Study of Cerogrin Device for Ear Nerve Stimulation to Improve Thinking in People Aged 55 to 89 With Vascular Dementia or Mild Cognitive Impairment

What this Trial Is About

Researchers are evaluating the preliminary effectiveness and safety of Cerogrin, a medical device designed for auricular vagus nerve stimulation, in patients with vascular dementia or vascular mild cognitive impairment. This study addresses the limited availability of effective drug treatments for these conditions by assessing whether non-invasive stimulation can improve cognitive function. It is a randomized, double-blind feasibility trial conducted by Neurogrin Inc. to explore a potential new therapeutic option. Participants will be randomly assigned to two groups one will use the active Cerogrin device that delivers electrical stimulation to the vagus nerve on the outer ear, while the other will use a sham device that looks identical but provides no stimulation. Each participant will use their assigned device daily at home for 30 minutes over a four-week intervention period. The study includes baseline assessments, the intervention period, and follow-up monitoring, lasting up to three months in total. During the study, participants will undergo evaluations of cognitive function using various tests such as the Clinical Dementia Rating, Korean Montreal Cognitive Assessment, and Alzheimers Disease Assessment Scale. Brain imaging with MRI and functional assessments with EEG will also be performed to monitor neural activity. Safety and adherence will be closely observed throughout the study, with outcome measurements taken at baseline, after the four-week intervention, and at follow-up up to eight weeks post-intervention.

Evaluation of Cerogrin for Auricular Vagus Nerve Stimulation in Vascular Dementia or Vascular Mild Cognitive Impairment