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Central and peripheral immune cross-talk in Alzheimer's disease and their modulation by a novel immunotherapy

Award Number: R01AG077685
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/01/2023
PERIOD OF PERFORMANCE END DATE: 12/31/2026

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Central and peripheral immune cross-talk in Alzheimer's disease and their modulation by a novel immunotherapy - Project Summary/Abstract Alzheimer’s disease (AD) gene-risk data, epidemiological findings and animal models converge to indicate the critical role of inflammation for the onset and progression of AD. Inflammation could provide a new focus for therapeutic intervention. However, inflammation biomarkers are poorly characterized in AD. In this project, we will measure blood and cerebrospinal fluid (CSF) inflammation biomarkers and compare them to measurements of brain glial activation obtained by positron emission tomography (PET). In addition, we will determine the effect of low-dose interleukin-2 (IL-2) immunotherapy, given over 22 weeks, on these inflammation biomarkers. For this purpose, we will measure these biomarkers in AD individuals enrolled in a phase 2a safety and efficacy trial of low-dose IL-2 therapy. Regulatory T cells (Tregs) play a neuroprotective role by suppressing inflammation in the blood and the brain. We have shown that Treg immunomodulatory mechanisms are compromised in AD patients, resulting in activation of pro-inflammatory monocytes and upregulation of inflammatory mediators. In a Phase 1 clinical study, we showed that IL-2 administration induced Treg expansion and restoration; the therapy was safe, and it was associated with improved cognition. Supported by a “Part-the-Cloud” grant from the Alzheimer’s Association, we will conduct a follow up phase 2a study which includes the measurement of cognition, as well as CSF T-tau, P-tau, Aβ42, and neurofilament light chain (NFL) before and after 22 weeks of IL-2 treatment in the subjects with mild to moderate AD. Taking advantage of this novel trial, and by evaluating the 40 AD patients participating in it, the current study will investigate systemic and central nervous system (CNS) biomarkers of inflammation and their modulation by IL-2 administration. We will analyze the impact of IL-2 immunotherapy on peripheral immune biomarkers (Aim 1) as well as CNS inflammation, measured through CSF inflammation biomarkers (Aim 2) and brain inflammation positron emission tomography (Aim 3). To determine which blood biomarkers correlate best with central nervous system biomarkers (Aim 4), the associations among blood, CSF, and brain imaging measures of neuroinflammation before and after IL-2 therapy will be determined. Our novel approach will explore the potential link between systemic and CNS inflammation in AD clinical setting and advance the use of inflammatory biomarkers in AD anti- inflammatory clinical trials.


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: 2026 ( Subtotal = $0 )
2026	2025	THE METHODIST HOSPITAL RESEARCH INSTITUTE	6565 FANNIN ST STE D200	HOUSTON	TX	77030	HARRIS	USA	Aging Research	000	3	10/21/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $644,840 )
2025	2025	METHODIST HOSPITAL, THE	6670 BERTNER AVE	HOUSTON	TX	77030	HARRIS	USA	Aging Research	001	3	8/12/2025	NON-COMPETING CONTINUATION	$52,639
2025	2025	METHODIST HOSPITAL, THE	6670 BERTNER AVE	HOUSTON	TX	77030	HARRIS	USA	Aging Research	000	3	2/14/2025	NON-COMPETING CONTINUATION	$592,201
														Subtotal = $644,840

Issue Date FY: 2024 ( Subtotal = $651,539 )
2024	2024	METHODIST HOSPITAL, THE	6670 BERTNER AVE	HOUSTON	TX	77030	HARRIS	USA	Aging Research	001	2	5/17/2024	NON-COMPETING CONTINUATION	$65,152
2024	2024	METHODIST HOSPITAL, THE	6670 BERTNER AVE	HOUSTON	TX	77030	HARRIS	USA	Aging Research	000	2	12/28/2023	NON-COMPETING CONTINUATION	$586,387
														Subtotal = $651,539

Issue Date FY: 2023 ( Subtotal = $651,539 )
2023	2023	METHODIST HOSPITAL, THE	6670 BERTNER AVE	HOUSTON	TX	77030	HARRIS	USA	Aging Research	001	1	3/10/2023	NEW	$0
2023	2023	METHODIST HOSPITAL, THE	6670 BERTNER AVE	HOUSTON	TX	77030	HARRIS	USA	Aging Research	000	1	12/30/2022	NEW	$651,539
														Subtotal = $651,539

Grand Total All Awards = $1,947,918

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Central and peripheral immune cross-talk in Alzheimer's disease and their modulation by a novel immunotherapy

Award Number: R01AG077685

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 01/01/2023

PERIOD OF PERFORMANCE END DATE: 12/31/2026

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