Clinical trial Recruiting at 3 sites Phase 1 Interventional Ages 18 to 85

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.

More Alzheimer Disease trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 85 Years
SexAll
Enrollment179 (estimated)
SponsorEli Lilly and Company
Industry-sponsored
Locations19 sites (Anaheim, California and 18 other locations)
StatusRecruiting
StartedSeptember 9, 2026
Main results expectedJuly 2028
Study endsJuly 2028
Registry record updatedNovember 5, 2026
Trial IDNCT07787169 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.