Overview
Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for Mild Cognitive Impairment or Mild Alzheimer's Disease Undergoing Aduhelm Therapy.
Status:
Recruiting
Recruiting
Trial end date:
2029-07-01
2029-07-01
Target enrollment:
0
0
Participant gender:
All
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 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Ali RezaiCollaborator:
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.