Evidence map›Paper›PMID 40046339›Full record

Trial reportBrain communications2025

Phase 2 study of palmitoylethanolamide combined with luteoline in frontotemporal dementia patients.

Martina Assogna, Francesco Di Lorenzo, Sonia Bonnì, Ilaria Borghi, Emanuele Cerulli Irelli, Lucia Mencarelli, Michele Maiella, Marilena Minei, Romina Esposito, Elias P Casula and 10 more

Abstract readClinical Trial
In one paragraph

Trial report in Brain communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Natural Molecules for Brain Health and Resilience.International journal of molecular sciences · 2026
    Review
  3. Review
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Martina AssognaDepartment of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS, Rome 00179, Italy.
Francesco Di LorenzoDepartment of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS, Rome 00179, Italy.
Sonia BonnìDepartment of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS, Rome 00179, Italy.
Ilaria BorghiDepartment of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS, Rome 00179, Italy.
Emanuele Cerulli IrelliDepartment of Human Neurosciences, Sapienza, University of Rome, Rome 00185, Italy.
Lucia MencarelliDepartment of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS, Rome 00179, Italy.
Michele MaiellaDepartment of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS, Rome 00179, Italy.
Marilena MineiDepartment of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS, Rome 00179, Italy.
Romina EspositoDepartment of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS, Rome 00179, Italy.
Elias P CasulaDepartment of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS, Rome 00179, Italy.
Valentina PezzopaneDepartment of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS, Rome 00179, Italy.
Alessia D'AcuntoDepartment of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS, Rome 00179, Italy.
Francesco PorrazziniDepartment of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS, Rome 00179, Italy.
Francesca CandeoDepartment of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS, Rome 00179, Italy.
Matteo FerraresiDepartment of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS, Rome 00179, Italy.
Caterina MottaDepartment of Systems Medicine, University of Tor Vergata, Rome 00133, Italy.
Clarissa FerrariOffice of Research and Clinical Trials, Fondazione Poliambulanza Istituto Ospedaliero, Brescia 25124, Italy.
Carlo CaltagironeDepartment of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS, Rome 00179, Italy.
Alessandro MartoranaDepartment of Systems Medicine, University of Tor Vergata, Rome 00133, Italy.
Giacomo KochDepartment of Clinical and Behavioural Neurology, Santa Lucia Foundation IRCCS, Rome 00179, Italy.ORCID https://orcid.org/0000-0001-6155-9439

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Frontotemporal dementia is a devastating neurodegenerative disorder for which no pharmacological treatments have been approved. Neuroinflammation plays a central role in driving the pathogenic mechanisms underlying frontotemporal dementia. 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. Here we wanted to determine whether treatment with co-ultramicronized palmitoylethanolamide combined with luteoline may have a clinical impact in frontotemporal dementia patients. We performed a Phase 2, monocentric, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of co-ultramicronized palmitoylethanolamide combined with luteoline in frontotemporal dementia patients. Forty eight patients with a diagnosis of probable frontotemporal dementia were randomly assign in a 1:1 ratio to receive co-ultramicronized palmitoylethanolamide combined with luteoline oral suspension at the dosage of 700 mg + 70 mg twice/day (

Indexed as

cognitive declinefrontotemporal dementianeuroinflammationpalmitoylethanolamidesynaptic activity

Identifiers

PMID40046339
PMCPMC11881584

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.