Investigators propose a phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study to evaluate the safety, tolerability, and biomarker activity of 2-HOBA in 48 MCI/AD participants. Participants will be randomized 1:1:1:1 to receive 250, 500, 750 mg 2-HOBA acetate TID or placebo for 16 weeks. Blood and cerebral spinal fluid (CSF) will be collected to measure markers of protein modification by dicarbonyls (IsoLGs- & MDA), pTau-181, YKL-40, and NF-L.

Start Date01 Jul 2024

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MTI Biotech, Inc.

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100 Clinical Results associated with MTI Biotech, Inc.

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12 Apr 2022·Journal of Animal Science

PSII-19 Supplementing Calcium Beta-Hydroxy-Beta-Methylbutyrate (CAHMB) and Vitamin D3 to Sows Increases Piglet Weights

Author: Mohr, Mike ; Rathmacher, John A ; Fuller, John C

AbstractPrevious studies have shown that supplementing sows with calcium beta-hydroxy-beta-methylbutyrate (CaHMB) or CaHMB plus Vitamin D3 in late gestation and/or lactation improved piglet weight through weaning. This study was conducted at a commercial farrowing operation to confirm previous results, and 52 sows were studied, 26 in each of 2 groups. Sows were randomized to receive either 3 g/d CaHMB plus 500 IU/d Vitamin D3 (HMB/D) or a calcium carbonate containing control top-dressed to the morning ration from day 104 of gestation through weaning. Group 1 consisted of older sows, 4th and 5th parity, while Group 2 sows were younger, 2nd and 3rd parity. Three sows failed to farrow, 1 died after farrowing and 1 farrowed late, therefore forty-seven sows were included in the analysis. Treatment with HMB/D had no effect on sow weights, lactational weight loss, pre- or post-farrowing body condition score, stillborn piglets, mummified piglets, or number of piglets born alive or weaned. In both farrowing groups, birth and 24-hour weights of the piglets from HMB/D-supplemented sows were increased (P < 0.0001). Piglets from sows supplemented with HMB/D were 9.7% heavier at birth and at 24 hours were 9.2% heavier, 1,418.6±21.2 and 1,549.3±22.0 g in Control and HMB/D, respectively. Analysis of birth to weaning dates demonstrated that Control piglets were on average one-half day older than HMB/D piglets at weaning (P < 0.0001). However, adjusting the weaning weights to a standardized 21-d weight (5,205.6±99.5 and 5,423.9±103.5 g for Control and HMB/D piglets, respectively) did not demonstrate statistical significance (P = 0.13). Further analysis by group showed HMB/D tended to increase weaning weights in younger sows (Group 2), 5,073.7±142.7 in Controls, 5,431.7±150.7 g in HMB/D piglets (P < 0.09). In conclusion, our results agree with previous studies demonstrating CaHMB and HMB/D supplementation increased early piglet weights with a tendency to improve weaning weights.

01 Dec 2021·TrialsQ4 · MEDICINE

2-Hydroxybenzylamine (2-HOBA) to prevent early recurrence of atrial fibrillation after catheter ablation: protocol for a randomized controlled trial including detection of AF using a wearable device

Q4 · MEDICINE

ArticleOA

Author: Akers, Wendell S ; O'Neill, Matthew J ; Ye, Fei ; Murray, Katherine T ; Crawford, Diane M ; Ao, Mingfang ; Michaud, Gregory F ; Pitchford, Lisa M ; Rathmacher, John A ; Roden, Dan M ; Shoemaker, M Benjamin ; Yoneda, Zachary T

AbstractBackgroundAlthough catheter ablation is an effective therapy for atrial fibrillation (AF), the most common cardiac arrhythmia encountered in clinical practice, AF ablation generates inflammation and oxidative stress in the early postoperative period predisposing to recurrence of AF. Isolevuglandins (IsoLGs) are reactive lipid mediators of oxidative stress injury that rapidly react with endogenous biomolecules to compromise their function. 2-Hydroxybenzylamine (2-HOBA), a potent small molecule scavenger of IsoLGs, sequesters the reactive species as inert adducts. This mechanism, coupled with reported safety in humans, supports the investigation of 2-HOBA as a novel therapeutic to reduce AF caused by oxidative stress, such as that which occurs after catheter ablation. Accordingly, we seek to test the hypothesis that treatment with 2-HOBA will decrease early recurrence of AF and other atrial arrhythmias following AF ablation by decreasing IsoLG adducts with native biomolecules.MethodsThe proposed trial will randomly assign 162 participants undergoing cryo- or radiofrequency catheter ablation for AF to 2-HOBA (N = 81) or placebo (N = 81). Individuals will begin the study drug 3 days prior to ablation and continue for 28 days. Participants will be given a wearable smartwatch capable of detecting and recording atrial arrhythmias. They will be instructed to record ECGs daily with additional ECGs if they experience symptoms of AF or when alerted by the smartwatch AF detection alarm. The primary clinical endpoint will be an episode of AF, atrial tachycardia, or atrial flutter lasting 30 s or more within 28 days post-AF ablation. Secondary measures will be the change in IsoLG adduct levels from blood samples collected immediately pre-ablation and post-ablation and reduction in AF burden as calculated from the smartwatch.DiscussionThe proposed trial will test the hypothesis that 2-HOBA reduces post-ablation atrial arrhythmias through sequestration of reactive IsoLG species. The results of this study may improve the understanding of the role of IsoLGs and oxidative stress in AF pathogenesis and provide evidence to advance 2-HOBA and related compounds as a new therapeutic strategy to treat AF.Trial registrationClinicalTrials.gov NCT04433091. Registered on June 3, 2020.

07 May 2021·Journal of Animal Science

PSV-13 The Effect of Supplementing Sows with the Leucine Metabolite Beta-hydroxy-beta-methylbutyrate and Vitamin D3 Pre-parturition and During Lactation on Early Piglet Weight

Author: Chaves, Rhuan F ; Fuller, John C ; Castro, Fabricio ; Rathmacher, John A ; Mohr, Mike

AbstractAbstract: Several university studies supplementing calcium beta-hydroxy-beta-methylbutyrate (CaHMB) to sows have reported benefit to piglets such as a reduction in low birthweight piglets, increased piglet birth weight, and increased weaning weights. This study was designed to determine if these benefits would be observed in a commercial production setting using sows whose genetics are known for having a high number of piglets born, which generally results in lower average piglet birth weights. The study was conducted at a commercial farrow to finish operation (Patos de Minas, Minas Gerais, Brazil) and sows studies were randomly assigned to either CaHMB/D (n=41, 3 g CaHMB plus 500 IU Vitamin D3) or a control (n=46, Maltodextrin and CaCO3). Treatments were applied as a top-dress to the morning ration and were applied from 10 days pre-farrowing throughout the lactational period. The results were analyzed using GLM in SAS and Least Square Means±SEM were reported. Piglets from CaHMB/D-supplemented sows had a greater average live birth weights (1.39±0.027 versus 1.32±0.026 kg, respectively, p < 0.05) and 24-hour weights (1.48±0.029 versus 1.39±0.028 kg. respectively, p < 0.02). Normal farm practices were utilized in an attempt to equalize piglet numbers across sows by cross fostering piglets after 24 hours. After analysis of the data at the end of the study, the significant early weight advantage for CaHMB/D-supplemented pigs was eliminated during the cross-fostering process. After equalization, the 24-hour average piglet weights were not significantly different (1.53±0.041 versus 1.45±0.039 kg in CaHMB/D and control, respectively) and, therefore, further advantages to supplementation were not observed. Conclusion: This study would appear to support that feeding CaHMB/D in late gestation and early lactation can improve early piglet weights and further studies with controlled cross-fostering and monitoring individual piglet weight gain are necessary to confirm this advantage is continued throughout the lactation period and into the grower phase.

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