NCT05469009 - 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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 14, 2022

Primary Completion Date

July 31, 2029

Study Completion Date

July 31, 2029

Conditions

Mild Cognitive ImpairmentAlzheimer Disease 1

Interventions

DRUG

Aducanumab

Standard aducanumab therapy will be given by intravenous infusion every 4 weeks for 6 cycles with blood brain barrier opening

DEVICE

Exablate Model 4000 Type 2

The Exablate Model 4000 will be utilized for the BBBO (blood-brain barrier opening) after each cycle of Aducanumab or Lecanemab administered per label.

DRUG

Lecanemab

Standard lecanemab therapy will be given by intravenous infusion every 2 weeks for up to 6 cycles with blood brain barrier opening

Trial Locations (1)

26506

West Virginia University Rockefeller Neuroscience Institute, Morgantown