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

Part of paid clinical trials in Irvine, California.

Sponsor
Eli Lilly and Company
Study ID
NCT07787169
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • LY4405094 — DRUG
    Administered intravenously (IV)
  • LY4405094 — DRUG
    Administered Subcutaneously (SC)
  • Placebo — DRUG
    Administered IV
  • Placebo — DRUG
    Administered SC
  • Florbetapir F18 — OTHER
    Administered IV
  • Florbetaben F 18 — OTHER
    Administered IV

Study Details

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).

Key Dates

First listed
Aug 26, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
179 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: LY4405094 Study AT01 (Healthy ISA)
    LY4405094 or placebo administered intravenously (IV) or subcutaneously (SC) in healthy volunteers.
  • Experimental: LY4405094 Study AT01 (AD ISA)
    LY4405094 or placebo administered IV to participants with AD. Florbetapir F 18 or Florbetaben F 18 will be administered IV during amyloid positron emission tomography (PET) scan.

Primary Outcome Measure

The number of participants allocated to each substudy [ Time Frame: Baseline up to Day 160 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (10)

FacilityCityStateZIPSite coordinators
Irvine Clinical ResearchIrvineCalifornia92614
Elly Lee (PRINCIPAL_INVESTIGATOR)
Fortrea Clinical Research UnitDaytona BeachFlorida32117
386-366-6400
Chiamaka Iheme (PRINCIPAL_INVESTIGATOR)
K2 Medical Research - The VillagesLady LakeFlorida32159
Craig Curtis (PRINCIPAL_INVESTIGATOR)
K2 Medical ResearchMaitlandFlorida32751
Brandon Lenox (PRINCIPAL_INVESTIGATOR)
Charter ResearchOrlandoFlorida32803
Diana Balsalobre (PRINCIPAL_INVESTIGATOR)
Progressive Medical ResearchPort OrangeFlorida32127
Alexander White (PRINCIPAL_INVESTIGATOR)
K2 Medical Research - TampaTampaFlorida33634
Kelley Wilson (PRINCIPAL_INVESTIGATOR)
Charter ResearchThe VillagesFlorida32162-2698
Jeffrey Norton (PRINCIPAL_INVESTIGATOR)
Accel Research Sites - NeuroStudies Clinical Research UnitDecaturGeorgia30030
Marshall Nash (PRINCIPAL_INVESTIGATOR)
QUEST Research InstituteFarmington HillsMichigan48334
Aaron Ellenbogen (PRINCIPAL_INVESTIGATOR)

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Irvine Clinical Research· Irvine, CAFortrea Clinical Research Unit· Daytona Beach, FLK2 Medical Research - The Villages· Lady Lake, FLK2 Medical Research· Maitland, FLCharter Research· Orlando, FLProgressive Medical Research· Port Orange, FL

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