Test of amyloid-targeting medicines in healthy people and adults with Alzheimer’s
Official title: A Master Protocol for Phase 1 Clinical Trials of Multiple Amyloid-Targeting Therapies for the Treatment of Alzheimer's Disease
Run by Eli Lilly and Company · NCT07787169 · Data updated 2026-11-12
This trial tests the safety and tolerability of amyloid-targeting drugs, plus a placebo, in healthy adults and in people with Alzheimer’s disease to see if the drugs can reduce brain amyloid plaques.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 179 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 19 sites (Anaheim, California and 18 other locations) |
| Status | Recruiting |
| Started | September 9, 2026 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07787169 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults 18-45 without significant medical issues, and adults 55-85 with mild cognitive impairment or mild-to-moderate Alzheimer's disease who have a positive amyloid PET scan and meet study-specific criteria.
✕Probably not a fit
Participants who do not have an amyloid-positive PET or who experience adverse safety events may not benefit from treatment effects.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 master protocol evaluating multiple amyloid-targeting therapies. Participants include healthy volunteers aged 18-45 and adults with Alzheimer's disease aged 55-85, with substudies focusing on safety, tolerability, and potential plaque reduction. The study uses biomarkers and imaging to assess amyloid burden, and randomizes participants to active treatment or placebo. Enrollment will occur through two substudies, A1D-MC-AT01 and A1D-MC-AT02, at sites in California. The sponsor is Eli Lilly, with participating centers in Anaheim, Irvine, and Los Alamitos.
Why it matters
Potential benefit: If successful, participants could gain access to novel therapies that may reduce brain amyloid plaques and improve biomarker profiles.
How similar studies have gone: Previous studies of amyloid-targeting approaches have shown mixed results; this master protocol seeks to clarify safety and potential plaque reduction in a controlled setting.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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CenExel ACT
Anaheim, California, United States Recruiting -
Collaborative Neuroscience Network - CNS
Los Alamitos, California, United States Recruiting -
Fortrea Clinical Research Unit
Daytona Beach, Florida, United States Recruiting -
Irvine Clinical Research
Irvine, California, United States Not yet recruiting -
K2 Medical Research - The Villages
Lady Lake, Florida, United States Not yet recruiting -
K2 Medical Research
Maitland, Florida, United States Not yet recruiting
Show 13 more locations
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Charter Research
Orlando, Florida, United States Not yet recruiting -
Progressive Medical Research
Port Orange, Florida, United States Not yet recruiting -
Alzheimer's Research and Treatment Center
Stuart, Florida, United States Not yet recruiting -
K2 Medical Research - Tampa
Tampa, Florida, United States Not yet recruiting -
Charter Research
The Villages, Florida, United States Not yet recruiting -
Accel Research Sites - NeuroStudies Clinical Research Unit
Decatur, Georgia, United States Not yet recruiting -
QUEST Research Institute
Farmington Hills, Michigan, United States Not yet recruiting -
Xuanwu Hospital Capital Medical University
Beijing, China Not yet recruiting -
Peking University Third Hospital
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
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.