Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind
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).
| Condition(s) | Dementia With Lewy Bodies |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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). |
| Who can participate | Inclusion Criteria: 1. Male or female. 2. Age ≥ 50 and ≤ 85 years of age. 3. Confirmed diagnosis of Dementia with Lewy Bodies (DLB) or 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 at screening visit 1. 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 or administer by a caregiver oral ambroxol medication, from day 1 to study end (at 60 mg TID (day 1-7), 120 mg TID (day 8- 14), 315 BID (day 15-21), 315 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 |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Lead sponsor | Helse Fonna |
| Locations | Haugesund, Haugesund, Norway; Bergen, Norway; Hågån, Norway; Lørenskog, Norway; Oslo, Norway; Stavanger, Norway (+2 more sites) |
| Start date | 2021-05-04 |
| NCT ID | NCT04588285 |
| Official listing | https://clinicaltrials.gov/study/NCT04588285 |