Assessing a new method to enhance Alzheimer's treatment by opening the blood-brain barrier
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
This study is testing a new way to help people with mild Alzheimer's by using a device to open the blood-brain barrier while they receive standard antibody treatment to see if it improves their brain health and thinking skills.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | West Virginia University Academic / other |
| Drugs / interventions | aducanumab, lecanemab |
| Locations | 1 site (Morgantown, West Virginia) |
| Trial ID | NCT05469009 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of using the Exablate Model 4000 Type 2 device to open the blood-brain barrier in patients with mild Alzheimer's disease or mild cognitive impairment while they receive standard monoclonal antibody therapy. The primary focus is on patients eligible for aducanumab or lecanemab infusion therapy, with assessments including neurological and cognitive evaluations, as well as MRI scans during and after treatment. Additionally, the study aims to measure the impact of this procedure on brain β-amyloid levels and cognitive function over time.
Who should consider this trial
Good fit: Ideal candidates are individuals with mild cognitive impairment or mild Alzheimer's disease who have confirmed β-amyloid presence and meet specific cognitive and health criteria.
Not a fit: Patients with significant cardiac issues, severe depression, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of existing Alzheimer's therapies by improving drug delivery to the brain.
How similar studies have performed: While this approach is innovative, similar studies exploring blood-brain barrier disruption have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Morgantown, West Virginia
- West Virginia University Rockefeller Neuroscience Institute — Morgantown, West Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Ali Rezai, MD, FAANS — WVU Rockerfeller Neuroscience Institute
- Study coordinator: Marc Haut, PhD
- Email: mhaut@hsc.wvu.edu
- Phone: 304-293-6276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.