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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
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Western University, CanadaOTHER
242 Previous Clinical Trials
57,452 Total Patients Enrolled
London Health Sciences CentreOTHER
143 Previous Clinical Trials
49,907 Total Patients Enrolled
University of Western Ontario, CanadaOTHER
164 Previous Clinical Trials
319,195 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Parkinson's Disease at stage 2 to 3.5, diagnosed over a year before any dementia.I have been on a steady dose of Parkinson's mood and cognition medication for 3 months.I am not taking any blood thinners like Warfarin or Rivaroxaban.I am taking Aspirin, Clopidogrel, or Aggrenox.I have had a stroke or another serious brain condition.I do not have any serious health conditions like unstable heart disease or another cancer.I am over 50 years old.You have mild to moderate memory and thinking problems, as measured by specific tests.I have a caregiver available for at least 4 days a week.
Research Study Groups:
This trial has the following groups:- Group 1: Ambroxol high dose (1050 mg)
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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