A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease

Part of paid clinical trials in Maitland, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT06297590
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • LY3954068 — DRUG
    Administered IT
  • Placebo — DRUG
    Administered IT
  • Flortaucipir F18 — DRUG
    Administered intravenously (IV) prior to Positron Emission Tomography (PET) scan

Study Details

The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD). The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD. The study will be comprised of two parts, A and B. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. Each participant in Part B will receive 2 doses of either LY3954068 or placebo administered into the spinal fluid. Participants will have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068. The study will last up to approximately 45 weeks for Part A, and 100 weeks for Part B, including the screening period.

Key Dates

Start date
Aug 15, 2024
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: LY3954068 (Part A)
    Single ascending dose of LY3954068 administered intrathecally (IT)
  • Placebo Comparator: Placebo (Part A)
    Single ascending dose of placebo administered IT
  • Experimental: LY3954068 (Part B)
    Multiple ascending dose of LY3954068 administered IT
  • Placebo Comparator: Placebo (Part B)
    Multiple ascending dose of placebo administered IT

Primary Outcome Measure

Part A: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration [ Time Frame: Baseline up to Week 24 and Week 72 (for optional bridging period participants) ]

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 (6)

FacilityCityStateZIPSite coordinators
K2 Medical Research, LLCMaitlandFlorida32751
407-500-5252
Brandon Lenox (PRINCIPAL_INVESTIGATOR)
Charter Research, LLCThe VillagesFlorida32162
352-775-1000
Jeffrey Norton (PRINCIPAL_INVESTIGATOR)
CenExel iResearch, LLC (CenExel iRA)DecaturGeorgia30030
404-537-1281
Kimball Johnson (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital (MGH)CharlestownMassachusetts02129
617-643-5607
Steven Arnold (PRINCIPAL_INVESTIGATOR)
CenExel AMRIToms RiverNew Jersey08755
732-341-9500
Arun Singh (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27710
919-684-5196
Shruti Raja (PRINCIPAL_INVESTIGATOR)

Find similar trials in Maitland, FL

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
K2 Medical Research, LLC· Maitland, FLCharter Research, LLC· The Villages, FLCenExel iResearch, LLC (CenExel iRA)· Decatur, GAMassachusetts General Hospital (MGH)· Charlestown, MACenExel AMRI· Toms River, NJDuke University· Durham, NC

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