CMN LIFU for Enhanced Glymphatic Clearance in Amyloid-Positive MCI
NCT ID
NCT07866768
Registry status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
University of California, San Francisco
Conditions
Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI), Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
Overview
ClinicalTrials.gov lists this study as Not yet recruiting.
Official title: 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
Enrollment: 28 participants (Estimated).
What is being studied
Device: ATTN201 Focused Ultrasound to the CMN
Device: ATTN201 Unfocused Ultrasound
Who may be eligible
Ages
65 Years to no maximum
Sex
All
Healthy volunteers accepted
No
ClinicalTrials.gov lists the following eligibility criteria.
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 consent in accordance with local regulations.
9. Be able to speak, read, and understand the language of the trial staff and the informed consent form.
10. Possess the ability to respond verbally to questions, follow instructions, and complete study assessments.
11. Be able to adhere to the stimulation protocol and visit schedules.
12. Be medically stable at baseline/randomization as assessed by medical history and non-significant clinical results of safety labs and vital signs examination.
Exclusion Criteria:
1. Early-onset Alzheimer's disease, as defined by a diagnosis occurring prior to age 65.
2. Clinically significant depression, as defined by a score of \>10 on the Geriatric Depression Scale
3. Moderate to severe untreated obstructive sleep apnea, as defined by an Apnea-Hypopnea Index (AHI) ≥ 15.
4. 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.
5. Is on medication which, in the opinion of the investigator, will confound study results.
6. Has a history of deep brain stimulation or ablative surgery
7. Has a history of substance abuse including alcohol use disorder in the past 6 months
8. Has a history of traumatic brain injury
9. Has any contraindications for completing a brain MRI scan.
a. The subject's head must fit within the head coil.
10. Has an uncontrolled medical condition which may impact study results.
11. Is or has an immediate family member of staff directly involved with this trial.
Study locations
1 study location is listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: United States
California, United States: 1
Sample of listed locations
University of California San Francisco — San Francisco, California, 94107, United States — Site recruitment status not specified in the registry data
Trial information can change. Confirm current study details with the study team or the registry.
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