Leronlimab for Alzheimer's Disease

(SALIENT-AD Trial)

Overseen By Alexus A. Jones, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Weill Medical College of Cornell University

Must be taking: Cholinesterase inhibitors, Memantine

Must not be taking: Benzodiazepines, NSAIDs

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Tracy A Butler, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

Inclusion Criteria

In the opinion of the investigator have adequate cognition, literacy, vision, and hearing for neuropsychological testing

The participant should have a study partner who can support the study participant and provide collateral information

Understands and agrees to comply with planned study procedures

Exclusion Criteria

I do not have a gene change or take medicines that could affect the PET scan results.

I do not have active Hepatitis B infection.

Significantly depressed (Geriatric Depression Scale > 10)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive leronlimab once a week for 12 weeks, with procedures including brain scans, lab work, and cognitive tests

12 weeks

12 visits (in-person or at home), weekly phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of brain inflammation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Leronlimab

How Is the Trial Designed?

Group I: Single arm Experimental Treatment 1 Intervention

All participants (N = 20) enrolled into this phase 2a, single-arm study will receive 12 doses of leronlimab.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

William H. Donner Foundation

Collaborator