Phase IIa Study of Ambroxol to Improve Cognitive and Functional Outcomes in Early Dementia With Lewy Bodies Using eHealth Tools and a Caregiver Support Program

What this Trial Is About

Researchers are studying dementia with Lewy bodies DLB, focusing on developing digital tools to monitor disease symptoms that can vary daily and even within a day. The study aims to improve diagnosis, treatment, and prognosis by capturing these fluctuations using digital biomarkers. It is an observational extension of the ANeED study, which evaluates the use of the study drug Ambroxol in patients with early or mild DLB. Participants include patients taking oral Ambroxol or a placebo with gradually increasing doses from day 1 through day 550, along with their primary caregivers. The study uses a digital application, smartwatches, sleep monitors, movement sensors, and EEGEOGmood sensors to continuously collect health data and monitor symptoms remotely at home. Caregivers also report their distress levels as part of the study. Participants will complete cognitive tests on a smartphone and wear various sensors for one week to record activity, sleep, and mood. Data on medication intake and side effects are logged via the digital app. The main outcome measured is the use of digital biomarkers to support diagnosis and assess medication effects over an 18-month treatment period. There are no additional clinic visits beyond those in the original ANeED study, and all monitoring is done in the participants home environment.

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