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Mucolytic Agent

Ambroxol for Lewy Body Dementia

Phase 1 & 2

Waitlist Available

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than 50 years old

Must be on a stable dose of medications for parkinsonism (levodopa, dopaminergic agonist) and cognition (cholinesterase inhibitors) and psychiatric (i.e. antidepressants, antipsychotic) for at least 3 months prior to the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4, week 10, week 18, week 26, week 34, week 42, week 52

Awards & highlights

Study Summary

This trial is testing whether a medication called Ambroxol is safe and effective for treating Lewy Body Dementia by modifying the underlying causes of the disease. There will be 15 people participating in the study, which will last 52 weeks.

Who is the study for?

This trial is for people over 50 with Lewy Body Dementia, who have a caregiver at least 4 days a week and are on stable medication for parkinsonism, cognition, and psychiatric symptoms. Pregnant women or those planning to conceive during the study can't participate. People with metal in their body that affects MRI scans or taking certain blood thinners also can't join.Check my eligibility

What is being tested?

The study tests Ambroxol Hydrochloride's safety and effectiveness against Lewy Body Dementia compared to a placebo. It's randomized (participants are randomly assigned treatment), double-blind (neither researchers nor participants know who gets what), lasting one year with assessments throughout.See study design

What are the potential side effects?

While specific side effects of Ambroxol in this context aren't detailed here, common ones may include allergic reactions, gastrointestinal discomforts like nausea or vomiting, headache, dizziness, dry mouth/throat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 50 years old.

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I have been on a stable dose of my Parkinson's and mental health medications for at least 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4, week 10, week 18, week 26, week 34, week 42, week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 4, week 10, week 18, week 26, week 34, week 42, week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, week 10, week 18, week 26, week 34, week 42, week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in cerebrospinal fluid (CSF) concentrations of Ambroxol at specified time points

Change from baseline in enzyme β-Glucocerebrosidase (GCase) concentration levels in CSF

Change from baseline in enzyme β-Glucocerebrosidase (GCase) concentration levels in white blood cells

+9 more

Secondary outcome measures

Change in Cerebrospinal Fluid (CSF) biomarkers

Change in global brain magnetic resonance imaging atrophy measures

Change in plasma biomarkers

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AmbroxolExperimental Treatment1 Intervention

Participants randomized to the 1350 mg/day group will begin with a dose of 450 mg, increasing bi-weekly to a dose of 1350 mg/day.

Group II: PlaceboPlacebo Group1 Intervention

Participants receive capsules visually identical to the experimental groups but without active ingredients.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ambroxol

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

656 Previous Clinical Trials

413,413 Total Patients Enrolled

1 Trials studying Lewy Body Disease

1,000 Patients Enrolled for Lewy Body Disease

Media Library

Ambroxol Hydrochloride (Mucolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04405596 — Phase 1 & 2

Lewy Body Disease Research Study Groups: Ambroxol, Placebo

Lewy Body Disease Clinical Trial 2023: Ambroxol Hydrochloride Highlights & Side Effects. Trial Name: NCT04405596 — Phase 1 & 2

Ambroxol Hydrochloride (Mucolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04405596 — Phase 1 & 2

Lewy Body Disease Patient Testimony for trial: Trial Name: NCT04405596 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently recruiting participants?

"Unfortunately, this trial is currently closed to new enrolment. It was initially made available on November 1st 2023, and last edited August 29th 2022. However, 401 trials related to Lewy Body Disease are still active as well 4 Ambroxol Hydrochloride studies searching for participants."

Answered by AI

What objectives does this research endeavor seek to fulfill?

"This clinical trial is designed to analyse the prevalence, characterisation, and intensity of adverse effects (AEs) and serious adverse events (SAEs). The primary endpoints include evaluating cognitive decline using Montreal Cognitive Assessment (MoCA), Repeatable Battery for the Assessment of Neuropsychological Status, as well as Clinician's Global Impression of Change. These measures are conducted over various intervals spanning through a year: Baseline, week 4, 10 18, 26 34 42 52."

Answered by AI

How many patients have been enlisted for involvement in this medical study?

"Unfortunately, applications for this trial are no longer being accepted. It was first advertised on November 1st 2023 and its last update was August 29th 2022. However, there are 401 studies recruiting individuals with Lewy Body Disease in addition to 4 trials seeking Ambroxol Hydrochloride volunteers."

Answered by AI