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
65+ years old, male or female
Amyloid positivity as assessed by either PET, CSF, or plasma.
Qualify for an MCI Diagnosis.
Study partner available for informant measures.
Early-onset Alzheimer's disease, as defined by a diagnosis occurring prior to age 65.
Clinically significant depression, as defined by a score of >10 on the Geriatric Depression Scale
Moderate to severe untreated obstructive sleep apnea, as defined by an Apnea-Hypopnea Index (AHI) ≥ 15.
Has other medical or psychiatric symptoms or conditions that, in the opinion of the investigator, will interfere with study activities or confound interpretation of study results.
Parallel
ATTN201 Focused Ultrasound to the CMN
DeviceLow-intensity focused ultrasound delivered to the centromedian nucleus of the thalamus by the investigational ATTN201 head-worn device.
ATTN201 Unfocused Ultrasound
DeviceUnfocused ultrasound delivered by the same device, serving as the control condition.
Incidence, Severity, and Relatedness of Adverse Events and Serious Adverse Events
Safety and tolerability of repeated ATTN201 stimulation, assessed by the incidence, severity, and relatedness of AEs and SAEs.
Incidence of New Clinically Significant Findings on Post-Treatment Safety MRI
Post-treatment brain MRI compared with the baseline MRI and reviewed for new clinically significant findings.
Study completion rate and adherence to scheduled study procedures
Proportion of randomized participants who complete all scheduled study procedures with acceptable adherence.
Change From Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB)
CDR-SB scores range from 0 to 18, with higher scores indicating greater cognitive and functional impairment.
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
ADAS-Cog scores range from 0-85 with higher scores indicating greater cognitive impairment.
Change From Baseline in the NULISASeq™ CNS Disease Panel 120
Blood samples will be collected using EDTA vials, minimally preprocessed, and stored for the duration of the study. Upon completion of the study, all samples will be analyzed using the NULISASeq™ CNS Disease Panel 120 for changes in Alzheimer's Disease biomarkers from baseline to post-treatment and follow-up.
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living for MCI (ADCS-MCI-ADL)
Scores range from 0 to 53, with higher scores indicating better daily function.
Change From Baseline in Functional Connectivity of the Centromedian Nucleus of the Thalamus
Resting-state fMRI-derived functional connectivity between the centromedian nucleus of the thalamus (CMN) and known brain networks.
Change From Baseline in Self-Reported Memory Complaints and Neurodegeneration-Related Psychiatric Symptoms
Measured by visual analog scales (range 1-100); higher scores indicate greater symptom burden.
Change From Baseline in NULISAseq Inflammation Panel 250
Samples will be collected via EDTA vials, minimally preprocessed, and stored for the duration of the study. Upon study completetion, samples will be analyzed for changes from baseline to post-treatment and follow-up in inflammatory biomarkers using the NULISAseq Inflammation Panel 250.
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University of California, San Francisco
Lead sponsor
Attune Neurosciences Inc
Collaborator
Gates Ventures
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
