A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial to Demonstrate Clinical Efficacy on Cognitive, Neuropsychiatric and Functional Outcomes of Ambroxol in New and Early Patients With Prodromal and Mild Dementia With Lewybodies (ANeED) - Joint Effort 21: eHealth and a PPI-program in Dementia With Lewybodies (DLB)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

The goal of the study is to develop predictive algorithms and digital biomarkers to capture disease fluctuations in (prodromal) dementia with lewybodies (DLB) patients and to improve treatment, diagnosis and prognosis of the study drug Ambroxol, used in the ANeED study. This project is an additional study to the ANeED study, registered at ClinicalTrials.gov under NCT04588285.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:

‣ A patient is eligible when all inclusion criteria and none of the exclusion criteria are fullfilled in the ANeED study:

• 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

• Able and willing to provide informed consent prior to any study related assessments and procedures at screening visit 1.

• Capable of complying with all study procedures.

• Willing to provide blood samples for genetic analyses of APOE and GBA.

• 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)).

• Able to travel to the participating study site.

⁃ 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 \< 201 pmol/l at entry.

‣ Women of child-bearing potential must use accepted contraceptive methods (listed below), and must have a negative serum at screening visit 1 and urine pregnancy tests at subsequent visits if applicable. An additional pregnancy test will be performed, and results obtained, prior to administration of the first dose of ambroxol.

Locations
Other Locations
Norway
Helse Fonna
RECRUITING
Haugesund
Contact Information
Primary
Arvid Rongve, PhD
arvid.rongve@uib.no
90548749
Backup
Jessica Hubbers, MSc
jessica.hubbers@helse-fonna.no
91692898
Time Frame
Start Date: 2023-03
Estimated Completion Date: 2026-12
Participants
Target number of participants: 100
Treatments
Ambroxol: Digital biomarkers
Oral ambroxol medication, 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: Digital biomarkers
Oral placebo medication, 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)).
Caregivers
Primary family caregivers to participants
Sponsors
Collaborators: Helse Fonna, St. Olavs Hospital, Ullevaal University Hospital, Haraldsplass Deaconess Hospital, Helse Stavanger HF, University Hospital, Akershus
Leads: University of Bergen

This content was sourced from clinicaltrials.gov