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Safety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease

NCT07553338 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-22

No results posted yet for this 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.

Conditions

Interventions

DRUG

Leronlimab (700mg)

Leronlimab, also known as PRO 140, is a humanized IgG4κ monoclonal antibody to Chemokine Receptor type 5 (CCR5). It is currently in development to potentially treat a number of different diseases, including but not limited to, metastatic colorectal cancer (mCRC), triple-negative breast cancer (TNBC), and other oncological conditions.

Sponsors & Collaborators

  • William H. Donner Foundation

    collaborator UNKNOWN

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Tracy A Butler, MD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-11-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07553338 on ClinicalTrials.gov