NCT05032482

WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Scion NeuroStim · Industry
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a double- blind, randomized controlled trial with an open label extension designed to evaluate the safety and potential efficacy of a non-invasive brainstem neuromodulation device for treating symptoms associated with Alzheimer's disease (AD).

Detailed description

Up to 45 participants will first enter the double-blind, randomized controlled trial during which they will self-administer treatments twice daily in the home setting over 24 weeks with one of two investigational treatment modes. Participants who complete the randomized controlled trial will then enter the open label extension where all participants will self-administer twice-daily treatments over 24 weeks using the same investigational treatment mode that was reported to show benefit in a previous clinical trial in another neurodegenerative disease.

Conditions

• Mild Alzheimer's Disease

Interventions

Type	Name	Description
DEVICE	Non-invasive brainstem stimulation	Study participants will self-administer \~19-minute treatments twice daily in the home setting over 24 weeks using a non-invasive brainstem modulation device. All participants will use the same treatment mode during the open label extension.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2021-09-02
• Last updated: 2024-05-13

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study