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

Running, not enrolling · Early Phase 1

Conditions studied: Mild Cognitive Impairment, Alzheimer Disease 1

In brief

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).

Key facts

Study ID

NCT05469009

Run by

Ali Rezai

People needed

15

Starts

2022-07-14

Expected to finish

2029-07-01

Last updated by the study team

2026-01-22

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able and willing to give informed consent
• Probable mild cognitive impairment due to AD
• Modified Hachinski Ischemia Scale (MHIS) score of <= 4
• Mini Mental State Exam (MMSE) scores > 21+.
• Short form Geriatric Depression Scale (GDS) score of <= 7
• Amyloid PET scan consistent with the presence of β-amyloid (A+)
• Able to communicate sensations during the Exablate MRgFUS procedure
• Able to attend all study visits (i.e., life expectancy of 1 year or more)

You may not qualify if…

• MRI findings:
• Significant cardiac disease or unstable hemodynamic status
• History of a liver disease, bleeding disorder, coagulopathy or a history of spontaneous hemorrhage
• Known cerebral or systemic vasculopathy
• Significant depression (GDS > 7) and/or at potential risk of suicide (C-SSRS > 2)
• A severity score of 2 or more on any of the 'Delusions', 'Hallucinations' or 'Agitation/Aggression' subscales of the Neuropsychiatry Inventory (NPI-Q)
• Known sensitivity/allergy to gadolinium(gadobutrol), DEFINITY or its components, or 18F-florbetaben.
• Known hypersensitivity to DEFINITY or its components.
• Any contraindications to MRI scanning
• Untreated, uncontrolled sleep apnea
• History of untreated or uncontrolled seizure disorder or epilepsy.
• Impaired renal function
• Does not have a reliable caregiver
• 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.
• Respiratory: chronic pulmonary disorders
• History of clinically significant recent drug or alcohol use disorder who may be at higher risk for seizure or infection.
• Positive human immunodeficiency virus (HIV) which can lead to increased entry of HIV into the brain parenchyma leading to HIV encephalitis.
• Potential blood-borne infections, which can lead to increased entry to brain parenchyma leading to meningitis or brain abscess.

Where it is running

• West Virginia University Rockefeller Neuroscience Institute — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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