NCT05773443

ANeED Joint Effort 21: eHealth and a PPI Program in Dementia With Lewybodies (DLB)

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
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Bergen · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Currently, there is no approved treatment for DLB patients, despite the increasing prevalence of DLB. As disease symptoms fluctuate between days and within-day inpatient clinic visits do not adequately capture the fluctuation in disease symptoms. Therefore there is a need for continuous registration. Additionally as DLB caregivers report a high level of caregiver distress, we extended the study to include caregivers to collect data on caregiver distress. For these reasons, a digital application was developed to report study medicine intake and side effects. Data collection from digital sensors (smartphone, smart watch, movement sensors, an EEG/EOG/ mood sensor and a bedside sleep monitor) register DLB symptoms continuously. To be eligible to participate in ANeED Joint Effort 21, patients and their caregivers need to be included in the ANeED study. There will be no additional inpatient clinic visits in ANeED Joint Effort 21, as measurements in between the visits are performed in-home. These measurements include cognitive tests on the smartphone and health data gathered by a smartwatch. Additionally, 2 wearable movement sensors will measure activity and sleep, a bedside sleep monitor that registers sleep disturbances, as well as an EEG-EOG-mood sensor for a duration of one week.

Conditions

• Dementia, Lewy Body

Interventions

Type	Name	Description
DEVICE	Digital biomarkers	Digital application Smartwatch Sleep monitor Movement sensor EEG-sensor

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-03-17
• Last updated: 2023-03-17

Locations

1 site across 1 country: Norway