Ambroxol as a disease-modifying treatment to reduce the risk of cognitive impairment in GBA -associated Parkinson's disease: a multicentre, randomised, double-blind, placebo-controlled, phase II trial. The AMBITIOUS study protocol.

Fabiana ColucciMicol AvenaliRosita De MiccoMarco Fusar PoliSilvia CerriMario StanzianoAna BacilaGiada CuconatoValentina FrancoDiego FranciottaCristina GhezziMatteo GastaldiAntonio Emanuele EliaLuigi RomitoGrazia DevigiliValentina LetaBarbara GaravagliaNico Golfrè AndreasiFederico CazzanigaChiara RealeCaterina GalandraGiancarlo GermaniPierfrancesco MitrottiGerardo OngariIlaria PalmieriMarta PicasciaAnna PichiecchioMattia VerriFabrizio EspositoMario CirilloFederica Di NardoSimone AloisioMattia SicilianoSara PrioniPaolo AmamiSylvie PiacentiniMaria Grazia BruzzoneMarina GrisoliFabio ModaRoberto EleopraAlessandro TessitoreEnza Maria ValenteRoberto Cilia

Published in: BMJ neurology open (2023)

NCT05287503, EudraCT 2021-004565-13.

Keyphrases

placebo controlled
double blind
study protocol
clinical trial
cognitive impairment
phase iii
phase ii
randomized controlled trial
open label
phase ii study
smoking cessation