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Device

Focused Ultrasound for Early Alzheimer's Disease (LIFUP-MCIAD Trial)

N/A

Recruiting

Led By Susan Y Bookheimer, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 50-90

Normal or corrected-to-normal hearing or vision

Must not have

Uncontrolled high blood pressure or diabetes

History of brain tumor, brain aneurysm, brain hemorrhage, or subdural hematoma (transient ischemic attack not exclusionary)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-lifup)

Summary

This trial is testing whether a new brain stimulation technique can improve memory in people with early Alzheimer's disease.

Who is the study for?

This trial is for English-speaking, right-handed individuals aged 50-90 with amnestic MCI who can consent and have normal or corrected vision/hearing. Excluded are those with MR-incompatible metal implants, certain genetic disorders, psychiatric conditions other than controlled anxiety/depression, severe organ diseases, recent cancer treatments to the head/neck area, autoimmune disorder treatments, substance abuse history (excluding nicotine/caffeine), significant head injuries or neurological disorders.

What is being tested?

The study tests if Low-Intensity Focused Ultrasound Pulsation (LIFUP) targeting the entorhinal cortex can activate brain regions connected to memory and improve memory function in a dose-dependent manner. It also examines how blood-based AD biomarkers and hippocampal volume changes relate to LIFUP outcomes.

What are the potential side effects?

Potential side effects of LIFUP may include discomfort at the site of application, headache during or after treatment, temporary hearing changes due to ultrasound noise exposure during treatment sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 90 years old.

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My hearing and vision are normal, or corrected to be normal.

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I have been diagnosed with amnestic mild cognitive impairment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My high blood pressure or diabetes is not under control.

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I have had a brain tumor, aneurysm, hemorrhage, or subdural hematoma.

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I am not currently receiving treatment for hepatitis, HIV, autoimmune disorders, or to prevent transplant rejection.

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I have had a severe head injury or concussion with significant symptoms or findings.

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I have 5 or more gold teeth that cannot be removed.

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I have been diagnosed with Cystic Fibrosis or Sickle Cell Disease.

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My cancer has spread to other parts of my body.

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I do not have severe heart, liver, lung, or kidney disease.

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I have received chemotherapy or radiation for head or neck cancer.

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I have had a stroke in the past.

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I have been diagnosed with a neurological disorder like Alzheimer's, Parkinson's, ALS, MS, or Cerebral Palsy.

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I weigh more than 275 pounds.

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I had a heart attack in the past year.

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I am taking medication to help with my memory or thinking.

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I take prescribed medication for migraines every day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Arteries

Brain

Secondary study objectives

Change in Brief Visual Memory Test Scores

Change in Verbal Learning Test Scores

Post-hoc biomarker analysis of APOE-4 status as a predictor of tFUS efficacy

+2 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: LIFUP Dose Group 3Active Control1 Intervention

Administration of low intensity focused ultrasound (LIFUP) dose level 3 to the entorhinal cortex.

Group II: LIFUP Dose Group 1Active Control1 Intervention

Administration of low intensity focused ultrasound (LIFUP) dose level 1 to the entorhinal cortex.

Group III: LIFUP Dose Group 2Active Control1 Intervention

Administration of low intensity focused ultrasound (LIFUP) dose level 2 to the entorhinal cortex.

Group IV: Sham LIFUPPlacebo Group1 Intervention

No administration of LIFUP. The device will be affixed to the user's head but not turned on. Additionally, if at the end of the study, the treatment has been shown to be effective, placebo subjects will be offered a free session using the optimally effective dose, if they consented to being contacted for this purpose.

0 / 18Eligibility criteria met