Overview

Ambroxol as a Treatment for Parkinson's Disease Dementia

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lawson Health Research Institute
Collaborators:
London Health Sciences Centre
University of Western Ontario, Canada
Weston Brain Institute
Weston Foundation
Treatments:
Ambroxol
Criteria
Inclusion Criteria:

1. Age >50,

2. Mild to Moderate Dementia (established by an upper cut off of a Montreal Cognitive
Assessment score of 24 or below, and the lower bound by a Mini Mental State Exam of 16
or greater),

3. Parkinson's Disease (Hoehn & Yahr stage 2 - 3.5) clearly established more than 1 year
before the onset of dementia

4. Patients must have a responsible caregiver = 4 days/wk

5. Must be on stable doses of medications for Parkinson's disease mood and cognition
(Cholinesterase Inhibitor) for at least 3 months prior to the study.

Exclusion Criteria:

1. Evidence of clinically significant stroke or other neurological condition

2. Any other serious underlying condition (i.e. cancer or unstable cardiac disease etc.

3. Concurrent treatment with oral anticoagulants (including Vitamin K agonists and Novel
Oral Anticoagulants (NOACs)) within 4 weeks of screening or anticipated during the 52
week double-blind and open label periods. Specifically, Apixaban, Dabigatran,
Edoxaban, Fondaparinux, Rivaroxaban, and Warfarin are prohibited concomitant
medications.

3.1 Exceptions: antiplatelet agents such as Aspirin, Clopidogrel, and Aggrenox are allowed.