Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial

Exclusion criteria

• . 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.
• . Significant known lower spinal malformations or other spinal abnormalities that would preclude lumbar puncture.
• . History of known sensitivity to the study medication, ambroxol or its excipients (lactose monohydrate, granulated microcrystalline cellulose, copovidone and magnesium stearate) in the opinion of the investigator that contraindicates their participation.
• . History of known rare hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
• . History of illegal substance abuse, drug abuse or alcoholism in the opinion of the Investigator that would preclude participation in the study.