Alzamend Neuro, Inc. · NASDAQ:ALZN
Alzamend Neuro — ISMRM Workshop Advances in X-Nuclei MR 2026
17 slides from Alzamend Neuro's conference presentation, Sep 29, 2026
Slide 1: Pharmacokinetics imaging of lithium at 7T – results from a phase 1/2A clinical trial
DEPARTMENT OF RADIOLOGY Pharmacokinetics imaging of lithium at 7T – results from a phase 1/2A clinical trial with a novel organic lithium salt Massachusetts General Hospital HARVARD Medical School Ovidiu C. Andronesi , Katherine N. Maina, Daniel Park, May Aon, Shuqing Deng, Melanie Brown, Sara Farin
Slide 2: Declaration of Financial Interests or Relationships
Speaker Name: Ovidiu C. Andronesi I have the following financial interest or relationship to disclose with regard to the subject matter of this presentation : • Company Name: Alzamend Neuro Inc • Type of Relationship: Sponsored research funding Declaration of Financial Interests or Relationships ISM
Slide 3: Lithium Treatment
3 • Lithium is the gold standard treatment for bipolar disorder , and often used in major depressive disorder, schizophrenia or Alzheimer’s disease. • Clinical utility is constrained by a narrow therapeutic window for inorganic lithium salts (Li 2 CO 3 ) which need careful monitoring to manage renal
Slide 4: AL001
AL001 4 4 AL001 = co - crystal of Lithium salicylate + L - proline (LISPRO crystal) Pre - clinical studies in mice indicated a better PK profile for lithium salicylate Smith A et al, RSC Adv., 2014, 4, 12362 – 12365
Slide 5: Clinical Trial Design
5 CLINICAL TRIAL DESIGN Baseline MRI (1x) Baseline Plasma (1x) Period1 MRI (7x) Period1 Plasma (28x) Period2 MRI (7x) Period2 Plasma (28x) 30 Participants: • 6 Healthy • 6 Bipolar • 6 Major Depression • 6 Alzheimer • 6 PTSD Phase 1/2a design: • 2 treatments • 2 periods • randomized • longitudinal •
Slide 6: Lithium Imaging
6 LITHIUM IMAGING • MR Scanner: 7T Terra.X (Siemens Healthineers) • Dual - tuned coil: 7Li/1H 1Tx/1Tx - 16Rx/16Rx (Tesla Dynamics Coil) • Pulse sequence: 3D radial balanced SSFP (3D bSSFP) • Image reconstruction: Regridding + density compensation (ICE on - line) • Image processing: Super - resolutio
Slide 7: Image Processing Pipeline
IMAGE PROCESSING PIPELINE YK
Slide 8: Image Processing Pipeline
8 IMAGE PROCESSING PIPELINE Xianqi Li et al, Radiology 2020, 294, 589 - 597 ܠ ො ൌ ܽݎ݃ ‹ ሼ ܠ ܡ െ ܪ ሺ ܠ ሻ ଶ ࣅ ܴ ሺ ܠ ሻ ሽ ܴ ܠ ൌ ܠ ܞ െ ܟ ሺ ܞ ǡ ܝ ሻ ܠ ܝ ܝ א π ሺ ܞ ሻ ଶ ܞ Low - res MRSI High - res MRI Super - res MRSI Super - resolution: regularized patch based feature nonlocal means Absolute Quantif
Slide 9: Phantom Validation: Spatial Resolution
9 PHANTOM VALIDATION Lithium image spatial resolution of 3D radial bSSFP
Slide 10: Phantom Validation: Absolute Quantification
10 PHANTOM VALIDATION Absolute Quantification of Li concentration from bSSFP images Variability: test - retest triplicates Linearity and lower limit of quantitation
Slide 11: Rating of Li Image Quality by Radiologists
11 Rating of Li Image Quality by Radiologists Gwet’s Agreement Coefficient Agreement Analysis Landis - Koch Benchmark Label Estimate (95%CI) Substantial 0.73 (0.66, 0.80) Primary Analysis - assuming complete independence Moderate - Fair 0.61 (0.28, 0.83) Sensitivity Analysis - not assuming complete
Slide 12: Lithium Brain Concentration
12 Lithium Brain Concentration Baseline AL001 Li 2 CO 3 1 0 mM 1 0 mM 1 0 mM [Li] in GM and WM [mM]
Slide 13: Voxel-wise General Linear Model
13 Voxel - wise General Linear Model [Li] Treatment - Baseline 2 1.3 - Log 10 (p) AL001 - Baseline Li 2 CO 3 - Baseline 2 1.3 - Log 10 (p)
Slide 14: PK analysis – non-compartmental model
14 PK analysis – non - compartmental model [Li] plasma [Li] white matter [Li] gray matter AUC AL001 = 53873 ( hr *ng/mL) AUC Li 2 CO 3 = 51427 ( hr *ng/mL) AUC AL001 = 32370.77 ( hr *ng/mL) AUC Li 2 CO 3 = 29309.12 ( hr *ng/mL) ) AUC AL001 = 37347.73 ( hr *ng/mL) AUC Li 2 CO 3 = 33581.70 ( hr *ng/mL
Slide 15: PK analysis – two-compartments model
15 PK analysis – two - compartments model K1 (ml/cm 3 /min) 3 0 ml/cm 3 /min
Slide 16: Summary
Summary 16 » 7 Tesla provides higher SNR for lithium imaging and allows quantification of lithium concentration in the brain over the PK relevant range ( 0 . 1 - 1 mM ; 694 - 6941 ng/g) with anatomical spatial resolution . » Brain region analysis indicate a trend for slightly higher Li concentration
Slide 17: Acknowledgements
Acknowledgements MGH, Department of Radiology Martinos Biomedical Imaging Center: Katherine Maina Paul Weiser Tan - Hanh Pham Nathaniel Mercaldo May Aon Shuqing Deng Melanie Brown Sarah Farina Hope Taft Susie Huang Bruce Rosen MGH, Department of Psychiatry: Steven Arnold Michael Henry MGH, Clinical
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