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Oral PRI-002 treatment in patients with MCI or mild AD: a randomized, double-blind phase 1b trial
Kutzsche J, Cosma NC, Kauselmann G, Fenski F, Bieniek C, Bujnicki T, Pils M, Bannach O et al.. Nature communications, 2025-05-06
Topic: Drug trials: efficacy and safety
Overall, the study drug was well tolerated. No significant changes in clinical chemistry, hematology or hematoserology were detected. ECG, EEG and MRI revealed no changes and in detail no ARIA were observed. Furthermore, no significant changes were detected in p-tau, t-tau, Aβ 1-40, Aβ 1-42 and Aβ oligomers in CSF. Patients receiving PRI-002 performed significantly better than those receiving placebo in the CERAD word list at Day 56 (P ≤ 0.05). In conclusion, 28 days of treatment with 300 mg q.d.
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APA 7th
Kutzsche, J., Cosma, N. C., Kauselmann, G., Fenski, F., Bieniek, C., Bujnicki, T., et al. (2025). Oral PRI-002 treatment in patients with MCI or mild AD: a randomized, double-blind phase 1b trial. Nature communications. https://doi.org/10.1038/s41467-025-59295-z
Vancouver
Kutzsche J, Cosma NC, Kauselmann G, Fenski F, Bieniek C, Bujnicki T, et al. Oral PRI-002 treatment in patients with MCI or mild AD: a randomized, double-blind phase 1b trial. Nature communications. 2025. doi:10.1038/s41467-025-59295-z. PMID: 40324978.
BibTeX
@article{kutzsche2025-40324978,
author = {Kutzsche, J. and Cosma, N. C. and Kauselmann, G. and Fenski, F. and Bieniek, C. and Bujnicki, T. and Pils, M. and Bannach, O. and others},
title = {{Oral PRI-002 treatment in patients with MCI or mild AD: a randomized, double-blind phase 1b trial}},
journal = {Nature communications},
year = {2025},
doi = {10.1038/s41467-025-59295-z},
pmid = {40324978},
url = {https://doi.org/10.1038/s41467-025-59295-z}
}
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Key findings
- Overall, the study drug was well tolerated.
- No significant changes in clinical chemistry, hematology or hematoserology were detected.
- ECG, EEG and MRI revealed no changes and in detail no ARIA were observed.
- Furthermore, no significant changes were detected in p-tau, t-tau, Aβ 1-40, Aβ 1-42 and Aβ oligomers in CSF.
- Patients receiving PRI-002 performed significantly better than those receiving placebo in the CERAD word list at Day 56 (P ≤ 0.05).
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Study details
- Participants20
- Evidence strengthHigh
How this study scored 84/100
Published in a leading specialty journal, and it is a randomized controlled trial. Scored zero for effect reported because the record does not state it. 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 multicenter collaboration, so those were left out: it earned 49 of the 58 points we could judge it on, which is 84 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Nature communications) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 11 / 12 | A randomized 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 | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 1 / 4 | 20 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) |
| Randomized / blinded | 2 / 2 | Randomized and blinded or placebo-controlled (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 |
| Multicenter collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 40324978) |
| Free to read | 2 / 2 | Free to read |
| Points | 49 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 49 of the 58 points we could judge it on is 84 out of 100. |
| Total | 84 / 100 | — |
What each of these 20 components measures, and what this score is not →
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