drugset / Trial / 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
NaSingle-groupOpen-labelDevice feasibility
Summary
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).
Timeline
- Start
- 2022-07-14
- Primary completion
- 2029-07
- Completion
- 2029-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Aducanumab | Monoclonal antibody | — | Intravenous |
| Background | Lecanemab | Monoclonal antibody | — | Intravenous |