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Ambroxol, a small molecule widely used for respiratory diseases, has emerged as a potential therapeutic agent for PD, acting by increasing GCase activity. A phase 2 trial demonstrated ambroxol\u2019s safety and efficacy in penetrating cerebrospinal fluid (CSF) and engaging with its target in PD patients, including those with\n                      <jats:italic>GBA1<\/jats:italic>\n                      variants.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We present the protocol of the ASPro-PD trial, a phase 3, multicentre, randomised, double-blind, placebo-controlled trial, aimed at evaluating whether high-dose ambroxol improves motor and non-motor function in PD patients. The trial will enrol 330 PD patients with confirmed\n                      <jats:italic>GBA1<\/jats:italic>\n                      status and the primary outcome will be the combined score of parts I, II, and III of the Movement Disorders Society\u2013Unified Parkinson\u2019s Disease Rating Scale (MDS-UPDRS). The secondary outcomes include safety, impact on PD symptoms, and quality of life. Mechanistic and exploratory outcomes include biomarkers related to GCase activity, blood, and CSF biomarkers.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This trial is the largest to date to study the effect of ambroxol in PD, utilise a genetically stratified PD population and will provide robust estimates of the efficacy of ambroxol in slowing PD clinical progression.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00415-026-13683-7","type":"journal-article","created":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T17:51:59Z","timestamp":1771437119000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Protocol of ASPro-PD: a phase 3 trial of ambroxol to slow progression in genetically stratified Parkinson\u2019s disease"],"prefix":"10.1007","volume":"273","author":[{"given":"Marco","family":"Toffoli","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisa","family":"Menozzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mairead","family":"Cullen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kashfia","family":"Chowdhury","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saiam","family":"Ahmed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nick","family":"Freemantle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joy","family":"Duffen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard K.","family":"Wyse","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon R. 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EM holds a NHS England medical post and her salary is paid in part by UCL. MC holds a FTE trial management position and is paid in full by UCL. KC has no financial disclosures. SA has no financial disclosures. NF has consulted with Sanofi Aventis, Agenx, ALK, and sits on a DSMB for Orion. JD is an employee of Cure Parkinson\u2019s. RKW is an employee of Cure Parkinson\u2019s. SRWS is an employee of Cure Parkinson\u2019s. HM is an employee of Cure Parkinson\u2019s. DD is an employee of Cure Parkinson\u2019s. FI has no financial disclosures. JM has no financial disclosures. PW holds a NHS England medical post. TF has received grants from National Institute of Health Research, Edmond J Safra Foundation, Michael J Fox Foundation, John Black Charitable Foundation, Cure Parkinson\u2019s, Innovate UK, Janet Owens Research Fellowship, Van Andel Research Institute and Defeat MSA. He has served on Advisory Boards for Peptron, Abbvie, Bluerock, Bayer & Bial. He has received honoraria for talks sponsored by Bayer, Bial & Novo Nordisk. KK is employed by the University of Rochester, and has grant support from the Michael J Fox Foundation, and is employed by BlueRidge Life Sciences. He has equity interests in BlueRidge, Modality.ai, Photopharmics, Vima Therapeutics, and Hoover Brown LLC. OR has received honoraria for scientific advice or lectures from Apopharma, Astrazeneca, Bial, Biogen, Britannia, Cerevel, Contera, GE Healthcare, Ionis, LGD Nuvamid, Lundbeck, Merz, Neuralight, Neuroderm, ONO Pharma, Orion Pharma, PD Neurotechnology, Roche Therapeutics, Sanofi, Servier, Sunovion, Supernus, Thelonius Mind, Takeda, Teva, UCB, Zambon and has received scientific grants from Agence Nationale de la Recherche (ANR), CHUde Toulouse, France-Parkinson, MJFox Foundation, French Ministry of Health (Programme Hospitalier de Recherche Clinique), European Commission (H2020 & Horizon Europe), CURE PARKINSON. WP reports personal fees AC Immune,BIAL, Lilly, Lundbeck, Neuroderm, Roche, Sanofi, Takeda, Teva, and Zambon for consultancy services in relation to clinical drug development programs for PD. AS is an employee of UCL and is Chief Investigator of ASProPD. He received grants from Cure Parkinson\u2019s, ASAP, MJFF, MRC (UK). He has consulted with Capsida and Neurocrine in the last 12\u00a0months. MT, EM, MC, KC, SA, NF, DD, FI, JM, TF, KK, OR, PW, WP and AHVS have nothing to disclose that relate to the research covered in the article. JD, RKW, HM and SRWS have no conflicts beyond being employees of Cure Parkinson\u2019s.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}}],"article-number":"151"}}