Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Early Phase 1 study of Mild Cognitive Impairment and Alzheimer Disease 1, sponsored by Ali Rezai.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The total number of adverse events following each treatment through end of the study
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 |
What the registry record for NCT05469009 still lists
NCT05469009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Mild Cognitive Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05469009's enrollment target sits among peer trials
15 188th of 205 higher than 13 of 205 other Mild Cognitive Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Cognitive Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease
RECRUITING · Early Phase 1
-
Effects of Nicotinamide Riboside on Bioenergetics and Oxidative Stress in Mild Cognitive Impairment/Alzheimer's Dementia
RECRUITING · Early Phase 1
-
Time-in-bed Restriction in Older Adults With Sleep Difficulties With and Without Risk for Alzheimer's Disease
RECRUITING · Early Phase 1
-
Transcranial Magnetic Stimulation Treatment for Alzheimer's Disease
RECRUITING · Early Phase 1
-
Multi-Center Development of a Novel Diagnostic Test for Alzheimer's Disease
ACTIVE NOT RECRUITING · Early Phase 1
-
Glutathione in Mild Cognitive Impairment
ACTIVE NOT RECRUITING · Early Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01889381 · 15 participants · Phase 2
Human Craniomaxillofacial Allotransplantation
- NCT02530073 · 15 participants · NA
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
- NCT02535936 · 15 participants · NA
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
- NCT02918474 · 15 participants · NA
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI