Leronlimab for Alzheimer's Disease
(SALIENT-AD 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive leronlimab once a week for 12 weeks, with procedures including brain scans, lab work, and cognitive tests
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of brain inflammation
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
All participants (N = 20) enrolled into this phase 2a, single-arm study will receive 12 doses of leronlimab.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
William H. Donner Foundation
Collaborator
Citations
Safety Assessment of Leronlimab and Its Effect on Brain ...
The main purpose of this study is to learn: Is this drug safe for participants with AD and MCI due to AD? Does leronlimab change levels of brain ...
The effectiveness and value of lecanemab for early Alzheimer ...
Key model assumptions were that lecanemab was effective at slowing the progression of disease while a patient had MCI due to AD or mild AD and that patients ...
An investigator-initiated pilot study of leronlimab in patients ...
An investigator-initiated pilot study of leronlimab in patients with Alzheimer's Disease. Status: Planning. Phase of Trial: Phase II. Latest ...
4.
cytodyn.com
cytodyn.com/investors/news-events/press-releases/detail/619/may-2024-letter-to-shareholdersMay 2024 Letter to Shareholders
WARNING: Leronlimab has not received regulatory approval from the FDA. The potential risks and benefits are not known. Doctors and patients ...
Eisai shared Lecanemab's long-term benefits at CTAD
These data show that 46% of patients improved or had no decline, and 33% showed improvement from baseline on the CDR-SB. On the ADAS-Cog14 ...
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.
Safety profiles of lecanemab: A systematic review and meta ...
Safety profiles of lecanemab, an anti-amyloid-β antibody for the treatment of early Alzheimer's disease (AD), remain uncertain and may vary ...
Real-world safety profile of lecanemab: A disproportionality ...
Lecanemab is an FDA-approved monoclonal antibody targeting amyloid beta for the treatment of early Alzheimer's disease. · Clinical trials have reported risks ...
Eisai Presents New Data on the Relationship between Clinical ...
Eisai Presents New Data on the Relationship between Clinical, Biomarker and Safety Outcomes from the Lecanemab Phase 2b Study for Early ...
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