Ambroxol as a Novel Disease Modifying Treatment for Lewy Body Dementia

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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). Currently the main treatments for patients with LBD target symptom management. However, none of the medications treat the underlying cause of the disease, which includes the accumulation of protein in the brain. Therefore, even if patients respond well to symptomatic treatment, they continue to deteriorate. Therefore, the purpose of the current study is to make sure Ambroxol is safe to take long term and to test the effects of Ambroxol in treating the cognitive impairments associated with LBD by modifying the underlying causes of the disease.

There will be a total of 15 people participating this this study, which will last 52 weeks. Over the study period patients will undergo clinical, neuropsychological and neuroimaging assessment to assess changes.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ambroxol Hydrochloride
  • Placebo

Treatment groups

15 Participants
are divided into 2 treatment groups