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A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer's dementia
Xiao S, Chan P, Wang T, Hong Z, Wang S, Kuang W, He J, Pan X et al.. Alzheimer's research & therapy, 2021-03-17
Topic: Amyloid, tau and blood-test diagnosis
Background New therapies are urgently needed for Alzheimer's disease (AD). Sodium oligomannate (GV-971) is a marine-derived oligosaccharide with a novel proposed mechanism of action. The first phase 3 clinical trial of GV-971 has been completed in China. Methods We conducted a phase 3, double-blind, placebo-controlled trial in participants with mild-to-moderate AD to assess GV-971 efficacy and safety. Participants were randomized to placebo or GV-971 (900 mg) for 36 weeks. The primary outcome was the drug-placebo difference in change from baseline on the 12-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog12). Secondary endpoints were drug-placebo differences on the Clinician's Interview-Based Impression of Change with caregiver input (CIBIC+), Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, and Neuropsychiatric Inventory (NPI). Safety and tolerability were monitored. Results A total of 818 participants were randomized: 408 to GV-971 and 410 to placebo. A significant drug-placebo difference on the ADAS-Cog12 favoring GV-971 was present at each measurement time point, measurable at the week 4 visit and continuing throughout the trial. The difference between the groups in change from baseline was - 2.15 points (95% confidence interval, - 3.07 to - 1.23; p Conclusions GV-971 demonstrated significant efficacy in improving cognition with sustained improvement across all observation periods of a 36-week trial. GV-971 was safe and well-tolerated. Trial registration ClinicalTrials.gov, NCT0229391 5. Registered on November 19, 2014.
Key findings
- Results A total of 818 participants were randomized: 408 to GV-971 and 410 to placebo.
- A significant drug-placebo difference on the ADAS-Cog12 favoring GV-971 was present at each measurement time point, measurable at the week 4 visit and continuing throughout the trial.
- The difference between the groups in change from baseline was - 2.15 points (95% confidence interval, - 3.07 to - 1.23; p Conclusions GV-971 demonstrated significant efficacy in improving cognition with sustained improvement across all observation periods of a 36-week trial.
Why it matters
In this 36-week trial of 818 people with mild-to-moderate Alzheimer's dementia, those taking sodium oligomannate (GV-971) showed a significant difference in cognitive scores favoring the drug compared with placebo. The study reports this as an improvement in cognition, but it did not show that the drug cures or prevents Alzheimer's disease.
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Study details
- Study designclinical trial
- Participants818
- Evidence strengthHigh
How this study scored 74/100
Published in a peer-reviewed journal, and it is a large phase 3 trial. Scored zero for effect reported because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Alzheimer's research & therapy) |
| Journal's citation record | 1 / 4 | Alzheimer s Research & Therapy: journal h-index 146 (OpenAlex, 2026-10-29) |
| Study design | 11 / 12 | A large phase 3 trial (from PubMed type “Clinical Trial, Phase III”) |
| 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 | 2021 — within 6 year(s) of the newest study here |
| Sample size | 2 / 4 | 818 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | 5 / 7 | Cited 215 times (OpenAlex, 2026-10-10) |
| Citations per year | 4 / 5 | 30.7 citations a year over 7 year(s) since 2021 |
| Impact for its field and year | 4 / 6 | Cited 19.9× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 3 / 6 | Cited by 14 other studies in this library |
| Still being cited | 3 / 4 | Cited 103 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Zhenxin Zhang: h-index 28 (OpenAlex, whole career) |
| Institution's track record | 2 / 3 | Chinese Academy of Sciences: institution h-index 1,801 (OpenAlex) |
| Multi-centre collaboration | 3 / 3 | OpenAlex lists 47 institution(s) in 2 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 33731209) |
| Free to read | 2 / 2 | Free to read |
| Total | 74 / 100 | — |
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Read the original
- DOI: 10.1186/s13195-021-00795-7
- PubMed: 33731209
- Original source →
- Free full text: Alzheimer s Research & Therapy →
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
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
Xiao, S., Chan, P., Wang, T., Hong, Z., Wang, S., Kuang, W., et al. (2021). A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer's dementia. Alzheimer's research & therapy. https://doi.org/10.1186/s13195-021-00795-7
Vancouver
Xiao S, Chan P, Wang T, Hong Z, Wang S, Kuang W, et al. A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer's dementia. Alzheimer's research & therapy. 2021. doi:10.1186/s13195-021-00795-7. PMID: 33731209.
BibTeX
@article{xiao2021-33731209,
author = {Xiao, S. and Chan, P. and Wang, T. and Hong, Z. and Wang, S. and Kuang, W. and He, J. and Pan, X. and others},
title = {{A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer's dementia}},
journal = {Alzheimer's research \& therapy},
year = {2021},
doi = {10.1186/s13195-021-00795-7},
pmid = {33731209},
url = {https://doi.org/10.1186/s13195-021-00795-7}
}
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