Scientific Publications
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
Susan Abushakra, P. Murali Doraiswamy, John A. Hey, Duygu Tosun, Frederik Barkhof, Jerome Barakos, Jeffrey Petrella, J. Patrick Kesslak, Aidan Power, Marwan Sabbagh, Anton Porsteinsson, Sharon Cohen, Serge Gauthier, Craig Ritchie, David Watson, Emer McSweeney, Merce Boada, Earvin Liang, Luc Bracoud, Rosalind McLaine, Susan Flint, Jean F. Schaefer, Jeremy Yu, Margaret Bray, Suzanne Hendrix, Sam Dickson, Abe Durrant, Adem Albayrak & Martin Tolar
Clinical Efficacy, Safety and Imaging Effects of Oral Valiltramiprosate in APOE4/4 Homozygotes with Early Alzheimer’s Disease: Results of the Phase III, Randomized, Double-Blind, Placebo-Controlled, 78-Week APOLLOE4 Trial
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
Polymorph Analysis of ALZ-801 (Valiltramiprosate), a Valine-Conjugated Oral Prodrug of Tramiprosate in Late-Stage Clinical Development for Alzheimer’s Disease
D. Pearson, J. Amedio, J. F. Schaefer, M. Tolar & J. A. Hey
Clinical Pharmacokinetics of Oral ALZ-801/Valiltramiprosate in a 2-Year Phase 2 Trial of APOE4 Carriers with Early Alzheimer’s Disease
John A. Hey, Jeremy Y. Yu, Susan Abushakra, Jean F. Schaefer, Aidan Power, Pat Kesslak, Jijo Paul & Martin Tolar
Point of view: Challenges in implementation of new immunotherapies for Alzheimer’s disease
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
APOLLOE4 Phase 3 study of oral ALZ-801/valiltramiprosate in APOE ε4/ε4 homozygotes with early Alzheimer’s disease: Trial design and baseline characteristics
Susan Abushakra, Anton P. Porsteinsson, Marwan Sabbagh, David Watson, Aidan Power, Earvin Liang, Emer MacSweeney, Merce Boada, Susan Flint, Rosalind McLaine, J. Patrick Kesslak, John A. Hey, Martin Tolar
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
John A. Hey, Jeremy Y. Yu, Susan Abushakra, Jean F. Schaefer, Aidan Power, Patrick Kesslak & Martin Tolar
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
John A. Hey, Susan Abushakra, Kaj Blennow, Eric M. Reiman, Jakub Hort, Niels D. Prins, Katerina Sheardova, Patrick Kesslak, Larry Shen, Xinyi Zhu, Adem Albayrak, Jijo Paul, Jean F. Schaefer, Aidan Power & Martin Tolar
The Single Toxin Origin of Alzheimer’s Disease and Other Neurodegenerative Disorders Enables Targeted Approach to Treatment and Prevention
Martin Tolar, John Hey, Aidan Power, Susan Abushakra
Neurotoxic Soluble Amyloid Oligomers Drive Alzheimer’s Pathogenesis and Represent a Clinically Validated Target for Slowing Disease Progression
Martin Tolar, John Hey, Aidan Power, Susan Abushakra
APOE ε4/ε4 homozygotes with early Alzheimer’s disease show accelerated hippocampal atrophy and cortical thinning that correlates with cognitive decline
Susan Abushakra, Anton P. Porsteinsson, Marwan Sabbagh, Luc Bracoud, Joel Schaerer, Aidan Power, [...]
Aducanumab, gantenerumab, BAN2401, and ALZ-801 – the first wave of amyloid targeting drugs for Alzheimer’s disease with potential for near term approval
Martin Tolar, Susan Abushakra, John A. Hey, Anton Porsteinsson and Marwan Sabbagh
The path forward in Alzheimer’s disease therapeutics: Reevaluating the amyloid cascade hypothesis
Martin Tolar, Susan Abushakra, Marwan Sabbagh
Discovery and Identification of an Endogenous Metabolite of Tramiprosate and its Prodrug ALZ-801 that Inhibits Beta Amyloid Oligomer Formation In Human Brain
John A. Hey, Petr Kocis, Jakub Hort, Susan Abushakra, Aidan Power, Martin Vyhnálek, Jeremy Y. Yu & Martin Tolar
Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease
John A. Hey, Jeremy Y. Yu, Mark Versavel, Susan Abushakra, Petr Kocis, Aidan [...]
Clinical Effects Of Tramiprosate In APOE4/4 Homozygous Patients With Mild Alzheimer’s Disease Suggest Disease Modification Potential
S. Abushakra, A. Porsteinsson, P. Scheltens, C. Sadowsky, B. Vellas, J. Cummings, S. [...]
Elucidating the Aβ42 Anti-Aggregation Mechanism of Action of Tramiprosate in Alzheimer’s Disease: Integrating Molecular Analytical Methods, Pharmacokinetic and Clinical Data
Petr Kocis, Martin Tolar, Jeremy Yu, William Sinko, Soumya Ray, Kaj Blennow, Howard Fillit, John A. Hey
Clinical Benefits of Tramiprosate in Alzheimer’s Disease Are Associated with Higher Number of APOE4 Alleles: The “APOE4 Gene-Dose Effect”
S. Abushakra, A. Porsteinsson, B.Vellas, J. Cummings, S. Gauthier, J.A. Hey, A. Power, [...]
Efficacy of tramiprosate in APOE4 heterozygous patients with mild to moderate AD: combined sub-group analyses from two Phase 3 trials
Martin Tolar, Bruno Vellas, Jeffrey Cummings, Anton Porsteinsson, Susan Abushakra, Aidan Power, Jeremy Yu, John A. Hey
Tramiprosate, an oral amyloid anti-aggregation agent, shows robust cognitive efficacy in APOE4/4 homozygous AD patients: efficacy and safety analyses from two Phase 3 trials
Susan Abushakra, Bruno Vellas, Jeffrey Cummings, Jakub Hort, Anton Porsteinsson, John A. Hey, Aidan Power, Martin Tolar
Cognitive and Functional Efficacy of Tramiprosate in APOE4+ Patients with Mild to Moderate Alzheimer’s Disease: Subgroup Analyses of the Phase 3 North American and European Trials
John A. Hey, Jeremy Yu, Martin Tolar, Menghis Bairu, and John Sampalis
Analyses of tramiprosate Phase 3 trials show improvement in cognition and function in APOE4 positive alzheimer’s disease subjects reaching 4 point improvement from placebo on ADAS-cog in homozygous APOE4 subjects, and support development of ALZ-801, a novel prodrug of tramiprosate with optimized drug properties
J.A. Hey, M. Versavel, J. Sampalis, J.Y. Yu, P.H. Reinhart, J. Cummings, Miia Kipivelto, M. Bairu and M. Tolar
