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

Assogna M, Di Lorenzo F, Bonnì S, Borghi I, Cerulli Irelli E, Mencarelli L, Maiella M, Minei M, Esposito R, Casula EP, Pezzopane V, D'Acunto A, Porrazzini F, Candeo F, Ferraresi M, Motta C, Ferrari C, Caltagirone C, Martorana A, Koch G. Brain Communications, 2025; 7(2):fcaf080.

Randomised controlled trialHumansWith luteolin

This study tested palmitoylethanolamide together with luteolin. Its results cannot be assigned to palmitoylethanolamide alone. More combination studies.

Design

Randomised controlled trial

Subjects

48 patients with frontotemporal dementia randomised at one centre (25 treatment, 23 placebo). 45 completed.

Dose used in the study

700 mg of palmitoylethanolamide with 70 mg of luteolin, twice a day

Duration

24 weeks

What was measured

Change in the CDR plus NACC FTLD Sum of Boxes score as the main outcome. Daily living, language, behaviour and cognition scales.

What the authors reported

The main score worsened by 0.53 points in the treatment group versus 1.39 points in the placebo group (difference 0.86, 95% CI 0.28 to 1.45, P = 0.005). Daily living and language scores also declined less in the treatment group. Four other scales, including the MMSE, showed no significant difference. Adverse events were mild and similar between groups.

Limits of this study

One centre and 48 patients. The authors report that the primary endpoint was modified after the trial began, and that the pandemic disrupted the study. No biomarkers were measured. The study was funded by the Italian Ministry of Health and partly by Epitech Group, which makes the product. The senior author declared payments from Epitech.

Source

doi:10.1093/braincomms/fcaf080

Entry checked against the full text at the publisher (Oxford Academic) on 2026-09-21. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.