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ASURE Clinical Trial Protocol: A Randomized, Placebo-Controlled, Proof-of-Concept Study Aiming to Evaluate Safety and Target Engagement following Administration of TW001 in Early Alzheimer's Disease Patients
Oosthoek M, Lili A, Almeida A, van Loosbroek O, van der Geest R, de Greef-van der Sandt I, van Bokhoven P, Sikkes SAM et al.. The journal of prevention of Alzheimer's disease, 2023-01-01
Topic: Amyloid, tau and blood-test diagnosis
Background Alzheimer's disease (AD) is a neurodegenerative disease with complex disease etiology and pathological processes. These include formation of plaques and tangles, aberrant lipid processing, neuroinflammation, cerebrovascular dysregulation, ion channel and mitochondrial dysfunction, and oxidative stress. Disease-modifying therapies focusing on all these different facets are needed. TW001 is an oral formulation with the radical scavenger edaravone as its active ingredient, targeting oxidative stress. Objectives This manuscript describes the trial design for Phase IIA Alzheimer Study Using oRal Edaravone (ASURE). Methods ASURE is a randomized, placebo-controlled, proof-of-concept study aiming to evaluate safety and target engagement following administration of TW001 in early AD patients. Patients should have a biomarker confirmed diagnosis to be included in the trial and will be treated for 90 days. The primary endpoints include safety and effect of TW001 on oxidative stress biomarkers. Exploratory endpoints focus on a panel of AD(-related) fluid-based biomarkers and EEG. In addition, a recently developed cognitive functional composite (CFC) score will measure early signs of cognitive and functional effects of TW001. Results This article outlines the design of the clinical study, no results are included. Conclusions The ASURE trial design is discussed, with a particular focus on fluid biomarkers, EEG, and CFC as endpoints. By testing multiple measures related to pathology, pharmacodynamics, EEG as proxy for cognition, and cognitive functional scores, it is expected that small changes will be detectable in trials of shorter duration. Moreover, the wide range of endpoints allows to make well-informed decisions for designing pivotal studies later.
Key findings
- Results This article outlines the design of the clinical study, no results are included.
Why it matters
This is a protocol for a proof-of-concept trial testing an oral edaravone formulation in early Alzheimer's disease patients. No results are included, so it is unknown whether the treatment is safe or effective.
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Study details
- Evidence strengthHigh
How this study scored 39/100
Published in a peer-reviewed journal. Scored zero for study design, sample size, effect reported and studied in people because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (The journal of prevention of Alzheimer's disease) |
| Journal's citation record | 0 / 4 | The Journal of Prevention of Alzheimer s Disease: journal h-index 63 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 3 / 5 | 2023 — within 6 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | 2 / 7 | Cited 8 times (OpenAlex, 2026-10-10) |
| Citations per year | 1 / 5 | 1.6 citations a year over 5 year(s) since 2023 |
| Impact for its field and year | 2 / 6 | Cited 1.2× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 1 / 4 | Cited 8 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Everard G.B. Vijverberg: h-index 20 (OpenAlex, whole career) |
| Institution's track record | 1 / 3 | Vrije Universiteit Amsterdam: institution h-index 1,014 (OpenAlex) |
| Multi-centre collaboration | 1 / 3 | OpenAlex lists 3 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 37874087) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 39 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
Full text: free to read — Unpaywall lists this copy as free to read: the link above (checked 10 Oct 2026).
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Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record's author list ends in “et al.”, so not every author is named. Check the citation against the original before you use it.
APA 7th
Oosthoek, M., Lili, A., Almeida, A., van Loosbroek, O., van der Geest, R., de Greef-van der Sandt, I., et al. (2023). ASURE Clinical Trial Protocol: A Randomized, Placebo-Controlled, Proof-of-Concept Study Aiming to Evaluate Safety and Target Engagement following Administration of TW001 in Early Alzheimer's Disease Patients. The journal of prevention of Alzheimer's disease. https://doi.org/10.14283/jpad.2023.107
Vancouver
Oosthoek M, Lili A, Almeida A, van Loosbroek O, van der Geest R, de Greef-van der Sandt I, et al. ASURE Clinical Trial Protocol: A Randomized, Placebo-Controlled, Proof-of-Concept Study Aiming to Evaluate Safety and Target Engagement following Administration of TW001 in Early Alzheimer's Disease Patients. The journal of prevention of Alzheimer's disease. 2023. doi:10.14283/jpad.2023.107. PMID: 37874087.
BibTeX
@article{oosthoek2023-37874087,
author = {Oosthoek, M. and Lili, A. and Almeida, A. and van Loosbroek, O. and van der Geest, R. and de Greef-van der Sandt, I. and van Bokhoven, P. and Sikkes, S. A. M. and others},
title = {{ASURE Clinical Trial Protocol: A Randomized, Placebo-Controlled, Proof-of-Concept Study Aiming to Evaluate Safety and Target Engagement following Administration of TW001 in Early Alzheimer's Disease Patients}},
journal = {The journal of prevention of Alzheimer's disease},
year = {2023},
doi = {10.14283/jpad.2023.107},
pmid = {37874087},
url = {https://doi.org/10.14283/jpad.2023.107}
}
Studies this one cites
Referenced by this study and also in the alzhub library, so you can read them here.