ClinicalTrials.gg
RecruitingNCT07787169Updated Nov 5, 2026

A Master Protocol Studying Multiple Amyloid-Targeting Therapies in Healthy Participants and Participants With Alzheimer's Disease

A Phase 1 interventional study of LY4405094 and LY4405094 in Alzheimer Disease, Amyloid and Plaque, Amyloid, sponsored by Eli Lilly and Company. Recruiting at 19 sites in 3 countries. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Screening

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Nov 5, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
179
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Alzheimer Disease
  • Amyloid
  • Plaque, Amyloid
  • Healthy Volunteers
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 179 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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 (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 (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 (MMSE) score ≥16
  • Have positive amyloid positron emission tomography (PET)
  • Have a reliable study partner who will provide written 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, multiple or severe drug allergies or severe posttreatment 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 disease for 3 years.
  • Have received any amyloid-targeting therapy (ATT), whether marketed or ; 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:

  • 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.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 1
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
179 participants (estimated)

Study arms

  • Experimental
    LY4405094 Study AT01 (Healthy ISA)

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

    Drug: LY4405094 · Drug: Placebo

  • 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.

    Drug: LY4405094 · Drug: Placebo · Other: Florbetapir F18 · Other: Florbetaben F 18

Interventions

  • DrugLY4405094

    Administered intravenously (IV)

  • DrugLY4405094

    Administered Subcutaneously (SC)

  • DrugPlacebo

    Administered IV

  • DrugPlacebo

    Administered SC

  • OtherFlorbetapir F18

    Administered IV

  • OtherFlorbetaben F 18

    Administered IV

06

What researchers measure

Primary outcomes

  1. The number of participants allocated to each substudy

    Time frame: Baseline up to Day 160

07

Study locations

3 of 19 sites recruiting
  • CenExel ACT
    Anaheim, California 92801, United States
    Recruiting
    • · Contact714-774-7777
    • Amina Haggag · Principal investigator
  • Irvine Clinical Research
    Irvine, California 92614, United States
    Not yet recruiting
    • · Contact949-753-1663
    • Elly Lee · Principal investigator
  • Collaborative Neuroscience Network - CNS
    Los Alamitos, California 90720, United States
    Recruiting
    • · Contact714-799-7799
    • Steven Reynolds · Principal investigator
  • Fortrea Clinical Research Unit
    Daytona Beach, Florida 32117, United States
    Recruiting
    • · Contact386-366-6400
    • Chiamaka Iheme · Principal investigator
  • K2 Medical Research - The Villages
    Lady Lake, Florida 32159, United States
    Not yet recruiting
    • · Contact321-278-5590
    • Craig Curtis · Principal investigator
  • K2 Medical Research
    Maitland, Florida 32751, United States
    Not yet recruiting
    • · Contact407-232-9262
    • Brandon Lenox · Principal investigator
  • Charter Research
    Orlando, Florida 32803, United States
    Not yet recruiting
    • · Contact407-337-1000
    • Diana Balsalobre · Principal investigator
  • Progressive Medical Research
    Port Orange, Florida 32127, United States
    Not yet recruiting
    • · Contact386-304-7070
    • Alexander White · Principal investigator
  • Alzheimer's Research and Treatment Center
    Stuart, Florida 34996, United States
    Not yet recruiting
    • · Contact772-675-0000
    • Adam Falchook · Principal investigator
  • K2 Medical Research - Tampa
    Tampa, Florida 33634, United States
    Not yet recruiting
    • · Contact813-800-5252
    • Kelley Wilson · Principal investigator
  • Charter Research
    The Villages, Florida 32162-2698, United States
    Not yet recruiting
    • · Contact352-775-1000
    • Jeffrey Norton · Principal investigator
  • Accel Research Sites - NeuroStudies Clinical Research Unit
    Decatur, Georgia 30030, United States
    Not yet recruiting
    • · Contact404-475-0552
    • Marshall Nash · Principal investigator
  • QUEST Research Institute
    Farmington Hills, Michigan 48334, United States
    Not yet recruiting
    • · Contact248-957-8940
    • Aaron Ellenbogen · Principal investigator
  • Xuanwu Hospital Capital Medical University
    Beijing, 100053, China
    Not yet recruiting
    • Cuibai Wei · Principal investigator
  • Peking University Third Hospital
    Beijing, 100191, China
    Not yet recruiting
    • · Contact010-82265024
    • Dongsheng Fan · Principal investigator
  • Huashan Hospital, Fudan University
    Minhang District, 201107, China
    Not yet recruiting
    • · Contact021-54601999
    • Jintai Yu · Principal investigator
  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    Shanghai, 200127, China
    Not yet recruiting
    • Gang Wang · Principal investigator
  • The University of Tokyo Hospital
    Bunkyō City, 113-8655, Japan
    Not yet recruiting
    • · Contact81120023812
    • Yoshiki Niimi · Principal investigator
  • National Center for Geriatrics and Gerontology
    Ōbu, 4748511, Japan
    Not yet recruiting
    • · Contact81120023812
    • Keisuke Suzuki · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 8, 2026
Sites
3 sites added. 16 sites changed recruiting status (13 now not yet recruiting, 3 now recruiting)
Show 16 sites
  • CenExel ACT · Anaheim, United Statesno status→Recruiting
  • Irvine Clinical Research · Irvine, United Statesno status→Not yet recruiting
  • Collaborative Neuroscience Network - CNS · Los Alamitos, United Statesno status→Recruiting
  • Fortrea Clinical Research Unit · Daytona Beach, United Statesno status→Recruiting
  • K2 Medical Research - The Villages · Lady Lake, United Statesno status→Not yet recruiting
  • K2 Medical Research · Maitland, United Statesno status→Not yet recruiting
  • Charter Research · Orlando, United Statesno status→Not yet recruiting
  • Progressive Medical Research · Port Orange, United Statesno status→Not yet recruiting
  • Alzheimer's Research and Treatment Center · Stuart, United Statesno status→Not yet recruiting
  • K2 Medical Research - Tampa · Tampa, United Statesno status→Not yet recruiting
  • Charter Research · The Villages, United Statesno status→Not yet recruiting
  • Accel Research Sites - NeuroStudies Clinical Research Unit · Decatur, United Statesno status→Not yet recruiting
  • QUEST Research Institute · Farmington Hills, United Statesno status→Not yet recruiting
  • Xuanwu Hospital Capital Medical University · Beijing, Chinano status→Not yet recruiting
  • The University of Tokyo Hospital · Bunkyō City, Japanno status→Not yet recruiting
  • National Center for Geriatrics and Gerontology · Ōbu, Japanno status→Not yet recruiting
Show 3 added (3 China)
  • Huashan Hospital, Fudan University · Minhang District, China
  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine · Shanghai, China
  • Peking University Third Hospital · Beijing, China
across 2 updates, Oct 8, 2026 – Nov 5, 2026
Show all 2 updates
  1. Nov 5, 2026
    1 site added. 2 sites changed recruiting status (2 now recruiting)
    Show 2 sites
    • CenExel ACT · Anaheim, United StatesNot yet recruiting→Recruiting
    • Collaborative Neuroscience Network - CNS · Los Alamitos, United StatesNot yet recruiting→Recruiting
    Show site
    • Peking University Third Hospital · Beijing, China
    + 1 other change: verification date
  2. Oct 8, 2026
    Not yet recruiting→Recruiting
    2 sites added. 16 sites changed recruiting status (15 now not yet recruiting, 1 now recruiting)
    Show 16 sites
    • CenExel ACT · Anaheim, United Statesno status→Not yet recruiting
    • Irvine Clinical Research · Irvine, United Statesno status→Not yet recruiting
    • Collaborative Neuroscience Network - CNS · Los Alamitos, United Statesno status→Not yet recruiting
    • Fortrea Clinical Research Unit · Daytona Beach, United Statesno status→Recruiting
    • K2 Medical Research - The Villages · Lady Lake, United Statesno status→Not yet recruiting
    • K2 Medical Research · Maitland, United Statesno status→Not yet recruiting
    • Charter Research · Orlando, United Statesno status→Not yet recruiting
    • Progressive Medical Research · Port Orange, United Statesno status→Not yet recruiting
    • Alzheimer's Research and Treatment Center · Stuart, United Statesno status→Not yet recruiting
    • K2 Medical Research - Tampa · Tampa, United Statesno status→Not yet recruiting
    • Charter Research · The Villages, United Statesno status→Not yet recruiting
    • Accel Research Sites - NeuroStudies Clinical Research Unit · Decatur, United Statesno status→Not yet recruiting
    • QUEST Research Institute · Farmington Hills, United Statesno status→Not yet recruiting
    • Xuanwu Hospital Capital Medical University · Beijing, Chinano status→Not yet recruiting
    • The University of Tokyo Hospital · Bunkyō City, Japanno status→Not yet recruiting
    • National Center for Geriatrics and Gerontology · Ōbu, Japanno status→Not yet recruiting
    Show 2 added (2 China)
    • Huashan Hospital, Fudan University · Minhang District, China
    • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine · Shanghai, China
    + 3 other changes: identifiers, verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07787169
Responsible party
Sponsor
First posted
Aug 26, 2026
Start date
Sep 9, 2026
Primary completion
Jul 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Nov 5, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion