Healthy Volunteers, Alzheimer Disease, Amyloid, Plaque, Amyloid
Conditions
Brief summary
The purpose of this study is to see how safe LY4405094 is and to see how much and how quickly LY4405094 gets into the bloodstream. For healthy participants, the study also looks at how much LY4405094 gets into the fluid around the brain and lasts up to 13 weeks and will include a 4-day stay in the Clinical Research Unit (CRU). For participants with Alzheimer's Disease, the study will also look at levels of a specific Alzheimer's-related protein in the brain and will last up to 25 weeks and will include a 3-day stay in the CRU.
Interventions
DRUGLY4405094
Administered intravenously (IV)
DRUGPlacebo
Administered IV
OTHERFlorbetapir F18
Administered IV
OTHERFlorbetaben F 18
Administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must meet eligibility criteria in the ATMP screening protocol before entry into the treatment study.
Exclusion criteria
* Have known allergies to LY4405094, related compounds (including remternetug), or any components of the formulation, including LY4405094. * Have known allergic reactions to adhesive or hydrogels or a family history of adhesive skin allergies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline up to 25 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4405094 in Healthy Participants | Baseline through Study Completion (Week 13) |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY4405094 in Participants with Alzheimer's Disease (AD) | Baseline through Study Completion (25 Weeks) |
| Change from Baseline of Cerebrospinal Fluid (CSF) Concentration of LY4405094 in Healthy Participants | Baseline through Study Completion (Week 13) |
| Change from Baseline of Amyloid Plaque levels as Assessed by Amyloid Positron Emission Tomography (PET) in Participants with AD | Baseline through Study Completion (25 Weeks) |
Countries
United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed