Actively Recruiting
Safety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease
Led by Weill Medical College of Cornell University · Updated on 2026-05-13
20
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
W
William H. Donner Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 due to AD. While leronlimab is considered safe in other diseases like Human Immunodeficiency Virus (HIV) and certain types of breast 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 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 will taking this drug.
CONDITIONS
Official Title
Safety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males or females, 50 years of age and older
- Biomarker confirmed mild-to-moderate mild cognitive impairment or Alzheimer's disease (CDR 0.5 to 1.5)
- Cognition sufficient to participate in study procedures including cognitive testing (MoCA >11)
- Clinically normal resting 12-lead ECG at screening or abnormal but not clinically significant
- Written informed consent provided by participant or legally authorized representative
- Understands and agrees to comply with study procedures
- Stable dose of FDA approved drugs for AD symptoms for at least 12 weeks prior to baseline
- Stable dose of FDA approved drugs targeting brain amyloid for at least 12 weeks prior to baseline
- Stable dose or regimen of supplements or medical foods affecting brain function for at least 12 weeks prior to baseline
- Stable dose of permitted concomitant medications for at least 4 weeks prior to baseline unless investigator allows shorter duration
- Adequate cognition, literacy, vision, and hearing for neuropsychological testing
- Has a study partner who can support and provide collateral information
You will not qualify if you...
- Gene variation or clinical factors affecting PET radiotracer binding or signal
- Women who are pregnant or breastfeeding
- Females of childbearing potential not using highly effective contraception or acceptable alternative methods
- Male participants with female partners of childbearing potential not agreeing to abstinence or condom use plus partner contraception
- HIV positive participants
- Positive Hepatitis B surface antigen test
- Positive Hepatitis C RNA PCR test
- Significant brain diseases other than Alzheimer's disease
- Current substance abuse per DSM-5 criteria
- Significantly depressed (Geriatric Depression Scale >10)
- Contraindications to MRI or PET scanning
- Clinically significant abnormalities in physical exam, labs, vital signs, or ECG interfering with safety or study procedures
- Unstable or uncontrolled medical conditions that could affect safety or assessments
- Malignant neoplasms within 3 years except certain skin or localized prostate cancers
- Participation in other interventional clinical trials affecting study participation
- Recent use of investigational drugs for Alzheimer's within 12 months unless placebo
- History of allergic reactions to compounds similar to leronlimab
- Previous receipt of leronlimab
- Use of prohibited medications
- Inability to provide informed consent or comply with testing
- Visual or hearing impairments preventing accurate psychometric testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Weill Cornell Medicine Brain Health Imaging Institute
New York, New York, United States, 10065
Actively Recruiting
Research Team
E
Edward Spector, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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