An Early Phase 1 interventional study of Aducanumab and Exablate Model 4000 Type 2 in Mild Cognitive Impairment and Alzheimer Disease 1, sponsored by Ali Rezai. Active, not recruiting at 1 site in United States. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Ali Rezai · Early Phase 1, Interventional, and Device feasibility
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).
The primary objectives of this study is to evaluate the safety and feasibility of BBBO (blood-brain barrier opening) using the Exablate Model 4000 Type 2 in the setting of standard aducanumab or lecanemab therapy among patients with mild cognitive impairment (MCI) or mild Alzheimer's disease (AD) with confirmed β-amyloid, who are eligible for aducanumab or lecanemab infusion therapy, and to also evaluate the safety of the BBO procedure through patient examination (neurological and cognitive/behavioral) and MRI assessments during the treatment and follow-up.
The secondary objectives of this study is to determine the effect of BBBO in patients with MCI or mild AD treated with aducanumab or lecanemab on brain β-amyloid plaque measured by amyloid positron emission tomography (PET), as well as to assess the clinical impact of BBBO with standard aducanumab or lecanemab therapy, if any, as assessed with ADAS Cog 11 and MMSE over time following BBBO.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 15 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Ali Rezai is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous infusion of Aducanumab or Lecanemab every 2-4 weeks (per standard of care) followed by blood brain barrier opening by FUS.
Drug: Aducanumab · Device: Exablate Model 4000 Type 2 · Drug: Lecanemab
Standard aducanumab therapy will be given by intravenous infusion every 4 weeks for 6 cycles with blood brain barrier opening
Also known as: Aduhelm
The Exablate Model 4000 will be utilized for the BBBO (blood-brain barrier opening) after each cycle of Aducanumab or Lecanemab administered per label.
Also known as: Focused Ultrasound
Standard lecanemab therapy will be given by intravenous infusion every 2 weeks for up to 6 cycles with blood brain barrier opening
Also known as: Leqembi
Treatment intervention related adverse events
The total number of adverse events following each treatment through end of the study
Time frame: From baseline, up to 5 year post last treatment
Treatment intervention related serious adverse events
The total number of serious adverse events following each treatment through end of the study
Time frame: From baseline, up to 5 year post last treatment
Beta-Amyloid plaques within the brain
Beta-Amyloid uptake value measured by Amyloid PET scan
Time frame: From baseline, up to 5 year post last treatment
Cognitive performance (ADAS COG 11)
Change in cognitive performance using the Alzheimer's Disease Assessment Cognitive Subscale, rating scores from 0-70. The greater the dysfunction, the greater the score. A score of 70 represents the most severe impairment and 0 represents the least impairment.
Time frame: From baseline, up to 5 year post last treatment
Cognitive performance (MMSE)
Change in cognitive performance using the Mini Mental Status Exam, rating scores from 0-30. 25 or higher being classed as normal. A score below 24 is considered abnormal, indicating possible cognitive impairment.
Time frame: From baseline, up to 5 year post last treatment
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Ali Rezai