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CMN LIFU for Enhanced Glymphatic Clearance in Amyloid-Positive MCI

Safety and Feasibility Study of ATTN201 Centromedian Nucleus of the Thalamus Focused Ultrasound Stimulation for Enhanced Glymphatic Clearance in Amyloid Positive Patients With Mild Cognitive Impairment

Sponsor
University of California, San Francisco (Academic or other)
Enrolment
28 planned
Conditions
Alzheimer's Disease (AD); Mild Cognitive Impairment (MCI); Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
Interventions
ATTN201 Focused Ultrasound to the CMN; ATTN201 Unfocused Ultrasound
Ages
older adults
Registry
NCT07866768

Full record on ClinicalTrials.gov

From the registry

The goal of this clinical trial is to learn if a wearable ultrasound device, called ATTN201, is safe and easy to use. The study is for adults ages 65 and older who have mild cognitive impairment (MCI) and a buildup of a protein called amyloid in the brain. Amyloid buildup is an early sign of Alzheimer's disease. The ATTN201 device sends low-intensity sound waves to a deep area of the brain that helps control sleep. The aim is to boost deep-sleep brain waves. These brain waves may help the brain clear away waste, including amyloid. The main questions it aims to answer are: 1. What, if any, issues do participants have when using the ATTN201 device? 2. Can participants complete the full study schedule? Researchers will compare focused ultrasound to unfocused ultrasound. Unfocused ultrasound is a look-alike treatment. It feels and sounds the same but is not aimed at the brain target. The comparison will show if the focused treatment changes sleep brain waves, blood markers of Alzheimer's disease, or memory and thinking. Participants will: * Visit the study site for memory and…

Primary outcomes

  • Incidence, Severity, and Relatedness of Adverse Events and Serious Adverse Events
  • Incidence of New Clinically Significant Findings on Post-Treatment Safety MRI
  • Study completion rate and adherence to scheduled study procedures

History

  1. Primary completion expected

  2. Started

  3. Last registry update

  4. Registered