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

NCT06657768 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27263J5K-MC-OQAA
• Study Type: interventional
• Target: 128
• Locations: 2 countries
• Sites: 9

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

Healthy; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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

  A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module

  Baseline to Study Completion (Up to 61 Weeks)

Secondary Outcomes (2)

• PK: Maximum Concentration (Cmax) of LY4006895

  Baseline to Study Completion (Up to 61 Weeks)

• PK: Area Under the Concentration Versus Time Curve (AUC) of LY4006895

  Baseline to Study Completion (Up to 61 Weeks)

Study Arms (4)

LY4006895 of Part A (SAD)

EXPERIMENTAL

Single-ascending doses of LY4006895 administered intravenously (IV)

Drug: LY4006895

Placebo Part A

PLACEBO COMPARATOR

Placebo administered IV

Drug: Placebo

LY4006895 of Part B (MAD)

EXPERIMENTAL

Multiple-ascending doses of LY4006895 will be administered IV

Drug: LY4006895

Placebo Part B

PLACEBO COMPARATOR

Placebo administered IV

Drug: Placebo

Interventions

LY4006895 DRUG

Administered IV

LY4006895 of Part A (SAD); LY4006895 of Part B (MAD)

Placebo DRUG

Administered IV

Placebo Part A; Placebo Part B

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (9)

Collaborative Neuroscience Network - CNS

Los Alamitos, California, 90720, United States

RECRUITING

K2 Medical Research - The Villages

Lady Lake, Florida, 32159, United States

RECRUITING

K2 Medical Research

Maitland, Florida, 32751, United States

RECRUITING

Atlanta Center of Medical Research

Atlanta, Georgia, 30331, United States

RECRUITING

CenExel iResearch, LLC (CenExel iRA)

Decatur, Georgia, 30030, United States

RECRUITING

CenExel-HRI

Marlton, New Jersey, 08053, United States

RECRUITING

Duke Early Phase Research Unit

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

The University of Tokyo Hospital

Bunkyō City, 113-8654, Japan

NOT YET RECRUITING

National Center for Geriatrics and Gerontology

Ōbu, 4748511, Japan

NOT YET RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Call 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

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

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

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: October 29, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2); US (7)