Transcranial Focused Ultrasound for Dementia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neurological Associates of West Los Angeles

Disqualifiers: Major depressive disorder, advanced organ failure, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment that uses sound waves aimed at specific brain areas to help patients with memory and cognitive issues. The goal is to see if this method is safe and effective for people with mild cognitive impairment or dementia. The therapy has been shown to be effective and safe in animal models of Alzheimer's disease and vascular dementia, with previous trials indicating a tendency to suppress cognitive impairment.

Research Team

Sheldon E Jordan, M.D.

Principal Investigator

Neurology Management Associates

Eligibility Criteria

This trial is for people with mild cognitive impairment or early-stage dementia, evidenced by specific brain imaging markers. Participants must be able to give informed consent and lie still in a calm environment. Those with cognitive issues due to acute illness, scalp conditions, severe physical illnesses, major depression, or vascular dementia are excluded.

Inclusion Criteria

I have mild memory or thinking problems.

You have clear signs of a neurodegenerative condition in your brain scans.

Exclusion Criteria

I have been diagnosed with major depressive disorder.

I am unable to understand and give consent for treatment.

My cognitive issues are due to a recent illness.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial focused ultrasound treatment aimed at the hippocampus or the putamen and substantia nigra, depending on the condition. Treatment includes 8 sessions of focused ultrasound.

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using measures such as the Quick Dementia Rating Scale and Montreal Cognitive Assessment.

4 weeks

Treatment Details

Interventions

• Transcranial Focused Ultrasound

Trial Overview The study tests the safety and initial effectiveness of transcranial focused ultrasound as a treatment for neurodegenerative dementias like Alzheimer's and Parkinson's disease over an extended period.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

All patients enrolled will receive transcranial focused ultrasound. Target location is dependent on patient condition.

Who Is Running the Clinical Trial?

Neurological Associates of West Los Angeles

Lead Sponsor

Trials

26

Recruited

4,000+