Ambroxol for Lewy Body Dementia

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

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

Trial Summary

What is the purpose of this trial?This trial tests if Ambroxol, a common mucus-clearing medicine, is safe and effective for treating Lewy Body Dementia (LBD). LBD patients are targeted because current treatments only manage symptoms and do not address the underlying protein buildup in the brain. Ambroxol increases an enzyme that helps break down these harmful proteins, potentially improving brain function.

Eligibility Criteria

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.

Inclusion Criteria

Montreal Cognitive Assessment (MoCA) score: 24-18

I am over 50 years old.

I have someone to take care of me for at least 4 days a week.

+1 more

Exclusion Criteria

I cannot have an MRI due to metal in my body or implanted devices.

I am not taking certain blood thinners but may use specific antiplatelet medications.

Depression that is, in the opinion of the investigator, significant enough to interfere with neuropsychology and safety assessments

+4 more

Participant Groups

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.

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.