This is a confirmatory investigational medicinal product (IMP) study to investigate the effects on cognition, functional decline and on neuropsychiatric symptoms of the Glucocerebrosidase (GCase) enhancing chaperone ambroxol in participants diagnosed with prodromal and early dementia with Lewybodies (DLB).
Male or female.
Age ≥ 50 and ≤ 85 years of age.
Confirmed diagnosis of Dementia with Lewy Bodies (DLB) or Mild Cognitive Impairment in DLB (DLB-MCI).
MMSE score>=15
Current treatment with anticoagulants (e.g. warfarin) that might preclude safe completion in the opinion of the Investigator.
Current use of investigational medicinal product or participation in another interventional clinical trial or who have done so within 30 days prior to the first dose in the current study.
Exposure to more than three investigational medicinal products within 12 months prior to the first dose in the current study;
Confirmed dysphagia that would preclude self-administration of ambroxol up to 6 tablets daily for the duration of day 1 to day 550/Month 18.
Helse Fonna
Lead sponsor
Klinbeforsk
Collaborator
Helse-Bergen HF
Collaborator
Helse Stavanger HF
Collaborator
Oslo University Hospital
Collaborator
University Hospital, Akershus
Collaborator
Haraldsplass Deaconess Hospital
Collaborator
St. Olavs Hospital
Collaborator
University Hospital of North Norway
Collaborator