Clinical Trial

Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial

Study acronym: ANeED
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This is a confirmatory investigational medicinal product (IMP) study to investigate the effects on cognition, functional decline and on neuropsychiatric symptoms of the Glucocerebrosidase (GCase) enhancing chaperone ambroxol in participants diagnosed with prodromal and early dementia with Lewybodies (DLB).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2020-10-08; most recent amendment 2026-04-29.
Status change: Not Yet Recruiting → Recruiting 2021-05-18
Trial Details
NCT Number NCT04588285
Lead Sponsor Helse Fonna
Collaborators: Klinbeforsk, Helse-Bergen HF, Helse Stavanger HF, Oslo University Hospital, University Hospital, Akershus, Haraldsplass Deaconess Hospital, St. Olavs Hospital, University Hospital of North Norway
Conditions Dementia With Lewy Bodies
Enrollment 180 participants
Start Date 2021-05-04
Primary Completion 2027-09-15 (estimated)
Study Completion 2027-09-15 (estimated)
Updated on ClinicalTrials.gov 2026-05-05