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

Part of paid clinical trials in Morgantown, West Virginia.

Sponsor
Ali Rezai
Study ID
NCT05469009
Phase
EARLY_PHASE1
Status
Active Not Recruiting

Conditions

  • Alzheimer Disease 1
  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Aducanumab — DRUG
    Standard aducanumab therapy will be given by intravenous infusion every 4 weeks for 6 cycles with blood brain barrier opening
  • Exablate Model 4000 Type 2 — DEVICE
    The Exablate Model 4000 will be utilized for the BBBO (blood-brain barrier opening) after each cycle of Aducanumab or Lecanemab administered per label.
  • Lecanemab — DRUG
    Standard lecanemab therapy will be given by intravenous infusion every 2 weeks for up to 6 cycles with blood brain barrier opening

Study Details

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).

Key Dates

Start date
Jul 14, 2022
Status verified
Nov 2025
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Infusion plus Exablate BBBO Treatment
    Intravenous infusion of Aducanumab or Lecanemab every 2-4 weeks (per standard of care) followed by blood brain barrier opening by FUS.

Primary Outcome Measure

Treatment intervention related adverse events [ Time Frame: From baseline, up to 5 year post last treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
West Virginia University Rockefeller Neuroscience InstituteMorgantownWest Virginia26506-

Find similar trials in Morgantown, WV

By research site
West Virginia University Rockefeller Neuroscience Institute· Morgantown, WV

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