Ultrasonic Debris Clearance for Dementia

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Ultrasonic Debris Clearance (UDC) to determine its safety for people at risk for Alzheimer's disease. UDC uses low-intensity ultrasound waves aimed at the brain to potentially clear harmful debris. The study tests whether this method can be safely used and if it shows benefits through specific health markers. Suitable candidates for this trial include those with amyloid deposits in the brain and mild memory issues or mild dementia. Participants will receive either the actual UDC treatment or a placebo over several sessions. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatments for Alzheimer's disease.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have received anti-amyloid monoclonal antibody therapy within the last 6 months, you would not be eligible to participate.

What prior data suggests that Ultrasonic Debris Clearance is safe for amyloid-positive adults?

Research has shown that Ultrasonic Debris Clearance (UDC) could effectively clear harmful debris from the brain. Before human testing, animal studies have demonstrated positive results. For instance, survival rates improved by 30% in animals after just a few short sessions of this noninvasive ultrasound treatment.

While UDC appears promising in these early studies, it is important to remember that this remains an initial study. Researchers are determining how well people tolerate the treatment and whether any side effects occur. This trial focuses on safety and practicality, and participants will provide valuable information on how this treatment works in humans.

Overall, the safety results in animal studies are encouraging, but human trials like this one are crucial to confirm these findings. Participants' experiences will help shape the future of this treatment for conditions like Alzheimer's disease.12345

Why are researchers excited about this trial?

Researchers are excited about Ultrasonic Debris Clearance (UDC) for dementia because it offers a new, non-invasive approach to potentially improve brain health. Unlike current dementia treatments, which often rely on medications to manage symptoms, UDC uses ultrasound waves to help clear debris and possibly improve cognitive function. This method stands out because it targets the physical accumulation of harmful proteins in the brain, which is a fundamental issue in dementia. By potentially enhancing the brain's natural cleaning process, UDC could offer benefits that current pharmaceutical treatments do not.

What evidence suggests that Ultrasonic Debris Clearance is effective for dementia?

Studies have shown that using ultrasound to clear waste from the brain can reduce swelling and improve recovery, particularly in conditions like hemorrhagic stroke. Research indicates that this noninvasive ultrasound process helps remove harmful waste, which can exacerbate brain diseases. Early tests on animals demonstrated a 30% increase in survival rates after just a few sessions. In this trial, participants will receive either the active Ultrasonic Debris Clearance (UDC) treatment or a sham version. Researchers are studying this treatment for its potential to help people at risk for Alzheimer's by strengthening the brain. Its promise lies in targeting and removing harmful substances from the brain, which could slow down or improve symptoms of memory and thinking problems.12345

Who Is on the Research Team?

RA

Raag Airan, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults aged 18 and older who have evidence of amyloid buildup in the brain, are at risk for Alzheimer's disease, or have mild cognitive impairment or mild dementia. Participants must be able to consent and complete study procedures.

Inclusion Criteria

1.1. Physician-reported amyloid positivity diagnosed by amyloid positron emission tomography (PET) OR historic CSF positivity of Abeta42, total tau, or phosphorylated tau OR positivity of plasma pTau-217.
I am able and willing to sign a consent form.
I am 18 years or older and, if female and under 60, I am not pregnant.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ultrasonic Debris Clearance (UDC) or sham intervention for multiple sessions across one month

1 month

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

What Are the Treatments Tested in This Trial?

Interventions

  • Ultrasonic Debris Clearance

Trial Overview

The study tests a noninvasive treatment called Ultrasonic Debris Clearance (UDC), which uses focused ultrasound on the scalp, compared to a sham (inactive) procedure. It aims to see if UDC is safe and practical for people with early signs of Alzheimer's.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention
Group II: ShamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Citations

Ultrasonic Debris Clearance to Promote Brain Resilience

This pilot study will evaluate the safety, tolerability, and feasibility of Ultrasonic Debris Clearance (UDC), a noninvasive low-intensity ...

Preclinical Research

“Impressively, survival improved by 30% after only three 10-minute applications using this noninvasive protocol. If these results translate to ...

Clearance of intracranial debris by ultrasound reduces ... - PMC

Impaired clearance of neurotoxic debris in the brain exacerbates neurologic disease and presents a promising therapeutic target.

Clearance of intracranial debris by ultrasound reduces ...

Impaired clearance of neurotoxic debris in the brain exacerbates neurologic disease and presents a promising therapeutic target.

Ultrasonic Debris Clearance for Dementia

This pilot study will evaluate the safety, tolerability, and feasibility of Ultrasonic Debris Clearance (UDC), a noninvasive low-intensity ...