003	5	3/24/2020	NON-COMPETING CONTINUATION	-$802,234
														Subtotal = $1,633,874

Issue Date FY: 2019 ( Subtotal = $1,725,519 )
2019	2019	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	6	9/18/2019	COMPETING CONTINUATION	$1,725,519
														Subtotal = $1,725,519

Issue Date FY: 2018 ( Subtotal = $1,238,576 )
2018	2018	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	8/24/2018	NON-COMPETING CONTINUATION	$1,238,576
														Subtotal = $1,238,576

Issue Date FY: 2017 ( Subtotal = $1,850,283 )
2017	2017	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	003	4	8/10/2017	SUPPLEMENT FOR EXPANSION	$150,331
2017	2017	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	7/3/2017	NON-COMPETING CONTINUATION	$1,252,817
2017	2017	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	4	7/19/2017	SUPPLEMENT FOR EXPANSION	$299,785
2017	2017	UNIVERSITY OF MIAMI	1600 NW 10 AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	4	7/20/2017	SUPPLEMENT FOR EXPANSION	$147,350
														Subtotal = $1,850,283

Issue Date FY: 2016 ( Subtotal = $1,253,670 )
2016	2016	UNIVERSITY OF MIAMI	P.O. BOX 248106	CORAL GABLES	FL	33124	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	6/30/2016	NON-COMPETING CONTINUATION	$1,253,670
														Subtotal = $1,253,670

Issue Date FY: 2015 ( Subtotal = $1,261,491 )
2015	2015	UNIVERSITY OF MIAMI	P.O. BOX 248106	CORAL GABLES	FL	33124	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	7/2/2015	NON-COMPETING CONTINUATION	$1,261,491
														Subtotal = $1,261,491

Issue Date FY: 2014 ( Subtotal = $1,235,166 )
2014	2014	UNIVERSITY OF MIAMI	P.O. BOX 248106	CORAL GABLES	FL	33124	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	9/25/2014	NEW	$1,235,166
														Subtotal = $1,235,166

Grand Total All Awards = $15,004,350

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Clinical Research in ALS and Related Disorders for Therapeutic Development (CReATe)

Award Number: U54NS092091

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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