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18Sep, 2024

New Peer-Reviewed Scientific Publication Describes Study Design and Baseline Characteristics from APOLLOE4 Phase 3 Trial of Oral ALZ-801/Valiltramiprosate in APOE4/4 Homozygous Individuals with Early Alzheimer’s Disease

September 18th, 2024|

APOLLOE4 is the first interventional AD drug trial focused on APOE4/4 homozygotes, a population enriched with amyloid pathology in brain parenchyma and small vessels – a condition called cerebral amyloid angiopathy

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Key Alzheon Publications

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Summary of Peer Reviewed Scientific Publications

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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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