30 Participants NeededMy employer runs this trial

LY3439539 for Alzheimer's Disease

Recruiting at 12 trial locations
Tq
Pi
Overseen ByPhysicians interested in becoming principal investigators please contact
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

C1

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

Have at least 1 and up to 2 study partners who are in frequent contact with the participant (at least 10 hours per week)
I am not able to have children or I will use effective birth control during the study.
Have a Mini Mental Score Examination score of 16 to 24, inclusive
See 4 more

Exclusion Criteria

Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker
Have a screening MRI that shows evidence of significant abnormality
Have history of suicidal behavior or a lifetime history of suicide attempt or acute suicidality
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3439539 intravenously to assess changes in cerebrospinal fluid biomarkers

9 months
Approximately 9 visits (in-person, once a month)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: LY3439539Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

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,

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.

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 ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38730496/

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.