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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

Study Summary

This trial will test if giving the monthly Aduhelm infusion therapy to patients with mild Alzheimer's disease or mild cognitive impairment, in combination with opening the blood-brain barrier, is safe and feasible.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~from baseline, up to 5 year post last treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline, up to 5 year post last treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment intervention related adverse events
Treatment intervention related serious adverse events
Secondary outcome measures
Beta-Amyloid plaques within the brain
Cognitive performance (ADAS COG 11)
Cognitive performance (MMSE)

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
2022
Completed Phase 1
~220

Find a Location

Who is running the clinical trial?

Ali RezaiLead Sponsor
3 Previous Clinical Trials
49 Total Patients Enrolled
InSightecIndustry Sponsor
89 Previous Clinical Trials
3,699 Total Patients Enrolled
Ali Rezai, MD, FAANSPrincipal InvestigatorWVU Rockerfeller Neuroscience Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include participants who are over the age of 45?

"Eligibility for this research study is restricted to those aged between 50-85. In contrast, there are 43 trials for those under 18 and 957 for those over 65."

Answered by AI

If a patient were interested, could they join this clinical trial at this time?

"That is accurate. The clinical trial in question is recruiting participants, as stated on clinicaltrials.gov. This clinical trial was posted on 7/14/2022 and was last edited on 8/17/2022. They are looking for 5 participants from 1 location."

Answered by AI

Are patients with a certain health condition able to participate in this research?

"This research is looking for 5 individuals aged 50-85 that have mild cognitive impairment. The most crucial applicants will be those that can provide informed consent, have probable mild cognitive impairment due to Alzheimer's disease, have a Modified Hachinski Ischemia Scale score of 4 or lower, have a Mini Mental State Exam score of 21 or higher, have a Short form Geriatric Depression Scale score of 7 or lower, have an amyloid PET scan consistent with the presence of beta-amyloid, be able to communicate during the Exablate MRgFUS procedure, and are able to attend all study visits with a life expectancy"

Answered by AI

Who else is applying?

What site did they apply to?
West Virginia University Rockefeller Neuroscience Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I had a severe head injury in 1995 resulting in MCI. I have been looking for a Study to help in this area.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
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
Ali Rezai 2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05469009.
All > Mild Cognitive Impairment
~10 spots leftby Jul 2029
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