Ambroxol for Parkinson's Disease Dementia

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests if Ambroxol, a safe over-the-counter medication, can help people with Parkinson's Disease Dementia by increasing an enzyme that reduces harmful proteins in the brain. The goal is to see if it improves memory and movement problems. Ambroxol has been shown to be safe and well tolerated in previous studies.

Eligibility Criteria

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.

Treatment Details

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.

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.