NCT05469009Active, not recruitingEarly phase 1

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

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

Source: ClinicalTrials.gov · Last updated 22 Jan 2026

Brief summary (registry, in English)

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).

Status (registry): Active, not recruiting
Phase (registry): Early phase 1
Study type: Interventional
Enrollment: 15 (estimated)
First submitted: 19 Jul 2022
Start date: 14 Jul 2022
Primary completion date: Jul 2029
Lead sponsor: Ali Rezai
Diseases: Alzheimer disease
NCT number: NCT05469009

What you commit to

Study type: Interventional · Early phase 1
Planned participants: 15
From 14 Jul 2022 to the primary completion date, Jul 2029
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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.

Other illness

Significant cardiac disease or unstable hemodynamic status
History of a liver disease, bleeding disorder, coagulopathy or a history of spontaneous hemorrhage
Known sensitivity/allergy to gadolinium(gadobutrol), DEFINITY or its components, or 18F-florbetaben.
Known hypersensitivity to DEFINITY or its components.
History of untreated or uncontrolled seizure disorder or epilepsy.
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.

Other

MRI findings:
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)
Any contraindications to MRI scanning
Untreated, uncontrolled sleep apnea
Impaired renal function
Does not have a reliable caregiver

Who the study is looking for

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)

Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
West Virginia University Rockefeller Neuroscience Institute Coordinator of this site? Confirm its status	Morgantown	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.