Fact CheckerSign in

NCT07787169RecruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
179 (estimated)
First submitted
24 Aug 2026
Start date
9 Sept 2026
Primary completion date
31 Jul 2028
Lead sponsor
Eli Lilly and Company
NCT number
NCT07787169

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 179
  • From 9 Sept 2026 to the primary completion date, 31 Jul 2028
  • 18 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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 an abnormal blood pressure, pulse rate, or both, as determined by the investigator, or a preexisting history of hypertension.
  • 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 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.

Age

  • Have a family history of early onset AD (AD diagnosed before 65 years of age).

Other

  • Are pregnant or breastfeeding or intend to become pregnant or to breastfeed during the study;
  • 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.
  • Contraindications or unable to tolerate MRI
  • Contraindications to amyloid PET scan.

Who the study is looking for

  • 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).
  • 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.

Criteria the registry did not label

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

Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Xuanwu Hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaNot yet recruiting
Huashan Hospital, Fudan University
Coordinator of this site? Confirm its status
Minhang DistrictChinaNot yet recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaNot yet recruiting
The University of Tokyo Hospital
Coordinator of this site? Confirm its status
Bunkyō CityJapanNot yet recruiting
National Center for Geriatrics and Gerontology
Coordinator of this site? Confirm its status
ŌbuJapanNot yet recruiting
CenExel ACT
Coordinator of this site? Confirm its status
AnaheimUnited StatesNot yet recruiting
Fortrea Clinical Research Unit
Coordinator of this site? Confirm its status
Daytona BeachUnited StatesRecruiting
Accel Research Sites - NeuroStudies Clinical Research Unit
Coordinator of this site? Confirm its status
DecaturUnited StatesNot yet recruiting
QUEST Research Institute
Coordinator of this site? Confirm its status
Farmington HillsUnited StatesNot yet recruiting
Irvine Clinical Research
Coordinator of this site? Confirm its status
IrvineUnited StatesNot yet recruiting
K2 MEDICAL Research THE VILLAGES
Coordinator of this site? Confirm its status
Lady LakeUnited StatesNot yet recruiting
Collaborative Neuroscience Network - CNS
Coordinator of this site? Confirm its status
Los AlamitosUnited StatesNot yet recruiting
K2 Medical Research
Coordinator of this site? Confirm its status
MaitlandUnited StatesNot yet recruiting
Charter Research
Coordinator of this site? Confirm its status
OrlandoUnited StatesNot yet recruiting
Progressive Medical Research
Coordinator of this site? Confirm its status
Port OrangeUnited StatesNot yet recruiting
Alzheimer's Research and Treatment Center
Coordinator of this site? Confirm its status
StuartUnited StatesNot yet recruiting
K2 Medical Research - Tampa
Coordinator of this site? Confirm its status
TampaUnited StatesNot yet recruiting
Charter Research
Coordinator of this site? Confirm its status
The VillagesUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.