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Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

Primary Purpose

Alzheimer Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
low intensity focused ultrasound (LIFU)
Sponsored by
Ali Rezai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males and non-pregnant females, aged 45-85 years Able and willing to give informed consent Must meet the clinical criteria for MCI due to Alzheimer's disease If receiving concurrent treatment with an AChEI and/or memantine, has been on a stable dose for at least 45 days Able to communicate sensations during the LIFU procedure Exclusion Criteria: Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia). Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain. Participants with a history of seizure disorder. Participants with clinically significant chronic pulmonary disorders e.g., severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area. Participant does not speak English Participant is pregnant or planning to be pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Neuromodulation

    Arm Description

    Subjects meeting eligibility criteria will undergo Exablate low intensity focused ultrasound neuromodulation

    Outcomes

    Primary Outcome Measures

    Occurrence of Treatment Emergent Adverse Events
    Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.
    Cognitive Change
    Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

    Secondary Outcome Measures

    Imaging Changes
    Changes in brain metabolism and connectivity using PET and fMRI

    Full Information

    First Posted
    August 4, 2023
    Last Updated
    August 10, 2023
    Sponsor
    Ali Rezai
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05997030
    Brief Title
    Low-Intensity Focused Ultrasound (LIFU) Neuromodulation
    Official Title
    Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2025 (Anticipated)
    Study Completion Date
    September 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ali Rezai

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with mild cognitive impairment ( MCI) due to Alzheimer's disease.
    Detailed Description
    The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for MCI due to AD

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Neuromodulation
    Arm Type
    Experimental
    Arm Description
    Subjects meeting eligibility criteria will undergo Exablate low intensity focused ultrasound neuromodulation
    Intervention Type
    Device
    Intervention Name(s)
    low intensity focused ultrasound (LIFU)
    Intervention Description
    Subjects will undergo undergo a single LIFU of the target brain region
    Primary Outcome Measure Information:
    Title
    Occurrence of Treatment Emergent Adverse Events
    Description
    Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.
    Time Frame
    baseline and 7 and days after study procedure
    Title
    Cognitive Change
    Description
    Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
    Time Frame
    baseline and 7 days after procedure
    Secondary Outcome Measure Information:
    Title
    Imaging Changes
    Description
    Changes in brain metabolism and connectivity using PET and fMRI
    Time Frame
    baseline, 7 and 30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males and non-pregnant females, aged 45-85 years Able and willing to give informed consent Must meet the clinical criteria for MCI due to Alzheimer's disease If receiving concurrent treatment with an AChEI and/or memantine, has been on a stable dose for at least 45 days Able to communicate sensations during the LIFU procedure Exclusion Criteria: Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia). Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain. Participants with a history of seizure disorder. Participants with clinically significant chronic pulmonary disorders e.g., severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area. Participant does not speak English Participant is pregnant or planning to be pregnant
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marc Haut, PhD
    Phone
    3042934816
    Email
    mhaut@hsc.wvu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kiley Everson
    Phone
    3042931316
    Email
    kiley.everson@hsc.wvu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ali Rezai
    Organizational Affiliation
    WVU Rockefeller Neuroscience Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

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