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1. Rationale and study design of a randomized, placebo-controlled, double-blind phase 2b trial to evaluate efficacy, safety, and tolerability of an oral glutaminyl cyclase inhibitor varoglutamstat (PQ912) in study participants with MCI and mild AD—VIVIAD

Author

E. G. B. Vijverberg, T. M. Axelsen, A. R. Bihlet, K. Henriksen, F. Weber, K. Fuchs, J. E. Harrison, K. Kühn-Wache, P. Alexandersen, N. D. Prins, and Philip Scheltens

Subjects
Alzheimer, Clinical trials, Small molecules, Puroglutamate, Abeta, Placebo, Amyloid, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571, Neurology. Diseases of the nervous system, RC346-429
Abstract

Abstract Background Varoglutamstat (formerly PQ912) is a small molecule that inhibits the activity of the glutaminyl cyclase to reduce the level of pyroglutamate-A-beta (pGluAB42). Recent studies confirm that pGluAB42 is a particular amyloid form that is highly synaptotoxic and plays a significant role in the development of AD. Methods This paper describes the design and methodology behind the phase 2b VIVIAD-trial in AD. The aim of this study is to evaluate varoglutamstat in a state-of-the-art designed, placebo-controlled, double-blind, randomized clinical trial for safety and tolerability, efficacy on cognition, and effects on brain activity and AD biomarkers. In addition to its main purpose, the trial will explore potential associations between novel and established biomarkers and their individual and composite relation to disease characteristics. Results To be expected early 2023 Conclusion This state of the art phase 2b study will yield important results for the field with respect to trial methodology and for the treatment of AD with a small molecule directed against pyroglutamate-A-beta. Trial registration ClinicalTrials.gov Identifier: NCT04498650

Published
2021
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2. Rationale and study design of a randomized, placebo-controlled, double-blind phase 2b trial to evaluate efficacy, safety, and tolerability of an oral glutaminyl cyclase inhibitor varoglutamstat (PQ912) in study participants with MCI and mild AD—VIVIAD

Author

K. Kühn-Wache, Philip Scheltens, J. E. Harrison, K. Henriksen, K. Fuchs, T. M. Axelsen, Everard G. B. Vijverberg, P. Alexandersen, A. R. Bihlet, Niels D. Prins, F. Weber, Amsterdam Neuroscience - Neurodegeneration, and Neurology

Subjects
Oncology, medicine.medical_specialty, Amyloid, Neurology, Cognitive Neuroscience, Neurosciences. Biological psychiatry. Neuropsychiatry, Placebo, law.invention, Double blind, Double-Blind Method, Randomized controlled trial, Alzheimer Disease, law, Internal medicine, medicine, Humans, RC346-429, Trial methodology, business.industry, Research, Glutaminyl cyclase, Aminoacyltransferases, Clinical trial, Treatment Outcome, Tolerability, Clinical trials, Small molecules, Puroglutamate, Alzheimer, Abeta, Neurology (clinical), Neurology. Diseases of the nervous system, business, RC321-571
Abstract

Background Varoglutamstat (formerly PQ912) is a small molecule that inhibits the activity of the glutaminyl cyclase to reduce the level of pyroglutamate-A-beta (pGluAB42). Recent studies confirm that pGluAB42 is a particular amyloid form that is highly synaptotoxic and plays a significant role in the development of AD. Methods This paper describes the design and methodology behind the phase 2b VIVIAD-trial in AD. The aim of this study is to evaluate varoglutamstat in a state-of-the-art designed, placebo-controlled, double-blind, randomized clinical trial for safety and tolerability, efficacy on cognition, and effects on brain activity and AD biomarkers. In addition to its main purpose, the trial will explore potential associations between novel and established biomarkers and their individual and composite relation to disease characteristics. Results To be expected early 2023 Conclusion This state of the art phase 2b study will yield important results for the field with respect to trial methodology and for the treatment of AD with a small molecule directed against pyroglutamate-A-beta. Trial registration ClinicalTrials.gov Identifier: NCT04498650

Published
2021

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