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ADVANCED COMPREHENSIVE MAGNETIC RESONANCE SOLUTION FOR THE NONINVASIVE CHARACTERIZATION OF HIGH RESOLUTION METABOLIC BIOMARKERS OF RISK IN PATIENTS WITH ALZHEIMER'S DISEASE AND DEMENTIA

Award Number: R44AG085817
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/20/2023
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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ADVANCED COMPREHENSIVE MAGNETIC RESONANCE SOLUTION FOR THE NONINVASIVE CHARACTERIZATION OF HIGH RESOLUTION METABOLIC BIOMARKERS OF RISK IN PATIENTS WITH ALZHEIMER'S DISEASE AND DEMENTIA - NIH SBIR Fast-Track, PAS-22-196 Advanced Comprehensive Magnetic Resonance Solution for the Non Invasive Characterization of No Clinical Trials High Resolution Metabolic Biomarkers of Risk in Patients with Alzheimer’s Disease and Dementia Project Summary This project addresses the Advancing Research on Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) Initiative of the National Institute on Aging (PAS-22-196). We propose to develop an advanced hardware-software package, ADRD360, to optimally acquire, process, and analyze magnetic resonance imaging (MRI) and spectroscopy (MRS) in the human brain. The ADRD360 will help to localize metabolic signatures and obtain MRI and MRS brain data at much higher resolutions than currently possible on clinical MR systems. Highly resolved MRI and MRS will be of utmost importance to aid in the early prediction of the risk of developing AD. The ADRD360 may lead to the early detection of structural and metabolic parameters as predictive diagnostic tool biomarkers in patients with AD, ADRD, other neurological disorders and psychiatric diseases. This project will offer a complete solution with the development and optimization of 1) advanced radio-frequency (RF) coils approaching ultimate intrinsic signal-to-noises (UISNRs) and acceptable specific absorption rates (SARs); 2) pushing structural MR imaging resolutions over commercial devices; 3) advancing shimming procedures to improve the homogeneity of the B0 field; 4) permitting high-resolution, multi-dimensional, multi-volume MRS exams with 100% structure-function correlation in reasonable scan times; 5) a stand-alone, easy-to-use program that provides the crucial link between multi-dimensional structural and multi-volume MRS acquisition, including its clinical and metabolic interpretation by effectively tackling the demanding spectral processing and analysis needs; and 6) a comprehensive MRI-MRS metrics system calibration, quality assurance and validation phantom essential to confirm reproducibility of measurements. Initially, we will demonstrate the research utility and clinical applicability by determining the structural and metabolic MRI-MRS parameter spread in healthy subjects. Results from this study will become essential to interpretation in subjects at higher risk of developing AD. This work builds upon our expertise in creating the first commercial dual- tuned 1H-31P 1.5T and 3T head coils (R44NS037273). This research also builds upon our work with the development of an automated B0 shimming program (FWHM 11.7 ± 1.9 Hz, n=94 at 1.5T) and the interactive MRS software. This project will offer 'A Complete Solution for the Early AD Detection’ with advanced brain MR assessments in the high-resolution structural and functional MRI exams, and multinuclear metabolic-based MRS acquisitions. Our licensed Siemens vendor agreement will propel the development and commercialization of the ADRD360. We aim to satiate the researchers by approaching the ultimate intrinsic SNR 31P and 1H limits on the 3T and 7T MR systems. We plan to demonstrate the clinical advantages by identifying critical structural and metabolic MR brain parameters that can be used as screening biomarkers in humans with mild cognitive impairment due to aging, AD, and related dementia. Confidential Proprietary Information Advanced Imaging Research dba SREE Medical Systems


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 = $1,275,000 )
2025	2025	ADVANCED IMAGING RESEARCH INC	4700 LAKESIDE AVE E STE 400	CLEVELAND	OH	44114	CUYAHOGA	USA	Aging Research	001	3	8/18/2025	NON-COMPETING CONTINUATION	$1,275,000
2025	2023	ADVANCED IMAGING RESEARCH INC	4700 LAKESIDE AVE E STE 400	CLEVELAND	OH	44114	CUYAHOGA	USA	Aging Research	000	1	3/31/2025	NEW	$0
														Subtotal = $1,275,000

Issue Date FY: 2024 ( Subtotal = $1,275,000 )
2024	2024	ADVANCED IMAGING RESEARCH INC	4700 LAKESIDE AVE E STE 400	CLEVELAND	OH	44114	CUYAHOGA	USA	Aging Research	000	2	8/26/2024	EXTENSION WITH OR WITHOUT FUNDS	$1,275,000
														Subtotal = $1,275,000

Issue Date FY: 2023 ( Subtotal = $569,853 )
2023	2023	ADVANCED IMAGING RESEARCH, INC.	4700 LAKESIDE AVE E UNIT 504A	CLEVELAND	OH	44114	CUYAHOGA	USA	Aging Research	000	1	9/18/2023	NEW	$569,853
														Subtotal = $569,853

Grand Total All Awards = $3,119,853

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ADVANCED COMPREHENSIVE MAGNETIC RESONANCE SOLUTION FOR THE NONINVASIVE CHARACTERIZATION OF HIGH RESOLUTION METABOLIC BIOMARKERS OF RISK IN PATIENTS WITH ALZHEIMER'S DISEASE AND DEMENTIA

Award Number: R44AG085817

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/20/2023

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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