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

NCT04588285 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-05-05

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Ambroxol

Oral ambroxol medication (60 mg) from day 1 to study end (at 60 mg TID (day 1-7), 120 mg TID (day 8- 14), 315 mg BID (day 15-21), 315 mg TID (day 22-28) and 420 mg TID (day 29-550)

DRUG

Placebo

Oral placebo medication (60 mg) from day 1 to study end (at 60 mg TID (day 1-7), 120 mg TID (day 8- 14), 315 mg BID (day 15-21), 315 mg TID (day 22-28) and 420 mg TID (day 29-550)

Sponsors & Collaborators

  • Klinbeforsk

    collaborator OTHER

  • Helse-Bergen HF

    collaborator OTHER

  • Helse Stavanger HF

    collaborator OTHER_GOV

  • Oslo University Hospital

    collaborator OTHER

  • University Hospital, Akershus

    collaborator OTHER

  • Haraldsplass Deaconess Hospital

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • Helse Fonna

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-04
Primary Completion
2027-09-15
Completion
2027-09-15

Countries

  • Norway

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04588285 on ClinicalTrials.gov