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Amyloid-Targeting Therapies for Alzheimer's Disease

Not yet recruiting at 15 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company
Must be taking: Cholinesterase inhibitors, Memantine
Must not be taking: Amyloid-targeting therapy
Disqualifiers: Neurological, Cardiovascular, Cancer, Hypertension, others
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?

The purpose of this Master Protocol is to support multiple studies looking at safety and tolerability of different drugs in healthy participants and participants with Alzheimer's disease, and if they remove clumps of protein (amyloid plaque) in the brain in participants with Alzheimer's Disease. Participants will enroll into either A1D-MC-AT01 (NCT07787182) or A1D-MC-AT02 (upcoming).

Who Is on the Research Team?

C1

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Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for healthy people and those diagnosed with Alzheimer's disease. Participants must meet specific health requirements, but detailed criteria are not provided here.

Inclusion Criteria

Participants with AD have Mini-Mental State Exam (MMSE) score ≥16
Healthy Participants have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²)
Participants with AD have positive amyloid positron emission tomography (PET)
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Exclusion Criteria

All Participants have currently or history of serious or unstable neurological or psychological disease (except AD for AD cohorts)
All Participants have currently or history of allergies to monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
All Participants have currently or history of clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4405094 or placebo administered intravenously (IV) or subcutaneously (SC) in healthy volunteers and participants with Alzheimer's disease. Florbetapir F 18 or Florbetaben F 18 will be administered IV during amyloid PET scan.

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY4405094

Trial Overview

The study tests several drugs that target amyloid plaques in the brain, including LY4405094 and imaging agents Florbetaben F18 and Florbetapir F18, compared to a placebo. The goal is to see if these treatments are safe and can reduce amyloid buildup.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: LY4405094 Study AT01 (Healthy ISA)Experimental Treatment2 Interventions
Group II: LY4405094 Study AT01 (AD ISA)Experimental Treatment4 Interventions

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

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