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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorEli Lilly and Company

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4405094

    Drug

    Administered intravenously (IV)

  • LY4405094

    Drug

    Administered Subcutaneously (SC)

  • Placebo

    Drug

    Administered IV

  • Placebo

    Drug

    Administered SC

  • Florbetapir F18

    Other intervention

    Administered IV

  • Florbetaben F 18

    Other intervention

    Administered IV

Treatment groups

179 Participants
are divided into 2 treatment groups
Group A: LY4405094 Study AT01 (Healthy ISA)Experimental treatment 2 interventions
Group B: LY4405094 Study AT01 (AD ISA)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

The number of participants allocated to each substudy

Time frame
Baseline up to Day 160

Secondary outcomes

Other outcomes

Sponsors and contacts

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