A Study of LY4006895 in Healthy Participants With Early Symptomatic Alzheimer's Disease (AD)

Part of paid clinical trials in Los Alamitos, California.

Sponsor
Eli Lilly and Company
Study ID
NCT06657768
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • LY4006895 — DRUG
    Administered IV
  • Placebo — DRUG
    Administered IV

Study Details

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY4006895. Part A will administer a single-ascending dose in healthy participants or Part B will administer multiple-ascending doses in participants with early symptomatic Alzheimer's Disease (AD). Blood tests will be performed to check how much LY4006895 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and will last approximately 29 weeks for Part A and 61 weeks for Part B, including a screening period for each part.

Key Dates

Start date
Oct 29, 2024
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

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

Arms

  • Experimental: LY4006895 of Part A (SAD)
    Single-ascending doses of LY4006895 administered intravenously (IV)
  • Placebo Comparator: Placebo Part A
    Placebo administered IV
  • Experimental: LY4006895 of Part B (MAD)
    Multiple-ascending doses of LY4006895 will be administered IV
  • Placebo Comparator: Placebo Part B
    Placebo administered IV

Primary Outcome Measure

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Discontinuations due to Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline to Study Completion (Up to 61 Weeks) ]

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 (11)

FacilityCityStateZIPSite coordinators
Collaborative Neuroscience Network - CNSLos AlamitosCalifornia90720
8667874257 or 5627427116
Steven Reynolds (PRINCIPAL_INVESTIGATOR)
K2 Medical Research - The VillagesLady LakeFlorida32159
321-278-5590
Craig Curtis (PRINCIPAL_INVESTIGATOR)
K2 Medical ResearchMaitlandFlorida32751
407-500-5252
Brandon Lenox (PRINCIPAL_INVESTIGATOR)
Aqualane Clinical ResearchNaplesFlorida34105
239-529-6780
William Justiz (PRINCIPAL_INVESTIGATOR)
Progressive Medical ResearchPort OrangeFlorida32127
386-304-7070
Alexander White (PRINCIPAL_INVESTIGATOR)
K2 Medical Research - TampaTampaFlorida33634
813-800-5252
Kelley Wilson (PRINCIPAL_INVESTIGATOR)
Atlanta Center of Medical ResearchAtlantaGeorgia30331
404-881-5800
Elyssa Barron (PRINCIPAL_INVESTIGATOR)
CenExel iResearch, LLC (CenExel iRA)DecaturGeorgia30030
404-537-1281
Kimball Johnson (PRINCIPAL_INVESTIGATOR)
QUEST Research InstituteFarmington HillsMichigan48334
248-957-8940
Aaron Ellenbogen (PRINCIPAL_INVESTIGATOR)
CenExel-HRIMarltonNew Jersey08053
856-452-9901
Elan Cohen (PRINCIPAL_INVESTIGATOR)
Duke Early Phase Research UnitDurhamNorth Carolina27710
919-684-5196
Shruti Raja (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Alamitos, CA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Collaborative Neuroscience Network - CNS· Los Alamitos, CAK2 Medical Research - The Villages· Lady Lake, FLK2 Medical Research· Maitland, FLAqualane Clinical Research· Naples, FLProgressive Medical Research· Port Orange, FLK2 Medical Research - Tampa· Tampa, FL

Related Studies