Study of Neuclare Device to Temporarily Improve Executive Function in Adults Aged 55 to 90 With Mild Cognitive Impairment or Early Alzheimers Disease Taking Medication

What this Trial Is About

Researchers are studying whether the Neuclare medical device can temporarily improve executive function, such as planning and problem-solving, in adults aged 55 to 90 years with mild cognitive impairment or early Alzheimers disease. This multicenter, randomized, double-blind, parallel-group trial evaluates the devices safety and efficacy alongside participants usual cognitive medications. The study is sponsored by Deepsonbio and aims to confirm the devices effect on cognitive abilities using established diagnostic criteria for these conditions. Participants continue their current cognitive therapy medications and are randomly assigned to one of two groups one receives the Neuclare device and the other a sham device that looks and feels similar but does not deliver therapeutic ultrasound. The device is applied to the brain three times per week for four weeks, with each session lasting less than 30 minutes. Both participants and study staff are unaware of group assignments to ensure unbiased results. During the trial, researchers will assess attention, cognitive function, activities of daily living, brain imaging using Amyloid PET-CT, blood biomarkers, and quality of life through questionnaires. Safety and adverse effects will be closely monitored throughout the study. The primary measurement is the change in completion time on the Trail Making Test-A from the start to week 5. Participant involvement lasts about five weeks, including treatment and assessments.

Neuclare Device for Temporary Improvement of Executive Function in Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease