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Evaluation of a selective PPAR-gamma agonist for treatment of Alzheimer?s Disease

Award Number: R43AG065069
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2019
PERIOD OF PERFORMANCE END DATE: 03/31/2021

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Evaluation of a selective PPAR-gamma agonist for treatment of Alzheimer?s Disease - PROJECT SUMMARY Alzheimer’s disease (AD) is the sixth leading cause of death in United States, yet this indication lacks truly effective therapeutics to mitigate this disease. To address this problem, a novel (partial) peroxisomal proliferator activating–gamma (PPAR) nuclear receptor agonist (AU-9) that has selective amino acid interactions in the receptor ligand-binding domain was developed. Preliminary data suggest AU-9 may reduce AD-related pathologies, including amyloid accumulation, neuro-inflammation, behavioral deficits and neurodegeneration (reduced neuronal plasticity). The goal of this current application is to further test and develop AU-9 in preparation to submit an IND application to the FDA to initiate clinical trials. Two aims are proposed to achieve this goal. Aim 1 will evaluate the effective concentration, absorption and distribution of AU-9 in rodent models of Alzheimer’s disease. The minimal concentration of AU-9 needed to improve neuronal plasticity will be determined by electrophysiological analysis. Maximum tolerated doses will also be assessed. Live-cell in vitro imaging will be used to validate preliminary data, support in vivo findings proposed herein and gain mechanistic insight to AU-9 effects. Finally, pharmacokinetic analysis and tissue distribution of AU-9 using LC-MS analysis will be performed in a dose and time dependent manner. Aim 2 will evaluate the safety of AU- 9 following long-term treatment in mice. Current full PPAR agonists produce unwanted side effects on the heart and liver. Potential adverse reactions of AU-9 will be observed (testing over a range of doses over 6 months) on both the heart and liver, organs normally adversely impacted with current clinical PPAR agonists. In addition, this aim will focus on key IND enabling data required by FDA guidelines, including measuring the effects of AU-9 on liver enzyme levels (CYP enzymes). The results of these studies are expected to confirm AU-9 as a potential treatment or preventive therapy for AD and ultimately support efforts to submit an IND application and initiate Phase I clinical trials testing AU-9.


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: 2021 ( Subtotal = -$3,094 )
2021	2020	OLEOLIVE, INC.	2031 KINGS HWY STE 236	SHREVEPORT	LA	71103	CADDO	USA	Aging Research	000	2	5/24/2021	NON-COMPETING CONTINUATION	-$3,094
														Subtotal = -$3,094

Issue Date FY: 2020 ( Subtotal = $103,008 )
2020	2020	OLEOLIVE, LLC	2031 KINGS HWY # 204	SHREVEPORT	LA	71103	CADDO	USA	Aging Research	000	2	5/20/2020	NON-COMPETING CONTINUATION	$103,008
														Subtotal = $103,008

Issue Date FY: 2019 ( Subtotal = $346,991 )
2019	2019	OLEOLIVE, LLC	2031 KINGS HWY # 204	SHREVEPORT	LA	71103	CADDO	USA	Aging Research	000	1	8/19/2019	NEW	$346,991
2019	2019	OLEOLIVE, LLC	2031 KINGS HWY # 204	SHREVEPORT	LA	71103	CADDO	USA	Aging Research	001	1	9/20/2019	NEW	$0
														Subtotal = $346,991

Grand Total All Awards = $446,905

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Evaluation of a selective PPAR-gamma agonist for treatment of Alzheimer?s Disease

Award Number: R43AG065069

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2019

PERIOD OF PERFORMANCE END DATE: 03/31/2021

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