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

Eli Lilly and Company

Summary

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 or A1D-MC-AT02 (upcoming).

Eligibility

Age range: 18–85 years
Sex: All
Healthy volunteers: Yes

Detailed 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 funct…

Interventions

Drug
LY4405094
Administered intravenously (IV)
Drug
LY4405094
Administered Subcutaneously (SC)
Drug
Placebo
Administered IV
Drug
Placebo
Administered SC
Other
Florbetapir F18
Administered IV
Other
Florbetaben F 18
Administered IV

Locations (10)

Irvine Clinical Research
Irvine, California
Fortrea Clinical Research Unit
Daytona Beach, Florida
386-366-6400
K2 Medical Research - The Villages
Lady Lake, Florida
K2 Medical Research
Maitland, Florida
Charter Research
Orlando, Florida
Progressive Medical Research
Port Orange, Florida