Actively Recruiting
Clinical Trial to Evaluate Cognitive, Neuropsychiatric, and Functional Effects of Ambroxol in Early Dementia with Lewy Bodies
Led by Helse Fonna · Updated on 2026-05-05
180
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Helse Fonna
Lead Sponsor
K
Klinbeforsk
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of ambroxol, a drug that enhances Glucocerebrosidase (GCase), on cognition, functional decline, and neuropsychiatric symptoms in people diagnosed with prodromal and early dementia with Lewy bodies (DLB). This phase IIa study aims to confirm how ambroxol influences these areas compared to a placebo, with attention to disease progression and biomarkers related to DLB. Participants will be randomly assigned to take either oral ambroxol or a matching placebo. The medication dose escalates over the first month, starting at 60 mg three times daily and increasing to 420 mg three times daily, continuing up to 550 days. The study includes a blinded phase lasting 18 months, followed by an open extension offering ambroxol to all participants for an additional year. Throughout the study, participants will attend eight hospital visits and receive sixteen telephone calls to monitor safety, side effects, and treatment adherence. Various assessments will be conducted, including cognitive tests, neuropsychiatric evaluations, blood tests, MRI, DaTSCAN imaging, ECG, EEG, and lumbar punctures. The primary outcomes focus on cognitive changes, global function, disease stage, and neuropsychiatric symptoms, with secondary and exploratory outcomes addressing sleep, motor symptoms, falls, and biomarker impacts.
CONDITIONS
Brief 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 aged 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 study assessments
- Capable of following all study procedures
- Willing to provide blood samples for genetic testing of APOE and GBA
- Able to self-administer or receive ambroxol medication by caregiver as scheduled
- Able to travel to the study site
- Women must be non-childbearing or use approved contraception with negative pregnancy tests as required
You will not qualify if you...
- Current treatment with anticoagulants that may risk safety
- Participation in another clinical trial or investigational drug use within 30 days prior
- Exposure to more than three investigational drugs within 12 months prior
- Confirmed swallowing difficulties preventing medication intake
- Significant spinal problems preventing lumbar puncture
- Known allergy or sensitivity to ambroxol or its ingredients
- History of rare hereditary disorders affecting sugar metabolism
- Substance abuse or alcoholism that may interfere with participation
- Blood donation within three months before starting the study drug
- Pregnant or breastfeeding women or those unwilling to use birth control
- Any unstable or serious psychiatric, medical, or surgical condition that risks safety or study results
- Planned major surgery or treatments interfering with study participation
AI-Screening
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Your Study Journey
Duration - Up to 60 days before first dose
Participants are screened for eligibility to participate in the trial.
1 to 2 visits
Duration - 18 months
Participants take oral ambroxol or placebo with dose escalations over time while undergoing clinical and laboratory assessments to monitor safety and effects on cognitive and neuropsychiatric symptoms.
8 hospital visits and 16 telephone visits during the 18 months
Duration - 12 months
Participants are offered an additional 12 months of open-label ambroxol treatment following the blinded phase.
Visit schedule not specified
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
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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