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Mucolytic Agent

Ambroxol for Parkinson's Disease Dementia

Phase 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 2, week 4, week 6, week 8, week 12, week 18, week 26, week 34, week 42, week 52

Awards & highlights

Study Summary

This trial will test whether the medication Ambroxol is safe and effective in improving cognitive and motor symptoms of Parkinson's Disease Dementia.

Who is the study for?

This trial is for individuals over 50 with Parkinson's Disease Dementia (PDD), who have mild to moderate dementia and a caregiver available at least 4 days a week. Participants must be on stable Parkinson's medication for three months, without serious conditions like significant strokes or cancer, and not on oral anticoagulants.Check my eligibility

What is being tested?

The study tests if Ambroxol can improve cognitive and motor symptoms in PDD by increasing beta-glucocerebrosidase levels, potentially lowering alpha-synuclein protein. This year-long trial involves clinical assessments, neuropsychological testing, and neuroimaging to monitor changes.See study design

What are the potential side effects?

While the side effects of Ambroxol in this context are being studied, it may include gastrointestinal discomforts such as nausea or diarrhea, headache, dizziness or allergic reactions. The severity of these side effects will be closely monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 2, week 4, week 6, week 8, week 12, week 18, week 26, week 34, week 42, week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 2, week 4, week 6, week 8, week 12, week 18, week 26, week 34, week 42, week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, week 4, week 6, week 8, week 12, 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

Changes in the ADCS-Clinician's Global Impression of Change (CGIC)

Changes in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)

Secondary outcome measures

Change in Quantitative Movement Testing

Changes in Cerebrospinal Fluid (CSF) biomarkers

Changes in GCAse in lymphocytes

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ambroxol high dose (1050 mg)Experimental Treatment1 Intervention

Participants randomized to the 1050 mg/day group will begin with a dose of 225mg (3 mg/kg/day), increasing bi-weekly by ~3mg/kg to a dose of 1050 mg/day (~l5 mg/kg/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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Western University, CanadaOTHER

239 Previous Clinical Trials

57,428 Total Patients Enrolled

London Health Sciences CentreOTHER

142 Previous Clinical Trials

49,863 Total Patients Enrolled

University of Western Ontario, CanadaOTHER

164 Previous Clinical Trials

319,191 Total Patients Enrolled

Media Library

Ambroxol (Mucolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02914366 — Phase 2

Parkinson's Disease Research Study Groups: Ambroxol high dose (1050 mg), Placebo

Parkinson's Disease Clinical Trial 2023: Ambroxol Highlights & Side Effects. Trial Name: NCT02914366 — Phase 2

Ambroxol (Mucolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02914366 — Phase 2

Frequently Asked Questions

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

How extensive is the participation in this clinical trial?

"At this juncture, the clinical trial is not presently seeking out patients for participation. The study was initially published on November 1st 2015 and most recently updated on August 29th 2022. For those looking to participate in other studies related to dementia, 861 trials are recruiting participants while 4 separate investigations require Ambroxol volunteers."

Answered by AI

Are there any official endorsements from the FDA regarding Ambroxol?

"Due to the Phase 2 nature of this trial, our team has deemed Ambroxol's safety a score of two. This is based on available data demonstrating its safety profile but lack any evidence for efficacy."

Answered by AI

Has Ambroxol been tested in earlier research studies?

"Presently, 4 trials are running to assess the efficacy of Ambroxol. Unfortunately, none of these tests have reached Phase 3 yet. Nevertheless, participants can be found in London Ontario and other surrounding areas."

Answered by AI

Is there still opportunity for patients to join this clinical experiment?

"This research has concluded its recruitment phase. First posted on November 1st 2015 and last edited August 29th 2022, no more candidates can join this study at present. For those searching for alternative trials, 861 studies recruiting patients with dementia are presently open as well as 4 different investigations into Ambroxol."

Answered by AI

Recent research and studies

Annals of NeurologyJournal

Glucocerebrosidase Deficiency in Substantia Nigra of Parkinson Disease Brains

Gegg, Matthew E., Derek Burke, Simon J. R. Heales, J. Mark Cooper, John Hardy, Nicholas W. Wood, and Anthony H. V. Schapira. 2012. “Glucocerebrosidase Deficiency in Substantia Nigra of Parkinson Disease Brains”. Annals of Neurology. Wiley. doi:10.1002/ana.23614.

Journal of Obstetrics and Gynaecology ResearchJournal

Antenatal Use of Ambroxol for the Prevention of Infant Respiratory Distress Syndrome

Laoag-Fernandez, Jovelle B., Alex M. Fernandez, and Takeshi Maruo. 2000. “Antenatal Use of Ambroxol for the Prevention of Infant Respiratory Distress Syndrome”. Journal of Obstetrics and Gynaecology Research. Wiley. doi:10.1111/j.1447-0756.2000.tb01327.x.

Journal of Perinatal MedicineJournal

An Alternative to Steroids for Prevention of Respiratory Distress Syndrome (RDS): Multicenter Controlled Study to Compare Ambroxol and Betamethasone

Luerti, Massimo, Adriano Lazzarin, Enzo Corbella, and Guido Zavattini. 1987. “An Alternative to Steroids for Prevention of Respiratory Distress Syndrome (RDS): Multicenter Controlled Study to Compare Ambroxol and Betamethasone”. Journal of Perinatal Medicine. Walter de Gruyter GmbH. doi:10.1515/jpme.1987.15.3.227.

The Lancet NeurologyJournal