Overview

Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for Mild Cognitive Impairment or Mild Alzheimer's Disease Undergoing Aduhelm Therapy.

Status:
Recruiting
Trial end date:
2029-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the safety and feasibility of administering standard of care monthly Aduhelm (Aducanumab) 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).
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ali Rezai
Collaborator:
InSightec
Criteria
Inclusion Criteria:

- 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

- IAmyloid 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)

Exclusion Criteria:

- 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 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.