RecruitingPhase 1

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

Lead sponsor

Eli Lilly and Company

Asset

LY4006895

Listed sites

Recruiting sites

Enrollment

128

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•early symptomatic AD•CDR global 0.5-1•MMSE 18-30•MRI contraindications excluded

Primary endpoint

•Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID27263

Secondary IDJ5K-MC-OQAAEli Lilly and Company

NCT IDNCT06657768

Timeline

Milestones

Study first posted2024-10-24actual

Study start2024-10-29actual

Last update posted2026-06-04actual

Primary completion2027-07estimated (month precision)

Study completion2027-07estimated (month precision)

Assets

Drug assets

LY4006895

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age45 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

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)

event count, event

Secondary/protocol endpoint

PK: Maximum Concentration (Cmax) of LY4006895

Time frame:Baseline to Study Completion (Up to 61 Weeks)

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Baseline to Study Completion (Up to 61 Weeks)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.