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Ambroxol as a Treatment for Parkinson's Disease Dementia

NCT02914366 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-02-28

No results posted yet for this study

Summary

The present study will test the hypothesis that the medication Ambroxol is safe and well tolerated and will improve cognitive and motor symptoms of Parkinson's Disease Dementia (PDD). Ambroxol has been shown to raise the levels of the enzyme beta-glucocerebrosidase resulting in lower the levels of the protein alpha-synuclein, both of which have been shown to improve cognition in mouse models. This will be a 52 week trial of Ambroxol in 75 individuals with PDD. Participants will undergo clinical, neuropsychological and neuroimaging assessment throughout the study to assess changes.

Conditions

  • Parkinson's Disease Dementia

Interventions

DRUG

Ambroxol

OTHER

Placebo

Sponsors & Collaborators

  • Weston Brain Institute

    collaborator OTHER

  • Western University, Canada

    collaborator OTHER

  • London Health Sciences Centre

    collaborator OTHER

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02914366 on ClinicalTrials.gov