NCT04405596 · Phase 1 · NOT YET RECRUITING
Ambroxol as a Novel Disease Modifying Treatment for Lewy Body Dementia
This trial tests whether ambroxol, an existing drug, is safe and well tolerated over 52 weeks in people with Lewy body dementia. It also looks at whether it affects thinking problems by targeting protein buildup in the brain. Only 15 people take part. It is an early Phase 1 trial, focused mainly on safety, not yet proven to work or approved for this use.
You may qualify if
- 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
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2023-12-13