drugset / Trial / NCT04588285
Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial
Phase 2
Recruiting
180 enrolled
Helse Fonna
Haraldsplass Deaconess Hospital · collabHelse Stavanger HF · collabHelse-Bergen HF · collabKlinbeforsk · collabOslo University Hospital · collabSt. Olavs Hospital · collabUniversity Hospital of North Norway · collabUniversity Hospital, Akershus · collab
RandomizedParallel-groupQuadruple-blindTreatment
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).
Timeline
- Start
- 2021-05-04
- Primary completion
- 2027-09-15
- Completion
- 2027-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ambroxol | Small molecule | 420 mg | Oral |