RecruitingNCT05773443

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)

Sponsor

University of Bergen

Enrollment

100 participants

Start Date

Mar 1, 2023

Study Type

OBSERVATIONAL

Conditions

Dementia, Lewy Body

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

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Digital biomarkers for people with dementia, lewy body. The study is currently recruiting participants at 1 location. People eligible for this study include aged 50 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDigital biomarkers

Digital application Smartwatch Sleep monitor Movement sensor EEG-sensor

Locations(1)

Helse Fonna

Haugesund, Rogaland, Norway

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NCT05773443

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