Recruiting
Phase 1

LY4006895

Sponsor:

Eli Lilly and Company

Code:

NCT06657768

Conditions

Alzheimer Disease

Healthy

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

LY4006895

Placebo

Study Details

Brief summary:

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.

Conditions

Alzheimer Disease

Healthy

Study ID

NCT06657768

Start date

Oct 29, 2024

Status verified date

Jun, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria for Part A and Part B:

\- Have a body mass index (BMI) within the range 18 to 40 kilogram per square meter (kg/m²)

For Part A:

  • Are overtly healthy as determined by medical evaluation. Rescreening is not allowed in this study

For Part B:

  • Have early symptomatic AD, as defined by:

  • Gradual and progressive change in memory function for at least 6 months, as reported by the participant or informant
  • A Mini-Mental State Exam (MMSE) score of 18 to 30 at screening
  • A Clinical Dementia Rating (CDR) global score of 0.5 to 1.0 (inclusive), with a memory box score greater than or equal to 0.5 at screening
  • Have up to 2 reliable study partners who are in frequent contact with the participant (defined as at least 10 hours per week), one of whom at any one occasion: will accompany the participant to the study visits, will be available by telephone at designated times, and will provide a separate written informed consent to participate

Exclusion Criteria for Part A and Part B:

  • Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, neurologic (MAD: other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the participant's ability to complete the study; or has a life expectancy of less than 24 months
  • Have screening hemoglobin (Hb) less than 12 grams per deciliter (g/dL) or evidence of iron-deficiency (ferritin less than 30 nanograms per milliliter (ng/mL), or presence/history of hemoglobinopathy
  • Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening that cannot be explained by regular concomitant medications
  • Have previous exposure to any anti-tau therapy
  • Are pregnant or intend to become pregnant or to breastfeed during the study

For Part B:

  • Have a current exposure to an amyloid targeted therapy. Prior exposure to amyloid targeted therapies greater than 1 year from the last dose may be permitted at the discretion of the investigator and in consultation with the sponsor. A listing of amyloid targeted therapies will be provided
  • Have a sensitivity to florataucipir 18F
  • Have contraindication to magnetic resonance imaging (MRI) including claustrophobia or the presence of contraindicated metal (ferrogmagnetic) implants/cardiac pacemaker

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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

Interventions

LY4006895

Administered IV

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 and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Collaborative Neuroscience Network - CNS

Recruiting

Los Alamitos, California, United States, 90720

Contacts

8667874257 or 5627427116

Principal Investigator:

Steven Reynolds

K2 Medical Research - The Villages

Recruiting

Lady Lake, Florida, United States, 32159

Contacts

321-278-5590

Principal Investigator:

Craig Curtis

K2 Medical Research

Recruiting

Maitland, Florida, United States, 32751

Contacts

407-500-5252

Principal Investigator:

Brandon Lenox

Atlanta Center of Medical Research

Recruiting

Atlanta, Georgia, United States, 30331

Contacts

404-881-5800

Principal Investigator:

Elyssa Barron

CenExel iResearch, LLC (CenExel iRA)

Recruiting

Decatur, Georgia, United States, 30030

Contacts

404-537-1281

Principal Investigator:

Kimball Johnson

CenExel-HRI

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

856-452-9901

Principal Investigator:

Elan Cohen

More Information

Sponsor

Eli Lilly and Company

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-06-04.