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Phase 2 study of palmitoylethanolamide combined with luteoline in frontotemporal dementia patients
Martina Assogna, Francesco Di Lorenzo, Sonia Bonnı̀, Ilaria Borghi, Emanuele Cerulli Irelli, Lucia Mencarelli, Michele Maiella, Marilena Minei et al.. Brain Communications, 2025-01-01
Topic: Brain proteins, microglia and lab models
In the last few years, co-ultramicronized palmitoylethanolamide combined with luteoline has emerged as a potential therapeutic molecule in neurodegenerative disorders pathogenically related to frontotemporal dementia, for its demonstrated strong anti-inflammatory and neuroprotective properties. Patients in the co-ultramicronized palmitoylethanolamide combined with luteoline group showed less decline for the primary outcome measure (CDR plus NACC FTLD) as compared with patients treated with placebo. Our results demonstrate that co-ultramicronized palmitoylethanolamide combined with luteoline shows promising efficacy in slowing down the progression of cognitive and functional symptoms in frontotemporal dementia patients. These findings warrant further investigation and offer potential for the development of effective therapeutic strategies for frontotemporal dementia.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Assogna, M., Di Lorenzo, F., Bonnı̀, S., Borghi, I., Irelli, E. C., Mencarelli, L., et al. (2025). Phase 2 study of palmitoylethanolamide combined with luteoline in frontotemporal dementia patients. Brain Communications. https://doi.org/10.1093/braincomms/fcaf080
Vancouver
Assogna M, Di Lorenzo F, Bonnı̀ S, Borghi I, Irelli EC, Mencarelli L, et al. Phase 2 study of palmitoylethanolamide combined with luteoline in frontotemporal dementia patients. Brain Communications. 2025. doi:10.1093/braincomms/fcaf080. PMID: 40046339.
BibTeX
@article{assogna2025-40046339,
author = {Assogna, Martina and Di Lorenzo, Francesco and Bonnı̀, Sonia and Borghi, Ilaria and Irelli, Emanuele Cerulli and Mencarelli, Lucia and Maiella, Michele and Minei, Marilena and others},
title = {{Phase 2 study of palmitoylethanolamide combined with luteoline in frontotemporal dementia patients}},
journal = {Brain Communications},
year = {2025},
doi = {10.1093/braincomms/fcaf080},
pmid = {40046339},
url = {https://doi.org/10.1093/braincomms/fcaf080}
}
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.
Key findings
- In the last few years, co-ultramicronized palmitoylethanolamide combined with luteoline has emerged as a potential therapeutic molecule in neurodegenerative disorders pathogenically related to frontotemporal dementia, for its demonstrated strong anti-inflammatory and neuroprotective properties.
- Patients in the co-ultramicronized palmitoylethanolamide combined with luteoline group showed less decline for the primary outcome measure (CDR plus NACC FTLD) as compared with patients treated with placebo.
- Our results demonstrate that co-ultramicronized palmitoylethanolamide combined with luteoline shows promising efficacy in slowing down the progression of cognitive and functional symptoms in frontotemporal dementia patients.
- These findings warrant further investigation and offer potential for the development of effective therapeutic strategies for frontotemporal dementia.
Why it matters
In a phase 2 clinical trial, patients with frontotemporal dementia taking co-ultramicronized palmitoylethanolamide combined with luteoline showed less decline on the primary outcome measure than those on placebo. The authors call the results promising but say further investigation is warranted before this can be considered an established treatment.
Study details
- Study designclinical trial
- Participants25
- Effect size47.9%
- Evidence strengthHigh
How this study scored 51/100
Published in a leading specialty journal. Scored zero for study design and randomised / blinded because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Brain Communications) |
| Journal's citation record | 0 / 4 | Brain Communications: journal h-index 67 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | Design recorded as “clinical trial”, which our rubric does not rank (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 | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 1 / 4 | 25 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 | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 2 / 7 | Cited 7 times (OpenAlex, 2026-10-10) |
| Citations per year | 1 / 5 | 2.3 citations a year over 3 year(s) since 2025 |
| Impact for its field and year | 3 / 6 | Cited 3.8× 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 7 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 3 / 4 | Last-listed author Giacomo Koch: h-index 83 (OpenAlex, whole career) |
| Institution's track record | 1 / 3 | Sapienza University of Rome: institution h-index 1,145 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 8 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 40046339) |
| Free to read | 2 / 2 | Free to read |
| Total | 51 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
- DOI: 10.1093/braincomms/fcaf080
- PubMed: 40046339
- Original source →
- Free full text: Brain Communications →
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
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