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
- Diseases
- Alzheimer disease
- 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
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Minhang District | China | Not yet recruiting |
| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| The University of Tokyo Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Not yet recruiting |
| National Center for Geriatrics and Gerontology Coordinator of this site? Confirm its status | Ōbu | Japan | Not yet recruiting |
| CenExel ACT Coordinator of this site? Confirm its status | Anaheim | United States | Not yet recruiting |
| Fortrea Clinical Research Unit Coordinator of this site? Confirm its status | Daytona Beach | United States | Recruiting |
| Accel Research Sites - NeuroStudies Clinical Research Unit Coordinator of this site? Confirm its status | Decatur | United States | Not yet recruiting |
| QUEST Research Institute Coordinator of this site? Confirm its status | Farmington Hills | United States | Not yet recruiting |
| Irvine Clinical Research Coordinator of this site? Confirm its status | Irvine | United States | Not yet recruiting |
| K2 MEDICAL Research THE VILLAGES Coordinator of this site? Confirm its status | Lady Lake | United States | Not yet recruiting |
| Collaborative Neuroscience Network - CNS Coordinator of this site? Confirm its status | Los Alamitos | United States | Not yet recruiting |
| K2 Medical Research Coordinator of this site? Confirm its status | Maitland | United States | Not yet recruiting |
| Charter Research Coordinator of this site? Confirm its status | Orlando | United States | Not yet recruiting |
| Progressive Medical Research Coordinator of this site? Confirm its status | Port Orange | United States | Not yet recruiting |
| Alzheimer's Research and Treatment Center Coordinator of this site? Confirm its status | Stuart | United States | Not yet recruiting |
| K2 Medical Research - Tampa Coordinator of this site? Confirm its status | Tampa | United States | Not yet recruiting |
| Charter Research Coordinator of this site? Confirm its status | The Villages | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.