Recruiting
Phase 1

Observational Study

Sponsor:

Eli Lilly and Company

Code:

NCT07787169

Conditions

Alzheimer Disease

Amyloid

Plaque, Amyloid

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

LY4405094

LY4405094

Placebo

Placebo

Florbetapir F18

Study Details

Brief summary:

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).

Conditions

Alzheimer Disease

Amyloid

Plaque, Amyloid

Healthy Volunteers

Study ID

NCT07787169

Start date

Sep 9, 2026

Status verified date

Oct, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Participants must meet eligibility criteria below. Additional criteria are specified in the substudy to which the participant will enroll.

Inclusion Criteria for Healthy Participants:

  • Are between 18 and 45 years of age
  • Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²)
  • Are overtly healthy as determined by medical evaluation, including medical history, physical examination, and electrocardiograms (ECGs).

Inclusion Criteria for Participants with Alzheimer's Disease (AD):

  • Are between 55-85 years of age
  • Have gradual and progressive changes in memory function, as reported by the participant or their study partner, for greater than or equal to (≥) 6 months at screening, as well as a clinical diagnosis of mild cognitive impairment due to AD or mild-to-moderate AD dementia as determined by the investigator or based on medical history.
  • Have Mini-Mental State Exam (MMSE) score ≥16
  • Have positive amyloid positron emission tomography (PET)
  • Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant. A second person may serve as backup.
  • For participants on symptomatic treatments for AD (for example, cholinesterase inhibitors, memantine) the dosing regimen must be stable, in the opinion of the investigator, for at least 8 weeks before randomization to a study intervention, and the dosing regimen is planned to remain stable.

Exclusion Criteria for all Participants:

  • Have currently, or a history of, serious or unstable neurological or psychological disease (except for AD for participants in the AD cohorts).
  • Have currently, or a history of, significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological diseases.
  • Have currently, or a history of, allergies to monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone.
  • Have currently, or a history of, clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions.
  • Have currently, or a history of cancer within the past 5 years except for some early skin cancers that have been resected with no evidence of metastatic disease for 3 years.
  • Have received any amyloid-targeting therapy (ATT), whether marketed or investigational; or have received active immunization against amyloid beta (Aβ).
  • Have received an active study intervention, within the last 30 days, in a clinical study involving an IMP.
  • Are pregnant or breastfeeding or intend to become pregnant or to breastfeed during the study;
  • Have an abnormal blood pressure, pulse rate, or both, as determined by the investigator, or a preexisting history of hypertension.

Exclusion Criteria for Healthy Participants:

  • Have a locally read brain magnetic resonance imaging (MRI) that demonstrates any clinically significant findings, including but not limited to, findings suggestive of CAA, that, in the opinion of the investigator, may impact the participant's ability to safely participate in the study.
  • Have a history of clinically significant back pain, pathological conditions of the back, or back injury (for example, degenerative disease, spinal deformity, or spinal surgery), or have a local infection at the intended site of the lumbar puncture (LP) that may predispose to complications or technical difficulty with LP.
  • Have a family history of early onset AD (AD diagnosed before 65 years of age).

Exclusion Criteria for Participants with AD:

  • Contraindications or unable to tolerate MRI
  • Have a centrally read brain MRI that demonstrates the presence of Amyloid-Related Imaging Abnormalities with Edema/Effusion (ARIA-E), greater than (>)4 cerebral microhemorrhages, any evidence of superficial siderosis, any macrohemorrhage, or severe white matter disease; >2 lacunar infarcts or any territorial infarct >1 square centimeters (cm²); significant abnormalities that suggest another potential etiology for progressive dementia, or clinically significant finding that, in the opinion of the investigator, may impact the participant's ability to safely participate in the study.
  • Contraindications to amyloid PET scan.

Study Design

Enrollment

179 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: LY4405094 Study AT01 (Healthy ISA)

LY4405094 or placebo administered intravenously (IV) or subcutaneously (SC) in healthy volunteers.

experimental: LY4405094 Study AT01 (AD ISA)

LY4405094 or placebo administered IV to participants with AD. Florbetapir F 18 or Florbetaben F 18 will be administered IV during amyloid positron emission tomography (PET) scan.

Interventions

LY4405094

Administered intravenously (IV)

LY4405094

Administered Subcutaneously (SC)

Placebo

Administered IV

Placebo

Administered SC

Florbetapir F18

Administered IV

Florbetaben F 18

Administered IV

Primary outcome measure

  • The number of participants allocated to each substudy [ Time Frame: Baseline up to Day 160 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Fortrea Clinical Research Unit

Recruiting

Daytona Beach, Florida, United States, 32117

Contacts

Principal Investigator:

Chiamaka Iheme

More Information

Sponsor

Eli Lilly and Company

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.