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Article History

Received: 5 December 2024

Accepted: 4 March 2025

First Online: 2 April 2025

Declarations

:

: The study was conducted in a research hospital in Italy (Santa Lucia Foundation IRCCS). The trial was approved by the review board and the local ethics committee of the Santa Lucia Foundation IRCCS (Prot. CE/Prog.716) in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonisation Good Clinical Practice guidelines. All patients or their relatives or legal representatives provided written informed consent. Patients could withdraw at any point without prejudice. This report followed the CONSORT reporting guideline for randomized studies. The study was registered on the clinicaltrial.gov website on 07–07-2022 (NCT05454540). An independent committee monitored the patients' safety according to the Data Monitoring Committee Charter.

: Not applicable.

: GK is scientific co-founder and holds stocks of Sinaptica Therapeutics. GK has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from: Epitech, Roche, Novo Nordisk. GK and AM have the following patent issued: Combination drug formulations including rotigotine and an acetylcholinesterase inhibitor for the treatment of neurodegenerative diseases (n. 20230381512); GK and ES have the following patent issued: Systems and methods for providing personalized targeted non-invasive stimulation to a brain network (n. 11998740). GK reports grants from Epitech, Alzheimer’s Drug Discovery Foundation, Italian Ministry of Health and non-financial support from UCB Pharma outside the submitted work. ES is is scientific co-founder and holds stocks of Sinaptica Therapeutics. AM reports grants from Alzheimer’s Drug Discovery Foundation, Italian Ministry of Health and non-financial support from UCB Pharma outside the submitted work.