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

NCT ID
NCT07787169
Registry status
Not yet recruiting
Study type
Interventional
Phase
Phase 1
Sponsor
Eli Lilly and Company
Conditions
Alzheimer Disease, Amyloid, Healthy Volunteers, Plaque, Amyloid

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

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

Enrollment: 179 participants (Estimated).

What is being studied

  • Intervention: 4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene
  • Other: Florbetaben F 18
  • Intervention: florbetapir
  • Other: Florbetapir F18
  • Drug: LY4405094
  • Drug: Placebo

Who may be eligible

Ages
18 Years to 85 Years
Sex
All
Healthy volunteers accepted
Yes

ClinicalTrials.gov lists the following 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 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 locations

16 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: China, Japan, United States

  • California, United States: 3
  • Florida, United States: 8
  • Georgia, United States: 1
  • Michigan, United States: 1

Sample of listed locations

  • Xuanwu Hospital Capital Medical University — Beijing, 100053, China — Site recruitment status not specified in the registry data
  • The University of Tokyo Hospital — Bunkyō City, 113-8655, Japan — Site recruitment status not specified in the registry data
  • National Center for Geriatrics and Gerontology — Ōbu, 4748511, Japan — Site recruitment status not specified in the registry data
  • CenExel ACT — Anaheim, California, 92801, United States — Site recruitment status not specified in the registry data
  • Irvine Clinical Research — Irvine, California, 92614, United States — Site recruitment status not specified in the registry data
  • Collaborative Neuroscience Network - CNS — Los Alamitos, California, 90720, United States — Site recruitment status not specified in the registry data
  • Fortrea Clinical Research Unit — Daytona Beach, Florida, 32117, United States — Site recruitment status not specified in the registry data
  • K2 Medical Research - The Villages — Lady Lake, Florida, 32159, United States — Site recruitment status not specified in the registry data
  • K2 Medical Research — Maitland, Florida, 32751, United States — Site recruitment status not specified in the registry data
  • Charter Research — Orlando, Florida, 32803, United States — Site recruitment status not specified in the registry data
  • Progressive Medical Research — Port Orange, Florida, 32127, United States — Site recruitment status not specified in the registry data
  • Alzheimer's Research and Treatment Center — Stuart, Florida, 34996, United States — Site recruitment status not specified in the registry data
  • K2 Medical Research - Tampa — Tampa, Florida, 33634, United States — Site recruitment status not specified in the registry data
  • Charter Research — The Villages, Florida, 32162-2698, United States — Site recruitment status not specified in the registry data
  • Accel Research Sites - NeuroStudies Clinical Research Unit — Decatur, Georgia, 30030, United States — Site recruitment status not specified in the registry data
  • QUEST Research Institute — Farmington Hills, Michigan, 48334, United States — Site recruitment status not specified in the registry data

Study details

Start date
September 1, 2026
Primary completion date
July 1, 2028
Completion date
July 1, 2028
First posted
August 26, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07787169
Registry last updated
September 22, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07787169 on ClinicalTrials.gov

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