Actively Recruiting
Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial
Led by Helse Fonna · Updated on 2026-05-05
180
Participants Needed
8
Research Sites
332 weeks
Total Duration
On this page
Sponsors
H
Helse Fonna
Lead Sponsor
K
Klinbeforsk
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female.
- Age between 50 and 85 years.
- Confirmed diagnosis of Dementia with Lewy Bodies (DLB) or Mild Cognitive Impairment in DLB (DLB-MCI).
- Mini Mental Status Examination (MMSE) score of 15 or higher.
- Able and willing to give informed consent before any study assessments.
- Able to comply with all study procedures.
- Willing to provide blood samples for genetic analysis of APOE and GBA.
- Willing and able to self-administer or have a caregiver administer oral ambroxol medication as per dosing schedule.
- Able to travel to the study site.
- Female participants must be non-childbearing or use accepted contraceptive methods with negative pregnancy tests as required.
You will not qualify if you...
- Current treatment with anticoagulants that may prevent safe participation.
- Current or recent (within 30 days) participation in another investigational drug trial.
- Exposure to more than three investigational drugs within 12 months prior to this study.
- Confirmed swallowing difficulties preventing medication intake.
- Significant spinal abnormalities preventing lumbar puncture.
- Known allergy or sensitivity to ambroxol or its components.
- History of certain rare hereditary disorders affecting sugar metabolism.
- History of substance abuse or alcoholism affecting study participation.
- Blood donation within three months prior to first dose.
- Pregnant or breastfeeding, or unwilling to use birth control if applicable.
- Any unstable or significant psychiatric, medical, or surgical conditions that pose risk or affect study participation, including impaired kidney or liver function, recent major heart events, major depression, delirium, psychosis unrelated to DLB, metastatic cancer, or terminal illness.
- Planned major surgery or treatments during the study that interfere with participation.
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Helse Fonna
Haugesund, Haugesund, Norway, 5504
Actively Recruiting
2
Haraldsplass Deaconess Hospital
Bergen, Norway
Actively Recruiting
3
University Hospital, Akershus
Hågån, Norway
Actively Recruiting
4
University Hospital, Akershus
Lørenskog, Norway
Actively Recruiting
5
Oslo University Hospital
Oslo, Norway
Actively Recruiting
6
Stavanger University Hospital
Stavanger, Norway
Actively Recruiting
7
University Hospital North-Norway
Tromsø, Norway
Actively Recruiting
8
Trondheim University Hospital
Trondheim, Norway
Actively Recruiting
Research Team
A
Arvid Rongve, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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