Clinical trial
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
Name
2110449196
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).
Trial arms
Trial start
2022-07-14
Estimated PCD
2029-07-01
Trial end
2029-07-01
Status
Recruiting
Phase
Early phase I
Treatment
Aducanumab
Standard aducanumab therapy will be given by intravenous infusion every 4 weeks for 6 cycles with blood brain barrier opening
Arms:
Infusion plus Exablate BBBO Treatment
Other names:
Aduhelm
Exablate Model 4000 Type 2
The Exablate Model 4000 will be utilized for the BBBO (blood-brain barrier opening) after each cycle of Aducanumab or Lecanemab administered per label.
Arms:
Infusion plus Exablate BBBO Treatment
Other names:
Focused Ultrasound
Lecanemab
Standard lecanemab therapy will be given by intravenous infusion every 2 weeks for up to 6 cycles with blood brain barrier opening
Arms:
Infusion plus Exablate BBBO Treatment
Other names:
Leqembi
Size
15
Primary endpoint
Treatment intervention related adverse events
From baseline, up to 5 year post last treatment
Treatment intervention related serious adverse events
From baseline, up to 5 year post last treatment
Eligibility 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
* 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)
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 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DEVICE_FEASIBILITY', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ESTIMATED'}}
Updated at
2024-02-20
1 organization
2 products
2 indications
Organization
Ali RezaiProduct
AducanumabIndication
Mild Cognitive ImpairmentIndication
Alzheimer DiseaseProduct
Lecanemab