Dopaminergic Therapy for Frontotemporal Dementia Patients

Summary

This is a phase IIa 24-week randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy and safety of Rotigotine (RTG) transdermal administration at the dosage of 4 mg or 6 mg per day versus Placebo (PLC) in newly diagnosed behavioural Frontotemporal Dementia (bvFTD) patients. 75 patients with a diagnosis of probable bvFTD will be randomly allocated to the 3 treatment arms (RTG 4mg/day, RTG 6mg/day or PLC), with 25 patients per group. Clinical and neurophysiological measurements and brain metabolism via FDG-PET will be collected before and after drug administration.

Timeline

Start

2021-06-03

Primary completion

2023-12-30

Completion

2024-04-01

Outcome

Missed primary endpoint

paper rotigotine 4 mg vs placebo, -0.90; 95% CI -2.22 to 0.42; p = 0.18 PMID 40809903 ↗

paper rotigotine 6 mg vs placebo, -0.19; 95% CI -1.52 to 1.14; p = 0.77 PMID 40809903 ↗

Publications

• Koch G, Assogna M, Gadola Y, Alberici A, Di Lorenzo F, Bonni S, Borghi I, Cerulli Irelli E, Mencarelli L, Maiella M, Esposito R, Casula EP, Pezzopane V, D'Acunto A, Candeo F, Ferraresi M, Guerrera G, Battistini L, Premi E, Bracca V, Lucchini S, Bertagna F, Romano P, Ludovici A, Daniele A, Motta C, Ferrari C, Martorana A, Borroni B. Safety and efficacy of rotigotine in patients with frontotemporal dementia: a phase 2, double-blind, randomized, placebo-controlled, multicenter trial. Lancet Reg Health Eur. 2025 Aug 5;57:101409. doi: 10.1016/j.lanepe.2025.101409. eCollection 2025 Oct.

Drugs

Indications