Publications2024-07-29T15:59:32-04:00

Scientific Publications

28Sep, 2025

Clinical Efficacy, Safety and Imaging Effects of Oral Valiltramiprosate in APOE4/4 Homozygotes with Early Alzheimer’s Diseae: Results of the Phase III, Randomized, Double-Blind, Placebo-Controlled,78-Week APOLLOE4 Trial

September 28th, 2025|Categories: Publications|

Susan Abushakra, Aidan Power, David Watson, Anton Porsteinsson, Marwan Sabbagh, Emer MacSweeney, Sharon Cohen, Mercè Boada Rovira, P. Murali Doraiswamy, Earvin Liang, Susan Flint, J. Patrick Kesslak, Rosalind McLaine, Adem Albayrak, Jean Schaefer, Jeremy Yu, Luke Tolar, Sam Dickson, John A. Hey & Martin Tolar

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1Jan, 2025

Point of view: Challenges in implementation of new immunotherapies for Alzheimer’s disease

January 1st, 2025|Categories: Publications|

Sandar Aye, Gunilla Johansson, Christoph Hock, Lars Lannfelt, John R Sims, Kaj Blennow, Kristian S Frederiksen, Caroline Graffa, José Luis Molinuevo, Philip Scheltens, Sebastian Palmqvist, Michael Schöll, Anders Wimo, Miia Kivipelto, Ron Handels, Lutz Frölich, Norbert Zilka, Martin Tolar, Peter Johannsen, Linus Jönsson, Bengt Winblad

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Key Alzheon Publications

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Summary of Peer Reviewed Scientific Publications

  1. Abushakra S, et al: Hippocampal Atrophy on Magnetic Resonance Imaging as a Surrogate Marker for Clinical Benefit and Neurodegeneration in Early Symptomatic Alzheimer’s Disease: Synthesis of Evidence from Observational and Interventional Trials, Drugs, 2025.

  2. Abushakra S, et al: Clinical Efficacy, Safety and Imaging Effects of Oral Valiltramiprosate in APOEε4/ε4 Homozygotes with Early Alzheimer’s Disease: Results of the Phase III, Randomized, Double-Blind, Placebo-Controlled, 78-Week APOLLOE4 Trial, Drugs, 2025; 85(11): 1455–1472.

  3. Pearson D, et al: Polymorph Analysis of ALZ-801 (Valiltramiprosate), a Valine-Conjugated Oral Prodrug of Tramiprosate in Late-Stage Clinical Development for Alzheimer’s Disease, Journal of Chemical Crystallography, 2025; 55: 206–215.

  4. Hey JA, et al: Clinical Pharmacokinetics of Oral ALZ-801/Valiltramiprosate in a Two-Year Phase 2 Trial of APOE4 Carriers with Early Alzheimer’s Disease, Clinical Pharmacokinetics, 2025; 64(3):407-424.

  5. Aye S, et al: Point of View: Challenges in Implementation of New Therapies for Alzheimer’s Disease, The Journal of Prevention of Alzheimer’s Disease, 2025; 12(1):100022.

  6. Abushakra S, et al: APOLLOE4 Phase 3 Study of Oral ALZ-801/Valiltramiprosate in APOE ε4/ε4 Homozygotes with Early Alzheimer’s Disease: Trial Design and Baseline Characteristics, Alzheimer’s & Dementia 2024; 10(3): e12498.

  7. Tolar M, et al: The Single Toxin Origin of Alzheimer’s Disease and Other Neurodegenerative Disorders Enables Targeted Approach to Treatment and Prevention, International Journal of Molecular Sciences, Special Issue Dementia: From Molecular Pathophysiology to Novel Therapeutic Approaches 2024; 25(5): 2727.

  8. Hey JA et al: Analysis of Cerebrospinal Fluid, Plasma β‑Amyloid Biomarkers, and Cognition from a 2‑Year Phase 2 Trial Evaluating Oral ALZ‑801/Valiltramiprosate in APOE4 Carriers with Early Alzheimer’s Disease Using Quantitative Systems Pharmacology Model, Drugs 2024; 84(7): 825-839.

  9. Hey JA et al: Effects of Oral ALZ‑801/Valiltramiprosate on Plasma Biomarkers, Brain Hippocampal Volume, and Cognition: Results of 2‑Year Single‑Arm, Open‑Label, Phase 2 Trial in APOE4 Carriers with Early Alzheimer’s Disease, Drugs 2024; 84(7): 811-823.

  10. Tolar M, et al: Neurotoxic Soluble Amyloid Oligomers Drive Alzheimer’s Pathogenesis and Represent a Clinically Validated Target for Slowing Disease Progression, International Journal of Molecular Sciences, Special Issue Alzheimer’s Disease: Role and Structure of Soluble Oligomers 2021; 22(12): 6355.

  11. Abushakra S, et al: APOE ε4/ε4 Homozygotes with Early Alzheimer’s Disease Show Accelerated Hippocampal Atrophy and Cortical Thinning that Correlates with Cognitive Decline, Alzheimer’s & Dementia 2020; 6(1): e12117.

  12. Tolar M, et al: Aducanumab, Gantenerumab, BAN2401, and ALZ-801—the First Wave of Amyloid-Targeting Drugs for Alzheimer’s Disease with Potential for Near Term Approval, Alzheimer’s Research & Therapy, 2020; 12(1): 95.

  13. Tolar M, et al: The Path Forward in Alzheimer’s Disease Therapeutics: Reevaluating the Amyloid Cascade Hypothesis, Alzheimer’s & Dementia, 2020; 16(11):1553-1560.

  14. Hey JA, et al: Discovery and Identification of an Endogenous Metabolite of Tramiprosate and Its Prodrug ALZ-801 that Inhibits Beta Amyloid Oligomer Formation in the Human Brain, CNS Drugs, 2018; 32(9): 849-861.

  15. Hey JA, et al: Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease, Clinical Pharmacokinetics, 2018; 57(3): 315–333.

  16. Abushakra S, et al: Clinical Effects of Tramiprosate in APOE4/4 Homozygous Patients with Mild Alzheimer’s Disease Suggest Disease Modification Potential, The Journal of Prevention of Alzheimer’s Disease, 2017; 4(3): 149-156.

  17. Kocis P, et al: Elucidating the Aβ42 Anti-Aggregation Mechanism of Action of Tramiprosate in Alzheimer’s Disease: Integrating Molecular Analytical Methods, Pharmacokinetic and Clinical Data, CNS Drugs, 2017; 31(6): 495-509.

  18. Abushakra S, et al: Clinical Benefits of Tramiprosate in Alzheimer’s Disease Are Associated with Higher Number of APOE4 Alleles: The “APOE4 Gene-Dose Effect,” The Journal of Prevention of Alzheimer’s Disease, 2016; 3(4): 219-228.

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