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Monoclonal Antibodies
Aducanumab + Exablate BBB Disruption for Alzheimer's Disease
Phase < 1
Recruiting
Led By Ali Rezai, MD, FAANS
Research Sponsored by Ali Rezai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline, up to 5 year post last treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new treatment for early Alzheimer's disease and mild cognitive impairment. It combines a special drug with a technique to help the drug enter the brain more effectively. The goal is to see if this combination is safe and if it can reduce harmful brain proteins.
Who is the study for?
This trial is for people with mild Alzheimer's or cognitive impairment who can communicate during the procedure, have certain scores on mental and depression scales, a specific type of PET scan result, and a reliable caregiver. It excludes those with significant heart disease, liver issues, bleeding disorders, severe depression risk of suicide, untreated sleep apnea, epilepsy, impaired kidney function or are in another clinical trial.
What is being tested?
The study tests the safety of combining Aduhelm (Aducanumab) infusions with Exablate Model 4000 Type 2 device to open the blood-brain barrier in patients. The goal is to see if this combination is safe and feasible for treating mild Alzheimer's disease or cognitive impairment.
What are the potential side effects?
Potential side effects may include reactions related to opening the blood-brain barrier such as temporary discomfort or pain during treatment. There could also be risks associated with Aducanumab infusion like infusion-related reactions and imaging abnormalities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline, up to 5 year post last treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline, up to 5 year post last treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Treatment intervention related adverse events
Treatment intervention related serious adverse events
Secondary study objectives
Beta-Amyloid plaques within the brain
Cognitive performance (ADAS COG 11)
Cognitive performance (MMSE)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Infusion plus Exablate BBBO TreatmentExperimental Treatment3 Interventions
Intravenous infusion of Aducanumab or Lecanemab every 2-4 weeks (per standard of care) followed by blood brain barrier opening by FUS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aducanumab
2022
Completed Phase 3
~330
Lecanemab
2020
Completed Phase 3
~3530
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Monoclonal antibody infusion therapy targets specific proteins involved in Alzheimer's disease, such as amyloid-beta (Aβ) oligomers and plaques, to help clear them from the brain and potentially slow disease progression. The Exablate Model 4000 Type 2 device uses focused ultrasound to temporarily open the blood-brain barrier, enhancing the delivery of these therapeutic antibodies to the brain.
This combination aims to improve treatment efficacy by ensuring higher drug concentrations reach the affected areas, which is crucial for MCI patients as it offers a targeted approach to addressing the underlying pathology of cognitive decline.
Lessons Learnt from the Second Generation of Anti-Amyloid Monoclonal Antibodies Clinical Trials.
Lessons Learnt from the Second Generation of Anti-Amyloid Monoclonal Antibodies Clinical Trials.
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Who is running the clinical trial?
Ali RezaiLead Sponsor
4 Previous Clinical Trials
64 Total Patients Enrolled
InSightecIndustry Sponsor
91 Previous Clinical Trials
3,783 Total Patients Enrolled
Ali Rezai, MD, FAANSPrincipal InvestigatorWVU Rockerfeller Neuroscience Institute