Alzheimer's Disease study: ATTN201 Unfocused Ultrasound
Official title CMN LIFU for Enhanced Amyloid Reduction (CLEART Study)
ClinicalTrials.gov ID: NCT07866768
What this study is testing
- What it's testing
- This study checks if a wearable ultrasound device is safe and easy to use. It also looks to see if the device improves deep sleep and helps the brain clear away waste proteins.
- Who it's for
- Adults aged 65 and older who have mild memory problems and a buildup of amyloid protein in the brain.
- What's involved
- Participants will wear a device during 10 short naps over two weeks. They will also visit the clinic for brain scans, blood tests, and memory checks, and track their sleep at home.
- Time commitment
- The study lasts about two weeks for the main treatment, with a final visit and an optional check-up three months later.
- Time commitment: about 2 weeks
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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.
- Willing and able to undergo a brain MRI.
You likely can't join if
- 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...
- Is on medication which, in the opinion of the investigator, will confound study results.
- Has a history of deep brain stimulation or ablative surgery
See the full eligibility criteria
- 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.
- Willing and able to undergo a brain MRI.
- 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...
- Be able and willing to wear an Attune device during treatments
- Able to sign informed consent in accordance with local regulations.
- Be able to speak, read, and understand the language of the trial staff and the informed consent form.
- Possess the ability to respond verbally to questions, follow instructions, and complete study assessments.
- Be able to adhere to the stimulation protocol and visit schedules.
- Be medically stable at baseline/randomization as assessed by medical history and non-significant clinical results of safety labs and vital signs examination.
- 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.
- Is on medication which, in the opinion of the investigator, will confound study results.
- Has a history of deep brain stimulation or ablative surgery
- Has a history of substance abuse including alcohol use disorder in the past 6 months
- Has a history of traumatic brain injury
- Has any contraindications for completing a brain MRI scan. a. The subject's head must fit within the head coil.
- Has an uncontrolled medical condition which may impact study results.
- Is or has an immediate family member of staff directly involved with this trial.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.