Low Intensity Focused Ultrasound for Mild Cognitive Impairment and Mild Alzheimer's Disease

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT05417555
Status
Recruiting
Apply to this trial

Conditions

  • Amnestic Mild Cognitive Disorder
  • Deep Brain Stimulation
  • Mild Alzheimer's Disease
  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Low-Intensity Focused Ultrasound Pulsation (LIFUP) — DEVICE
    Low intensity focused ultrasound pulsation will be administered to the left entorhinal cortex at 650kHz, ispta.3 720mW/cm, pulse repetition frequency 100Hz, duty cycle 50%, duration 30s with 30s spacing between sonications, 6 sonications per dose (participants receive 0, 1, 2 or 3 doses depending on group assignment)

Study Details

The goal of this study is to investigate whether Low Intensity Focused Ultrasound Pulsation (LIFUP) targeting a part of the brain involved in memory will have an affect on brain activity and whether it may improve memory in people with Mild Cognitive Impairment and Mild Alzheimer's Disease. The main questions the study seeks to answer are: 1. Can LIFUP increase brain activity in the targeted area? 2. Can LIFUP improve memory in people with MCI and mild AD? 3. Can LIFUP improve connectivity of memory networks in the brain? Participants in this study will complete MRIs and memory testing, and receive Low Intensity Focused Ultrasound to a part of their brain involved in memory (the entorhinal cortex).

Key Dates

Start date
Sep 1, 2022
Status verified
Dec 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: LIFUP Dose Group 1
    Administration of low intensity focused ultrasound (LIFUP) dose level 1 to the entorhinal cortex.
  • Active Comparator: LIFUP Dose Group 2
    Administration of low intensity focused ultrasound (LIFUP) dose level 2 to the entorhinal cortex.
  • Active Comparator: LIFUP Dose Group 3
    Administration of low intensity focused ultrasound (LIFUP) dose level 3 to the entorhinal cortex.
  • Sham Comparator: Sham LIFUP
    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.

Primary Outcome Measure

Change in Perfusion Arterial Spin Labeling (ASL) fMRI Signal throughout Brain [ Time Frame: 40 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA Semel Institute for Neuroscience and BehaviorLos AngelesCalifornia90024
Natalie Rotstein
[email protected]
3107940077
Sabrina Halavi
[email protected]
3107940077
Susan Y Bookheimer, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
UCLA Semel Institute for Neuroscience and Behavior· Los Angeles, CA

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