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A phase II randomized trial of sodium oligomannate in Alzheimer's dementia
Tao Wang, Weihong Kuang, Wei Chen, Wenwei Xu, Liming Zhang, Yingjie Li, Hailin Li, Ying Peng et al.. Alzheimer's research & therapy, 2020-09-14
Topic: Drug trials: efficacy and safety
Comparing with the placebo group (n = 83, change - 1.45), the ADAS-cog12 score change in the GV-971 600-mg group (n = 76) was - 1.39 (p = 0.89) and the GV-971 900-mg group (n = 83) was - 2.58 (p = 0.30). The treatment responders according to CIBIC-Plus assessment were significantly higher in the GV-971 900-mg group than the placebo group (92.77% vs. 79.52%, p < 0.05). The GV-971 900-mg subgroup showed a lower decline of cerebral metabolic rate for glucose than the placebo subgroup at the left precuneus, right posterior cingulate, bilateral hippocampus, and bilateral inferior orbital frontal at uncorrected p = 0.05. The respective rates of treatment-related AEs were 5.9%, 14.3%, and 3.5%. GV-971 was safe and well tolerated. GV-971 900 mg was chosen for phase III clinical study. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01453569 . Registered on October 18, 2011.
Key findings
- Comparing with the placebo group (n = 83, change - 1.45), the ADAS-cog12 score change in the GV-971 600-mg group (n = 76) was - 1.39 (p = 0.89) and the GV-971 900-mg group (n = 83) was - 2.58 (p = 0.30).
- The treatment responders according to CIBIC-Plus assessment were significantly higher in the GV-971 900-mg group than the placebo group (92.77% vs. 79.52%, p < 0.05).
- The GV-971 900-mg subgroup showed a lower decline of cerebral metabolic rate for glucose than the placebo subgroup at the left precuneus, right posterior cingulate, bilateral hippocampus, and bilateral inferior orbital frontal at uncorrected p = 0.05.
- The respective rates of treatment-related AEs were 5.9%, 14.3%, and 3.5%.
- GV-971 900 mg was chosen for phase III clinical study.
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Study details
- Participants83
- Effect size92.77%; 79.52%; 5.9%
- Evidence strengthHigh
How this study scored 78/100
Published in a peer-reviewed journal, and it is a randomised controlled trial. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record and free to read, so those were left out: it earned 46 of the 59 points we could judge it on, which is 78 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Alzheimer's research & therapy) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| 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 | 2 / 5 | 2020 — within 10 year(s) of the newest study here |
| Sample size | 1 / 4 | 83 participants |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 1 / 2 | Randomised (as stated in the record) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 32928279) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 46 / 59 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 46 of the 59 points we could judge it on is 78 out of 100. |
| Total | 78 / 100 | — |
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APA 7th
Wang, T., Kuang, W., Chen, W., Xu, W., Zhang, L., Li, Y., et al. (2020). A phase II randomized trial of sodium oligomannate in Alzheimer's dementia. Alzheimer's research & therapy. https://doi.org/10.1186/s13195-020-00678-3
Vancouver
Wang T, Kuang W, Chen W, Xu W, Zhang L, Li Y, et al. A phase II randomized trial of sodium oligomannate in Alzheimer's dementia. Alzheimer's research & therapy. 2020. doi:10.1186/s13195-020-00678-3. PMID: 32928279.
BibTeX
@article{wang2020-32928279,
author = {Wang, Tao and Kuang, Weihong and Chen, Wei and Xu, Wenwei and Zhang, Liming and Li, Yingjie and Li, Hailin and Peng, Ying and others},
title = {{A phase II randomized trial of sodium oligomannate in Alzheimer's dementia}},
journal = {Alzheimer's research \& therapy},
year = {2020},
doi = {10.1186/s13195-020-00678-3},
pmid = {32928279},
url = {https://doi.org/10.1186/s13195-020-00678-3}
}