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NCT05469009 · ClinicalTrials.gov registry record · Early Phase 1
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
A Early Phase 1 study of Mild Cognitive Impairment and Alzheimer Disease 1, sponsored by Ali Rezai.
- Active
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05469009 is a Early Phase 1 study of Mild Cognitive Impairment and Alzheimer Disease 1 that is active but no longer recruiting, run by Ali Rezai. The registered enrollment target is 15 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05469009, a Early Phase 1 study of Mild Cognitive Impairment and Alzheimer Disease 1, is active but no longer recruiting, sponsored by Ali Rezai.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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).
Conditions Studied
Interventions
- DRUG Lecanemab
- DRUG Aducanumab
- DEVICE Exablate Model 4000 Type 2
Study Locations (1)
West Virginia
- West Virginia University Rockefeller Neuroscience Institute - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-07-14 |
| Est. Completion | 2029-07 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05469009
The ClinicalTrials.gov registry entry for NCT05469009 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (99% lower). The listed sponsor is Ali Rezai, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 3 interventions - of which Lecanemab is the first listed.
NCT05469009 reports 1 study location spanning 1 distinct geographic area - top geographies include West Virginia.
Frequently Asked Questions
What is clinical trial NCT05469009 about?
NCT05469009 is a clinical study titled "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". 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 cogniti...
What is the current status of trial NCT05469009?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2022-07-14. Estimated completion is 2029-07.
What conditions does trial NCT05469009 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Alzheimer Disease 1.
What interventions are being tested in trial NCT05469009?
The interventions under investigation include: Lecanemab (DRUG), Aducanumab (DRUG), Exablate Model 4000 Type 2 (DEVICE).
Who is sponsoring clinical trial NCT05469009?
This trial is sponsored by Ali Rezai, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05469009 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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