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
University of California, San Francisco
Summary
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 thinking tests, blood draws, a health check, and MRI scans of the brain * Record their sleep at home for at least 5 days with a sleep diary, a watch-like sensor, and a headband that measures brain waves * Be assigned by chance to focused or unfocused ultrasound * Take part in 10 nap sessions over 2 weeks while wearing the device, at the study site or at home * Return for a final visit to repeat the first tests, and may return for an optional visit 3 months later
Description
This pilot study is a randomized, double-blind, parallel-group trial of repeated low-intensity focused ultrasound (LIFU) stimulation of the centromedian nucleus of the thalamus (CMN) in amyloid-positive older adults with mild cognitive impairment (MCI). Background and rationale: Poor sleep both predicts and accelerates Alzheimer's disease (AD) pathology, in part by impairing glymphatic clearance of metabolites including soluble amyloid-beta and tau. Slow waves during sleep generate metabolic signals that alter neurovascular tone and cerebrospinal fluid (CSF) volume, creating pulsatile fluid f…
Eligibility
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 65+ years old, male or female 2. Amyloid positivity as assessed by either PET, CSF, or plasma. 3. Qualify for an MCI Diagnosis. 4. Study partner available for informant measures. 5. Willing and able to undergo a brain MRI. 6. If currently on AD or sleep medications, must be at the same stable dose(s) for at least 3 weeks prior to screening and throughout the course of the study, and must continue to be under the care of their treating neurologist through the duration of the study. 7. Be able and willing to wear an Attune device during treatments 8. Able to sign informed…
Interventions
- DeviceATTN201 Focused Ultrasound to the CMN
Low-intensity focused ultrasound delivered to the centromedian nucleus of the thalamus by the investigational ATTN201 head-worn device.
- DeviceATTN201 Unfocused Ultrasound
Unfocused ultrasound delivered by the same device, serving as the control condition.
Location
- University of California San FranciscoSan Francisco, California