LY3439539 for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how the experimental drug LY3439539 affects proteins in the spinal fluid of people with Alzheimer's disease. The goal is to determine if this new treatment can alter protein levels associated with Alzheimer's. Participants should have experienced memory changes for at least six months that align with Alzheimer's symptoms. The trial requires monthly visits over nine months and seeks individuals who can actively engage in the study process. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop taking my current medications for this trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on amyloid-targeting therapies or have received certain biologic treatments recently. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that LY3439539 is likely to be safe for humans?
A previous study tested LY3439539 in people with Alzheimer's disease. The study found that most participants tolerated the treatment well, with no serious problems reported. Although specific side effects were not listed, a data safety and monitoring board ensured safety remained a priority. They closely monitored for any serious unwanted effects from the treatment. As this trial is in its earliest phase, the primary focus is on assessing the treatment's safety for humans. This early phase means limited safety information is available, but the study is designed to identify and address any issues that arise.12345
Why do researchers think this study treatment might be promising for Alzheimer's?
Unlike the standard treatments for Alzheimer's disease, which primarily focus on managing symptoms through medications like cholinesterase inhibitors and memantine, LY3439539 offers a fresh approach. This experimental treatment is administered intravenously, which may allow for more precise dosing and potentially faster action compared to oral medications. Researchers are particularly excited about LY3439539 because it might target underlying disease mechanisms rather than just alleviating symptoms, offering hope for more effective management of Alzheimer's disease.
What evidence suggests that LY3439539 might be an effective treatment for Alzheimer's?
Research suggests that LY3439539, the investigational treatment in this trial, might help treat Alzheimer's disease by affecting certain proteins in the spinal fluid. Studies have shown that drugs like LY3439539 can slow memory and thinking problems in people with early Alzheimer's. Specifically, one study showed a 60% reduction in the decline of patients with early-stage Alzheimer's, which is encouraging. In this trial, LY3439539 is administered through an IV (a drip into the vein) and aims to change the levels of specific proteins linked to Alzheimer's. While researchers are still collecting exact data on LY3439539, early signs suggest it could help slow the disease's progression.13678
Who Is on the Research Team?
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for adults with mild to moderate Alzheimer's disease who have had memory problems for at least 6 months, score between 16 and 24 on a mental status test, meet certain blood test criteria, have a BMI between 17 and 32, are not able to become pregnant (or use contraception), and can bring one or two study partners.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive LY3439539 intravenously to assess changes in cerebrospinal fluid biomarkers
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY3439539
Trial Overview
The study is testing LY3439539, an experimental drug, to see how it affects specific proteins in the spinal fluid of people with Alzheimer's. Participants will visit the clinic about once a month over roughly nine months.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
LY3439539 administered intravenously (IV)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Citations
A Study of LY3439539 in Participants With Alzheimer's ...
Most clinical studies have one primary outcome measure, but some have more than one. ... The main reason for the clinical trial. The types of primary purpose are: ...
A Study of LY3439539 in Participants With Alzheimer's Disease
The purpose of this study is to see how LY3439539 affects certain proteins found in the spinal fluid of participants with Alzheimer's disease. ...
Clinical trials of new drugs for Alzheimer disease - PMC - NIH
The drug notably reduced decline by 60% in patients with early-stage AD, supporting the efficacy of short-term dosing. Twenty-four outcomes were evaluated,
4.
opentrials.com
opentrials.com/clinical-trials/a-study-of-ly3439539-in-participants-with-alzheimers-disease-nb24dky5A Study of LY3439539 in Participants With Alzheimer's Disease
The purpose of this study is to see how LY3439539 affects certain proteins found in the spinal fluid of participants with Alzheimer's disease.
5.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/2519649/eli-lilly-advances-new-alzheimers-drug-ly3439539-into-phase-1-what-investors-should-watch/Eli Lilly Advances New Alzheimer's Drug LY3439539 Into ...
LY3439539 is an experimental drug given by intravenous infusion. It is designed to change levels of certain proteins in spinal fluid that are ...
Updated safety results from phase 3 lecanemab study in early ...
Lecanemab has been shown to be well tolerated in multiple clinical trials, although risks include an increased rate of amyloid-related imaging abnormalities ( ...
NCT05063539 | A Study of LY3372689 to Assess the ...
The purpose of this study is to assess the safety, tolerability and effect of study drug LY3372689 in participants with early symptomatic Alzheimer's Disease
Questions over safety and effectiveness of new Alzheimer's ...
Investigation raises concerns about excess deaths, missing safety data, questionable effectiveness, and financial ties among expert advisors.
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