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.
Parallel
Ambroxol
DrugOral ambroxol medication (60 mg) from day 1 to study end (at 60 mg TID (day 1-7), 120 mg TID (day 8- 14), 315 mg BID (day 15-21), 315 mg TID (day 22-28) and 420 mg TID (day 29-550)
Placebo
DrugOral placebo medication (60 mg) from day 1 to study end (at 60 mg TID (day 1-7), 120 mg TID (day 8- 14), 315 mg BID (day 15-21), 315 mg TID (day 22-28) and 420 mg TID (day 29-550)
Change in the incidence, nature and severity of AE's and SAE's from baseline.
Change in the number of participants with AE's and SAE's.
Change in the number of participants with treatment discontinuations and study discontinuation due to AEs from baseline.
Change from baseline in the number of participants with treatment and/or study discontinuation will be used to demonstrate safety and tolerability
Change in the number of participants with electrocardiogram (ECG) abnormalities.
Including QTc interval.
Change in blood analyses from baseline over time abnormalities.
Change from baseline in number of participants with abnormal changes in clinical laboratory blood tests from baseline over time for safety.
Mayo Sleep Questionnaire (MSQ).
To confirm the effect of The IMP Ambroxol in DLB measured on MSQ for evaluating sleep disturbances. MSQ is developed and validated in English version to detect Rapid Eye Movement - (REM) Sleep Behavior Disorder - (RBD) and several other sleep disorders in people with dementia and Parkinson's disease. RBD is part of the diagnosis of dementia with Lewy bodies. No score - only yes/no questions.
Mayo Fluctuation Scale (MFS)
To confirm the effect of The IMP Ambroxol in DLB measured on MFS for evaluating fluctuations. The Mayo Fluctuations Scale is a short questionnaire that evaluates cognitive fluctuation. Three or four points shows cognitive fluctuation. Scale 0-4.The higher the score the more disease progression
Unified Parkinson Disease Rating Scale (UPDRS-III)
To confirm the effect of The IMP Ambroxol in DLB measured on UPDRS-III for evaluating Parkinsonism. The unified Parkinson's disease rating scale (UPDRS) is used to follow the longitudinal course of Parkinson's disease. The UPD rating scale is the most commonly used scale in the clinical study of Parkinson's disease. Following the UPDRS scores over time provides insight into the patient's disease progression. Scale 0-138 points. The higher the score the more disease progression
Number of falls and related injury
To confirm the effect of The IMP Ambroxol in DLB measured on questions evaluating number of falls and related injury.
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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
