Infusion plus Exablate BBBO Treatment for Mild Cognitive Impairment (MCI)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
West Virginia University Rockefeller Neuroscience Institute, Morgantown, WV
Mild Cognitive Impairment (MCI)+3 More
Aducanumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to assess the safety and feasibility of administering standard of care monthly Aduhelm (Aducanumab) 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).

Eligible Conditions

  • Mild Cognitive Impairment (MCI)
  • Alzheimer Disease 1

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Mild Cognitive Impairment (MCI)

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: From baseline, up to 5 year post last treatment

Year 5
Beta-Amyloid plaques within the brain
Cognitive performance (ADAS COG 11)
Cognitive performance (MMSE)
Treatment intervention related adverse events
Treatment intervention related serious adverse events

Trial Safety

Safety Progress

1 of 3

Other trials for Mild Cognitive Impairment (MCI)

Trial Design

1 Treatment Group

Infusion plus Exablate BBBO Treatment
1 of 1
Experimental Treatment

5 Total Participants · 1 Treatment Group

Primary Treatment: Infusion plus Exablate BBBO Treatment · No Placebo Group · Phase < 1

Infusion plus Exablate BBBO TreatmentExperimental Group · 2 Interventions: Aducanumab, Exablate Model 4000 Type 2 · Intervention Types: Drug, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aducanumab
2022
Completed Phase 1
~180

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline, up to 5 year post last treatment
Closest Location: West Virginia University Rockefeller Neuroscience Institute · Morgantown, WV
2021First Recorded Clinical Trial
1 TrialsResearching Mild Cognitive Impairment (MCI)
2 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a positive scan consistent with the presence of β-amyloid (A+).
You are able to communicate sensations during the Exablate MRgFUS procedure.
You are able to attend all study visits.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.