20 Participants NeededMy employer runs this trial

Leronlimab for Alzheimer's Disease

(SALIENT-AD Trial)

ES
AA
Overseen ByAlexus A. Jones, BS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Weill Medical College of Cornell University
Must be taking: Cholinesterase inhibitors, Memantine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of leronlimab, a drug used in other conditions like HIV, to determine its potential benefits for people with Alzheimer's disease or mild cognitive impairment from Alzheimer's. Researchers aim to assess whether leronlimab is safe and can reduce brain inflammation in these individuals. Those who have had Alzheimer's or mild cognitive impairment for a while and are on stable medication for at least 12 weeks might be suitable candidates for this study. Participants will take the drug once a week for 12 weeks and undergo various tests, including brain scans and cognitive assessments. As a Phase 2 trial, this research focuses on evaluating leronlimab's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Do I need to stop my current medications for the trial?

You may not need to stop your current medications, but you must be on a stable dose of any Alzheimer's medications, brain-targeting drugs, or supplements for at least 12 weeks before starting the trial. If you're on other allowed medications, they should be stable for at least 4 weeks unless the investigator decides otherwise.

Is there any evidence suggesting that leronlimab is likely to be safe for participants with Alzheimer's disease?

Research has shown that leronlimab is considered safe for treating other diseases, such as HIV and certain types of breast cancer. Although it has been tested in people before, it has not been specifically tested for Alzheimer's disease. While safety data for Alzheimer's patients is not yet available, its use in other conditions offers some reassurance. As a Phase 2 trial, the drug has demonstrated some safety in earlier studies, but researchers are still testing to confirm its safety and effects in this new patient group. Participants must report any side effects during the trial, and researchers will monitor for any new issues.12345

Why do researchers think this study treatment might be promising for Alzheimer's?

Unlike the standard treatments for Alzheimer’s disease, which often focus on managing symptoms with medications like cholinesterase inhibitors or memantine, leronlimab acts on a unique mechanism. Leronlimab is a monoclonal antibody that targets the CCR5 receptor, which is believed to play a role in neuroinflammation and neuronal damage in Alzheimer’s. Researchers are excited about leronlimab because it offers a novel approach by potentially reducing inflammation in the brain, which could slow disease progression and improve cognitive function. This distinct mechanism of action sets it apart from existing therapies and holds promise for a more effective treatment strategy.

What evidence suggests that leronlimab might be an effective treatment for Alzheimer's disease?

Research has shown that leronlimab, a drug also used for conditions like HIV, is under study for Alzheimer's disease (AD) in this trial. Although human data specifically for Alzheimer's is not yet available, leronlimab targets a protein called CCR5, which helps reduce inflammation. Since inflammation plays a key role in Alzheimer's, scientists believe leronlimab might help by lowering brain inflammation. While leronlimab is considered safe for other diseases, its exact effects on Alzheimer's patients remain under investigation. Early results appear promising, but further research is needed to confirm if it can slow memory and thinking problems.16789

Who Is on the Research Team?

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Tracy A Butler, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults aged 50 and older with mild cognitive impairment or Alzheimer's disease, who can complete thinking tests and have a supportive study partner. Participants must be generally healthy, on stable medications, not pregnant or breastfeeding, and able to undergo brain scans.

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
See 9 more

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)
See 19 more

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

Trial Overview

The study is testing the safety of leronlimab (700mg) given weekly for 12 weeks in people with Alzheimer's or mild cognitive impairment. Researchers will also see if it affects brain inflammation using scans and blood tests.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single armExperimental Treatment1 Intervention

Find a Clinic Near You

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

Citations

Safety Assessment of Leronlimab and Its Effect on Brain ...

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May 2024 Letter to Shareholders

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Long‐term safety and efficacy of lecanemab in early ... - PMC

No new safety signals were observed with low amyloid‐related imaging abnormalities (ARIA) rates similar to ARIA rates on placebo after 6 months.

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Safety profiles of lecanemab, an anti-amyloid-β antibody for the treatment of early Alzheimer's disease (AD), remain uncertain and may vary ...

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