ACTIVE_NOT_RECRUITING

Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for Mild Cognitive Impairment or Mild Alzheimer's Disease Undergoing Standard of Care Monoclonal Antibody (mAb) Therapy

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Conditions

Mild Cognitive ImpairmentAlzheimer Disease 1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the safety and feasibility of administering standard of care monoclonal antibody (mAb) infusion therapy in combination with opening the blood-brain barrier with the Exablate Model 4000 Type 2 device in patients with mild Alzheimer's disease (AD) or mild cognitive impairment (MCI).

Official Title

Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for the Treatment of Patients With With Mild Cognitive Impairment (MCI) or Mild Alzheimer's Disease (AD) Undergoing Standard of Care Monoclonal Antibody (mAb) Therapy

Quick Facts

Study Start:2022-07-14
Study Completion:2029-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05469009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able and willing to give informed consent
  2. * Probable mild cognitive impairment due to AD
  3. * Modified Hachinski Ischemia Scale (MHIS) score of \<= 4
  4. * Mini Mental State Exam (MMSE) scores \> 21+.
  5. * Short form Geriatric Depression Scale (GDS) score of \<= 7
  6. * Amyloid PET scan consistent with the presence of β-amyloid (A+)
  7. * Able to communicate sensations during the Exablate MRgFUS procedure
  8. * Able to attend all study visits (i.e., life expectancy of 1 year or more)
  1. * MRI findings:
  2. * Significant cardiac disease or unstable hemodynamic status
  3. * History of a liver disease, bleeding disorder, coagulopathy or a history of spontaneous hemorrhage
  4. * Known cerebral or systemic vasculopathy
  5. * Significant depression (GDS \> 7) and/or at potential risk of suicide (C-SSRS \> 2)
  6. * A severity score of 2 or more on any of the 'Delusions', 'Hallucinations' or 'Agitation/Aggression' subscales of the Neuropsychiatry Inventory (NPI-Q)
  7. * Known sensitivity/allergy to gadolinium(gadobutrol), DEFINITY or its components, or 18F-florbetaben.
  8. * Known hypersensitivity to DEFINITY or its components.
  9. * Any contraindications to MRI scanning
  10. * Untreated, uncontrolled sleep apnea
  11. * History of untreated or uncontrolled seizure disorder or epilepsy.
  12. * Impaired renal function
  13. * Does not have a reliable caregiver
  14. * Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research.
  15. * Respiratory: chronic pulmonary disorders
  16. * History of clinically significant recent drug or alcohol use disorder who may be at higher risk for seizure or infection.
  17. * Positive human immunodeficiency virus (HIV) which can lead to increased entry of HIV into the brain parenchyma leading to HIV encephalitis.
  18. * Potential blood-borne infections, which can lead to increased entry to brain parenchyma leading to meningitis or brain abscess.

Contacts and Locations

Principal Investigator

Ali Rezai, MD, FAANS
PRINCIPAL_INVESTIGATOR
WVU Rockerfeller Neuroscience Institute

Study Locations (Sites)

West Virginia University Rockefeller Neuroscience Institute
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: Ali Rezai

  • Ali Rezai, MD, FAANS, PRINCIPAL_INVESTIGATOR, WVU Rockerfeller Neuroscience Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-14
Study Completion Date2029-07

Study Record Updates

Study Start Date2022-07-14
Study Completion Date2029-07

Terms related to this study

Additional Relevant MeSH Terms

  • Mild Cognitive Impairment
  • Alzheimer Disease 1