Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for Mild Cognitive Impairment o… (NCT05469009) | Clinical Trial Compass
Active — 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
United States15 participantsStarted 2022-07-14
Plain-language summary
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).
Who can participate
Age range
50 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Respira…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment intervention related adverse events
Timeframe: From baseline, up to 5 year post last treatment
2
Treatment intervention related serious adverse events
Timeframe: From baseline, up to 5 year post last treatment