ANeED Joint Effort 21: eHealth and a PPI Program in Dementia With Lewybodies (DLB)
ConditionDementia, Lewy Body
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-85
SponsorUniversity of Bergen
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial population
Participants already included in ANeED drug trial with willingness to comply to the additional study.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Digital biomarkers
DeviceDigital application Smartwatch Sleep monitor Movement sensor EEG-sensor
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Ambroxol: Digital biomarkers1 intervention
Group B: Placebo: Digital biomarkers1 intervention
Group C: Caregivers1 intervention
Trial outcomes
Primary outcomes
1
Digital biomarkers for diagnostic support and medication efficacy
Time frame
All patient visits from start to 18 months (end of treatment).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Bergen
Lead sponsor
Helse Fonna
Collaborator
Helse Stavanger HF
Collaborator
University Hospital, Akershus
Collaborator
Ullevaal University Hospital
Collaborator
Haraldsplass Deaconess Hospital
Collaborator
St. Olavs Hospital
Collaborator
Source ClinicalTrials.gov