💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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