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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 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.
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.
Interventions
- DRUG Leronlimab (700mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-04-30 |
| Est. Completion | 2027-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07553338
The ClinicalTrials.gov registry entry for NCT07553338 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Leronlimab (700mg) is the first listed.
NCT07553338 reports 0 study locations.
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.
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