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

A Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, PK and PD of LY4006895 in Healthy Volunteers and Patients With Early Symptomatic AD

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Alzheimer Disease
• Intervention / Treatment: Drug: Placebo; Drug: LY4006895

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• Japan
  • Bunkyō City, Japan, 113-8654
    • Not yet recruiting
    • The University of Tokyo Hospital
    • Contact: Phone Number: 81120023812
    • Principal Investigator: Yoshiki Niimi
  • Ōbu, Japan, 4748511
    • Not yet recruiting
    • National Center for Geriatrics and Gerontology
    • Contact: Phone Number: 81120023812
    • Principal Investigator: Keisuke Suzuki
• United States
  • California
    • Los Alamitos, California, United States, 90720
      • Recruiting
      • Collaborative Neuroscience Network - CNS
      • Principal Investigator: Steven Reynolds
      • Contact: Phone Number: 8667874257 or 5627427116
  • Florida
    • Lady Lake, Florida, United States, 32159
      • Recruiting
      • K2 Medical Research - The Villages
      • Principal Investigator: Craig Curtis
      • Contact: Phone Number: 321-278-5590
    • Maitland, Florida, United States, 32751
      • Recruiting
      • K2 Medical Research
      • Contact: Phone Number: 407-500-5252
      • Principal Investigator: Brandon Lenox
    • Naples, Florida, United States, 34105
      • Not yet recruiting
      • Aqualane Clinical Research
      • Principal Investigator: William Justiz
      • Contact: Phone Number: 239-529-6780
    • Port Orange, Florida, United States, 32127
      • Not yet recruiting
      • Progressive Medical Research
      • Contact: Phone Number: 386-304-7070
      • Principal Investigator: Alexander White
    • Tampa, Florida, United States, 33634
      • Not yet recruiting
      • K2 Medical Research - Tampa
      • Contact: Phone Number: 813-800-5252
      • Principal Investigator: Kelley Wilson
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Recruiting
      • Atlanta Center of Medical Research
      • Contact: Phone Number: 404-881-5800
      • Principal Investigator: Elyssa Barron
    • Decatur, Georgia, United States, 30030
      • Recruiting
      • CenExel iResearch, LLC (CenExel iRA)
      • Contact: Phone Number: 404-537-1281
      • Principal Investigator: Kimball Johnson
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Not yet recruiting
      • QUEST Research Institute
      • Contact: Phone Number: 248-957-8940
      • Principal Investigator: Aaron Ellenbogen
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Recruiting
      • CenExel-HRI
      • Principal Investigator: Elan Cohen
      • Contact: Phone Number: 856-452-9901
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Not yet recruiting
      • Duke Early Phase Research Unit
      • Principal Investigator: Shruti Raja
      • Contact: Phone Number: 919-684-5196

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY4006895 of Part A (SAD); Single-ascending doses of LY4006895 administered intravenously (IV)	Drug: LY4006895; Administered IV
Placebo Comparator: Placebo Part A; Placebo administered IV	Drug: Placebo; Administered IV
Experimental: LY4006895 of Part B (MAD); Multiple-ascending doses of LY4006895 will be administered IV	Drug: LY4006895; Administered IV
Placebo Comparator: Placebo Part B; Placebo administered IV	Drug: Placebo; Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK: Maximum Concentration (Cmax) of LY4006895	PK: Cmax of LY4006895	Baseline to Study Completion (Up to 61 Weeks)
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4006895	PK: AUC of LY4006895	Baseline to Study Completion (Up to 61 Weeks)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): October 29, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 27263; J5K-MC-OQAA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No