Dementia with Lewy Bodies (DLB) and mild cognitive impairment (MCI) due to Lewy Body Disease (DLB-MCI) MedDRA version: 20.0 Level: PT Classification code 10067889 Term: Dementia with Lewy bodies System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Mucosolvan
Product Name: Mucosolvan
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
Helse Fonna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female. 2. Age = 50 and = 85 years of age. 3. Confirmed diagnosis of Dementia with Lewybodies (DLB) including Mild Cognitive Impairment in DLB (DLB-MCI). 4. MMSE score>=15 5. Able and willing to provide informed consent prior to any study related assessments and procedures. 6. Capable of complying with all study procedures. 7. Willing to provide blood samples for genetic analyses of APOE and GBA 8. Willing and able to self-administer oral ambroxol medication, from day 1 to study end (at 60 mg TID (day 1-7), 120 mg TID (day 8- 14), 180 mg TID (day 15-21), 300 mg TID (day 22-28) and 420 mg TID (day 29-550)). 9. Able to travel to the participating study site. 10. A female participant is eligible to participate if she is of: ? Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 consecutive months of spontaneous amenorrhea, at least 6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) or post tubal ligation. In questionable cases, menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (FSH) 25.8 – 134.8 IU/L and oestradiol =65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: Participants are excluded from participating in this study if 1 or more of the following criteria are met: 1. Current treatment with anticoagulants (e.g. warfarin, argatroban, dabigatraneteksilat, rivaroksaban, apiksaban, edoksaban). 2. 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. 3. Exposure to more than three investigational medicinal products within 12 months prior to the first dose in the current study. 4. Confirmed dysphagia that would preclude self-administration of Ambroxol up to 7 tablets TID for the duration of this study. 5. 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. 6. History of known rare hereditary disorders of galactose Intolerance: Lapp lactase deficiency or glucose-galactose malabsorption. 7. History of illegal substance abuse, drug abuse or alcoholism in the opinion of the Investigator that would preclude participation in the study. 8. Donation of blood (one unit or 350 ml) within three months prior to receiving the first dose of the study drug. 9. Pregnant or breastfeeding. 10. All participants of child bearing potential in the opinion of the Investigator that would preclude participation in the study and who do not agree to use double-barrier birth control or abstinence while participating in the study and for 2 weeks following the last dose of the study drug. 11. Any clinically significant or unstable medical or surgical condition that in the opinion of the PI or PI-delegated clinician may put the participant at risk when participating in the study or may influence the results of the study or affect the participant’s ability to take part in the study, as determined by medical history, physical examinations, electrocardiogram (ECG), or laboratory tests. Such conditions may include: a) Impaired renal function b) Moderate/Severe hepatic impairment c) A major cardiovascular event (e.g. myocardial infarction, acute coronary syndrome, decompensated congestive heart failure, pulmonary embolism, coronary revascularisation that occurred within 6 months prior to the screening visit. d) Major stroke e) Major depression or psychotic disorder unrelated to DLB. f) Cancer or terminal illness. 12. Planned major surgical treatment during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate effect on a) cognitive- and b) neuropsychiatric symptoms and c) functional decline after 18 months treatment with ambroxol after 5 intra-participant dose escalations from 60 mg TID (day 1-7), 120 mg TID (day 8-14), 180 mg TID (day 15-21), 300 mg TID (day 22-28) and 420 mg TID (day 29 - 550);Secondary Objective: Evaluate the effect of ambroxol in DLB measured on questionnaires for evaluating sleep disturbances, falls, fluctuations and parkinsonism.;Primary end point(s): ?MMSE, and a cognitive test battery ?Clinician’s Global Impression of Change (ADCS-CGIC) ?CDR-SB ?NPI, GDS ;Timepoint(s) of evaluation of this end point: Endpoints will be calculated after 18 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Mayo Sleep Questionnaire (MSQ) ? Number of falls and falls related injury ? Mayo Fluctuations Scale ? Unified Parkinsons Disease Rating Scale -part III (motor part) ;Timepoint(s) of evaluation of this end point: Secondary endpoints will be calculated after 18 months and also after 30 months. | — |
Countries
Norway
Contacts
Public ContactDepartment of Research
Helse Fonna
Outcome results
None listed