LY4560736 for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a new drug, LY4560736, to assess its safety and behavior in the body, focusing on Alzheimer's disease. It includes two groups: healthy participants and those with Alzheimer's. The trial will evaluate how the drug enters and affects the brain and measure a specific Alzheimer's-related protein. This trial may suit individuals with Alzheimer's who are of Japanese or Chinese descent and are not experiencing active infections or taking certain antibody treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that LY4560736 is likely to be safe for humans?
Research has shown that LY4560736 is a new treatment under testing for Alzheimer's disease. This study is in its early stages, focusing on the treatment's safety and tolerability. Since LY4560736 is being tested in humans for the first time, limited safety information is available.
In early trials like this, researchers monitor how the body reacts to the treatment and identify any side effects. Participants receive close observation for any negative reactions. If similar treatments had been found unsafe in past studies, they would not reach this stage. While specific safety data for LY4560736 is not yet available, testing it in humans indicates it has passed some initial safety checks. However, participants should understand that early clinical trials involve certain risks.12345Why do researchers think this study treatment might be promising for Alzheimer's?
Unlike the standard Alzheimer's treatments, which often focus on managing symptoms using cholinesterase inhibitors or NMDA receptor antagonists, LY4560736 offers a fresh approach. Researchers are excited about LY4560736 because it could potentially address the underlying disease mechanisms by targeting amyloid deposits, a key feature of Alzheimer's. This treatment stands out due to its novel delivery methods—administered either intravenously or subcutaneously—and its use of advanced imaging techniques like amyloid PET scans to assess its effects. These unique features could pave the way for a more precise and effective treatment option for Alzheimer's patients.
What evidence suggests that LY4560736 could be an effective treatment for Alzheimer's Disease?
Research has shown that LY4560736 might help treat Alzheimer's disease by targeting amyloid plaques in the brain. These plaques, clumps of protein, often appear in the brains of people with Alzheimer's. Early studies suggest that treatments like LY4560736 can reduce these plaques, as observed in PET scans, a type of brain imaging. In this trial, participants will receive either LY4560736 or a placebo to evaluate its effectiveness. Although researchers are still studying LY4560736, other similar treatments have shown promise in slowing the disease. By lowering amyloid levels, LY4560736 might improve memory and thinking skills in people with Alzheimer's.678910
Who Is on the Research Team?
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Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for healthy adults and people diagnosed with Alzheimer's disease. Participants must be able to stay at the research center as required, and Japanese (and possibly Chinese) individuals may be included. People with certain health issues or who can't safely participate will not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single-Ascending Dose (SAD) Treatment
LY4560736 administered intravenously (IV) or subcutaneously (SC) in healthy volunteers
Multiple Ascending Dose (MAD) Treatment
LY4560736 administered IV to participants with Alzheimer's Disease, including amyloid PET scan
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY4560736
Trial Overview
The study tests a new drug called LY4560736 compared to a placebo in both healthy volunteers and those with Alzheimer's disease. It also uses brain scans (Florbetapir F18 or Florbetaben F18) to measure Alzheimer’s-related proteins. The main focus is on safety and how the drug moves through the body.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Placebo Group
LY4560736 administered IV to participants with AD. Florbetapir F 18 or Florbetaben F 18 will be administered IV during amyloid positron emission tomography (PET) scan.
LY4560736 administered intravenously (IV) or subcutaneously (SC) in healthy volunteers.
Placebo administered IV or SC in healthy volunteers.
Placebo administered IV to participants with AD. Florbetapir F 18 or Florbetaben F 18 will be administered IV during amyloid PET scan.
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
J Prev Alz Dis 2026;2(13)
... ALZHEIMER'S DISEASE DEMENTIA: RESULTS FROM A PHASE 2 RANDOMIZED CLINICAL TRIAL ... ALZHEIMER'S DISEASE (STOMP-AD): A PILOT CLINICAL TRIAL, J Prev Alz Dis 2022;1 ...
2.
jpreventionalzheimer.com
jpreventionalzheimer.com/6111-the-future-of-ad-clinical-trials-with-the-advent-of-anti-amyloid-therapies-an-ctad-task-force-report.htmlTHE FUTURE OF AD CLINICAL TRIALS WITH ...
Recently, aducanumab (ADUHELMTM) was approved for the treatment of Alzheimer's disease (AD) in the United States (US). This anti-amyloid ...
3.
researchgate.net
researchgate.net/publication/342386846_Longitudinal_Sensitivity_of_Alzheimer's_Disease_Severity_StagingLongitudinal Sensitivity of Alzheimer's Disease Severity ...
This research evaluates sensitivity and determinants of AD stage changes longitudinally using current classifications of “mild,” “moderate,” and ...
Leveraging 30 years of Alzheimer's disease clinical trials ...
These clinical trials largely followed a harmonized set of outcomes focused on cognition and function, with a large subset containing neuroimaging and fluid ...
Abstract Details
Donanemab treatment was associated with significant beneficial effects on: 1) iADRS cognitive items related to episodic memory and executive function, and ...
Anti-Aß immunotherapy in Alzheimer's disease - PMC - NIH
Therapeutic approaches to the treatment of Alzheimer's disease are focused primarily on the Aß peptide which aggregates to form amyloid deposits in the ...
7.
researchgate.net
researchgate.net/publication/23163682_Phase_2_Safety_Trial_Targeting_Amyloid_b_Production_With_a_g-Secretase_Inhibitor_in_Alzheimer_Disease(PDF) Phase 2 Safety Trial Targeting Amyloid β Production ...
Objective To evaluate the safety, tolerability, and amyloid β (Aβ) response to the γ-secretase inhibitor LY450139 in Alzheimer disease.
Selenofuranoside Ameliorates Memory Loss in Alzheimer ...
Alzheimer's disease (AD) is becoming more common due to the increase in life expectancy. This study evaluated the effect of selenofuranoside (Se) in an ...
9.
researchgate.net
researchgate.net/publication/362398752_Aducanumab_for_Alzheimer's_Disease_Summarized_Data_From_EMERGE_ENGAGE_and_PRIME_StudiesAducanumab for Alzheimer's Disease: Summarized Data ...
Aducanumab, a monoclonal antibody targeting amyloid-beta, became the first disease-modifying treatment for mild cognitive impairment due to Alzheimer's disease ...
10.
practicalneurology.com
practicalneurology.com/diseases-diagnoses/alzheimer-disease-dementias/dementia-insights-antiamyloid-antibody-therapy-in-alzheimer-disease/31928/Dementia Insights: Antiamyloid Antibody Therapy in Alzheimer
The saga continues for development of antiamyloid monoclonal antibodies, aducanumab, lecanemab, donanemab, and gantenerumab for Alzheimer disease.
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