Status:
NOT_YET_RECRUITING
Ambroxol as a Novel Disease Modifying Treatment for Lewy Body Dementia
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Lewy Body Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a randomized, placebo-controlled, double-blind study investigating whether the medication Ambroxol is safe,effectiveness and well tolerated for the treatment of Lewy Body Dementia (LBD). Curre...
Detailed Description
The increasing prevalence of dementia is a serious threat to our medical system and our society. About 500,000 Canadians are affected with dementia, and this number will rise to more than 1 million in...
Eligibility Criteria
Inclusion
- Probable diagnosis of Lewy Body Dementia
- Age greater than 50 years old
- Montreal Cognitive Assessment (MoCA) score: 24-18
- Patients must have a responsible caregiver = 4days/week
- Must be on a stable dose of medications for parkinsonism (levodopa, dopaminergic agonist) and cognition (cholinesterase inhibitors) and psychiatric (i.e. antidepressants, antipsychotic) for at least 3 months prior to the study
Exclusion
- Evidence of stroke or other neurological condition
- Any other serious underlying condition or brain disorder that can account in part of in full for the clinical presentation (i.e. cancer or unstable cardiac disease etc.)
- Contraindication to MRI e.g. presence of metal fragments in head or eye, implanted electrical devices or conductive implants or devices (pacemakers, neurostimulators).
- Unable to undergo DAT-scan
- Depression that is, in the opinion of the investigator, significant enough to interfere with neuropsychology and safety assessments
- Females who are pregnant or breastfeeding, or planning to conceive within the study period
- 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. Exceptions: antiplatelet agents such as Aspirin, Clopidogrel, and Aggrenox.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04405596
Start Date
January 1 2025
End Date
January 1 2027
Last Update
December 13 2023
Active Locations (1)
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1
Parkwood Institute
London, Ontario, Canada, N6C0A7