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NCT07553338 · ClinicalTrials.gov registry record · Phase 2
Safety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease
A Phase 2 study, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT07553338: Recruiting Phase 2 study, sponsored by Weill Medical College of Cornell University.
NCT07553338 is a Phase 2 study that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07553338, a Phase 2 study, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The present study will administer the drug leronlimab to 20 participants who are above 50 years old with Alzheimer's disease (AD) or mild cognitive impairment (MCI) due to AD. While leronlimab is considered safe in other diseases like Human Immunodeficiency Virus (HIV) and certain types of cancer, its safety and tolerability in AD will be tested for the first time. The main purpose of this study is to learn: 1. Is this drug safe for participants with AD and MCI due to AD? 2. Does leronlimab change levels of brain inflammation? The results of this study could lead to future studies with more participants that will test whether leronlimab may slow or prevent the decline in thinking abilities and brain function in this group of participants. Using leronlimab for Alzheimer's disease is experimental, which means that the Food and Drug Administration (FDA) has not approved leronlimab for this purpose. Participants will be asked to take leronlimab once a week for 12 weeks in our clinic or in their own home. Participants will also be asked to complete the below procedures before and after taking leronlimab for 12 weeks: 1. Undergo 2 types of brain scans, Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). 2. Visit our clinic for routine lab work, an electrocardiogram (ECG), and a physical exam. 3. Donate blood so the researchers can better understand how leronlimab affects levels of inflammation and proteins related to AD in the blood. 4. Undergo a series of tests and questionnaires that test thinking abilities. 5. Have weekly phone calls with researchers to let them know if there are side effects while taking this drug.
Primary Outcome
The primary outcome measure is leronlimab's effect on brain inflammation using a PET tracer that measures translocator protein (TSPO) activation on microglia.
Interventions
- DRUG Leronlimab (700mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-04-30 |
| Est. Completion | 2027-11 |
| Phase | Phase 2 |
What NCT07553338 shows while recruiting
NCT07553338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Leronlimab (700mg) is the first listed.
NCT07553338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07553338 about?
NCT07553338 is a clinical study titled "Safety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease". The present study will administer the drug leronlimab to 20 participants who are above 50 years old with Alzheimer's disease (AD) or mild cognitive impairment (MCI) due to AD. While leronlimab is considered safe in other diseases like Human Immunodeficiency Virus (HIV) and certain types of cancer, i...
What is the current status of trial NCT07553338?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2026-04-30. Estimated completion is 2027-11.
What interventions are being tested in trial NCT07553338?
The interventions under investigation include: Leronlimab (700mg) (DRUG).
Who is sponsoring clinical trial NCT07553338?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07553338's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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