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Alzheimer DiseasePhase 1NCT07787169

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

A Phase 1 study testing LY4405094, Florbetapir F18 and Florbetaben F 18 in people with Alzheimer Disease and Amyloid, run by Eli Lilly and Company at 18 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease, Amyloid, Plaque, Amyloid
What is being tested?
LY4405094, Florbetapir F18 and Florbetaben F 18
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
179 participants
Where
18 sitesin 3 countries
Study dates
9 Sep 2026to Jul 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.
  • 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).
  • 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.

Trial locations and contacts

18 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

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

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

18 sites in 3 countries

United States13 sites, 13 recruiting

  • CenExel ACT

    Anaheim, California, 92801

    714-774-7777

    Amina Haggag

    Not yet recruiting

  • Fortrea Clinical Research Unit

    Daytona Beach, Florida, 32117

    386-366-6400

    Chiamaka Iheme

    Recruiting

  • Accel Research Sites - NeuroStudies Clinical Research Unit

    Decatur, Georgia, 30030

    404-475-0552

    Marshall Nash

    Not yet recruiting

  • QUEST Research Institute

    Farmington Hills, Michigan, 48334

    248-957-8940

    Aaron Ellenbogen

    Not yet recruiting

  • Irvine Clinical Research

    Irvine, California, 92614

    949-753-1663

    Elly Lee

    Not yet recruiting

  • K2 Medical Research - The Villages

    Lady Lake, Florida, 32159

    321-278-5590

    Craig Curtis

    Not yet recruiting

  • Collaborative Neuroscience Network - CNS

    Los Alamitos, California, 90720

    714-799-7799

    Steven Reynolds

    Not yet recruiting

  • K2 Medical Research

    Maitland, Florida, 32751

    407-232-9262

    Brandon Lenox

    Not yet recruiting

  • Charter Research

    Orlando, Florida, 32803

    407-337-1000

    Diana Balsalobre

    Not yet recruiting

  • Progressive Medical Research

    Port Orange, Florida, 32127

    386-304-7070

    Alexander White

    Not yet recruiting

  • Alzheimer's Research and Treatment Center

    Stuart, Florida, 34996

    772-675-0000

    Adam Falchook

    Not yet recruiting

  • K2 Medical Research - Tampa

    Tampa, Florida, 33634

    813-800-5252

    Kelley Wilson

    Not yet recruiting

  • Charter Research

    The Villages, Florida, 32162-2698

    352-775-1000

    Jeffrey Norton

    Not yet recruiting

Other trials in United States

China3 sites, 3 recruiting

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053

    Cuibai Wei

    Not yet recruiting

  • Huashan Hospital, Fudan University

    Minhang District, 201107

    021-54601999

    Jintai Yu

    Not yet recruiting

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200127

    Gang Wang

    Not yet recruiting

Other trials in China

Japan2 sites, 2 recruiting

  • The University of Tokyo Hospital

    Bunkyō City, 113-8655

    81120023812

    Yoshiki Niimi

    Not yet recruiting

  • National Center for Geriatrics and Gerontology

    Ōbu, 4748511

    81120023812

    Keisuke Suzuki

    Not yet recruiting

Other trials in Japan

About this study

Official title: A Master Protocol for Phase 1 Clinical Trials of Multiple Amyloid-Targeting Therapies for the Treatment of Alzheimer's Disease

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).

Being tested
LY4405094, Placebo, Florbetapir F18, Florbetaben F 18
Medical subject headings
Alzheimer Disease, Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY4405094Drug

    Administered intravenously (IV)

  • LY4405094Drug

    Administered Subcutaneously (SC)

  • PlaceboDrug

    Administered IV

  • PlaceboDrug

    Administered SC

  • Florbetapir F18Other

    Administered IV

  • Florbetaben F 18Other

    Administered IV

Study groups in NCT07787169
Study groupRoleWhat they receive
LY4405094 Study AT01 (Healthy ISA)ExperimentalLY4405094 or placebo administered intravenously (IV) or subcutaneously (SC) in healthy volunteers.
Receives: Drug: LY4405094; Drug: Placebo
LY4405094 Study AT01 (AD ISA)ExperimentalLY4405094 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.
Receives: Drug: LY4405094; Drug: Placebo; Other: Florbetapir F18; Other: Florbetaben F 18

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of participants allocated to each substudy

    Measured: Baseline up to Day 160

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2026
  2. Study start9 Sep 2026
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
179 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07787169
Sponsor's protocol ID
27909
Other IDs
2026-527295-81-00, A1D-MC-ATMP, A1D-MC-AT01, A1D-MC-AT02
Status last verified
Oct 2026
First submitted
24 Aug 2026
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY4405094, Florbetapir F18 and Florbetaben F 18 in people with Alzheimer Disease and Amyloid, run by Eli Lilly and Company at 18 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, China, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of participants allocated to each substudy (time frame: Baseline up to Day 160). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07787169.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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