Ireland
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Recruiting Phase 1

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

NCT07787169 · tracked via the Priya Life Science Japan tracker
Phase
Phase 1
Started
2026-09-09
Last updated
2026-10-08

Condition(s) studied

Alzheimer DiseaseAmyloidPlaque, AmyloidHealthy Volunteers

Investigational drug(s) / intervention(s)

LY4405094 →LY4405094 →PlaceboPlaceboFlorbetapir F18Florbetaben F 18

LY4405094: Administered intravenously (IV)

LY4405094: Administered Subcutaneously (SC)

Placebo: Administered IV

Placebo: Administered SC

Florbetapir F18: Administered IV

Florbetaben F 18: Administered IV

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
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.

Primary outcome measure(s)

  • The number of participants allocated to each substudy — Baseline up to Day 160

Trial sites (18)

FacilityCityRegionStatus
CenExel ACT Anaheim California Not Yet Recruiting
Irvine Clinical Research Irvine California Not Yet Recruiting
Collaborative Neuroscience Network - CNS Los Alamitos California Not Yet Recruiting
Fortrea Clinical Research Unit Daytona Beach Florida Recruiting
K2 Medical Research - The Villages Lady Lake Florida Not Yet Recruiting
K2 Medical Research Maitland Florida Not Yet Recruiting
Charter Research Orlando Florida Not Yet Recruiting
Progressive Medical Research Port Orange Florida Not Yet Recruiting
Alzheimer's Research and Treatment Center Stuart Florida Not Yet Recruiting
K2 Medical Research - Tampa Tampa Florida Not Yet Recruiting
Charter Research The Villages Florida Not Yet Recruiting
Accel Research Sites - NeuroStudies Clinical Research Unit Decatur Georgia Not Yet Recruiting
QUEST Research Institute Farmington Hills Michigan Not Yet Recruiting
Xuanwu Hospital Capital Medical University Beijing China Not Yet Recruiting
Huashan Hospital, Fudan University Minhang District China Not Yet Recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai China Not Yet Recruiting
The University of Tokyo Hospital Bunkyō City Japan Not Yet Recruiting
National Center for Geriatrics and Gerontology Ōbu Japan Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07787169 on ClinicalTrials.gov ↗ ← All trials in Japan