This preprint is under consideration at Alzheimer's Research and Therapy. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
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Research Article
Philip Scheltens
Amsterdam Universitair Medische Centra
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1046-6408
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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 VIVIAD-trial. The aim of this study is to evaluate varoglutamstat in a state-of-the-art phase 2b, placebo-controlled, double-blind, randomized clinical trial on safety and tolerability, efficacy on cognition, 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 and the treatment of AD with a small molecule directed against pyroglutamate-A-beta.
Keywords
Alzheimer, clinical trials; small molecules; puroglutamate, abeta, placebo, amyloid
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CURRENT STATUS: Under Review
Version 1
Posted 09 Mar, 2021
No community comments so far
Reviewer #2 agreed
On 21 Mar, 2021
Reviewer #1 agreed
On 16 Mar, 2021
Review #? received
Received 16 Mar, 2021
Reviewers invited
Invitations sent on 03 Mar, 2021
Editor assigned
On 03 Mar, 2021
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On 03 Mar, 2021
Editor invited
On 03 Mar, 2021
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This preprint is under consideration at Alzheimer's Research and Therapy. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research Article
Philip Scheltens
Amsterdam Universitair Medische Centra
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1046-6408
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 09 Mar, 2021
No community comments so far
Reviewer #2 agreed
On 21 Mar, 2021
Reviewer #1 agreed
On 16 Mar, 2021
Review #? received
Received 16 Mar, 2021
Reviewers invited
Invitations sent on 03 Mar, 2021
Editor assigned
On 03 Mar, 2021
Submission checks complete
On 03 Mar, 2021
Editor invited
On 03 Mar, 2021
First submitted
On 03 Mar, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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 VIVIAD-trial. The aim of this study is to evaluate varoglutamstat in a state-of-the-art phase 2b, placebo-controlled, double-blind, randomized clinical trial on safety and tolerability, efficacy on cognition, 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 and the treatment of AD with a small molecule directed against pyroglutamate-A-beta.
Figure 1
Figure 2
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