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NCT06657768RecruitingPhase 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

Source: ClinicalTrials.gov · Last updated 4 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
128 (estimated)
First submitted
23 Oct 2024
Start date
29 Oct 2024
Primary completion date
Jul 2027
Lead sponsor
Eli Lilly and Company
NCT number
NCT06657768

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 128
  • From 29 Oct 2024 to the primary completion date, Jul 2027
  • 13 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • 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 contraindication to magnetic resonance imaging (MRI) including claustrophobia or the presence of contraindicated metal (ferrogmagnetic) implants/cardiac pacemaker

Lab values

  • 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

Other

  • Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide
  • Are pregnant or intend to become pregnant or to breastfeed during the study
    • For Part B:
  • Have a sensitivity to florataucipir 18F

Who the study is looking for

  • \- 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

Age in the registry: 45 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The University of Tokyo Hospital
Coordinator of this site? Confirm its status
Bunkyō CityJapanNot yet recruiting
National Center for Geriatrics and Gerontology
Coordinator of this site? Confirm its status
ŌbuJapanNot yet recruiting
Atlanta Center of Medical Research
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
CenExel iResearch, LLC (CenExel iRA)
Coordinator of this site? Confirm its status
DecaturUnited StatesRecruiting
Duke Early Phase Research Unit
Coordinator of this site? Confirm its status
DurhamUnited StatesNot yet recruiting
QUEST Research Institute
Coordinator of this site? Confirm its status
Farmington HillsUnited StatesNot yet recruiting
K2 MEDICAL Research THE VILLAGES
Coordinator of this site? Confirm its status
Lady LakeUnited StatesRecruiting
Collaborative Neuroscience Network - CNS
Coordinator of this site? Confirm its status
Los AlamitosUnited StatesRecruiting
K2 Medical Research
Coordinator of this site? Confirm its status
MaitlandUnited StatesRecruiting
CenExel-HRI
Coordinator of this site? Confirm its status
MarltonUnited StatesRecruiting
Aqualane Clinical Research
Coordinator of this site? Confirm its status
NaplesUnited StatesNot yet recruiting
Progressive Medical Research
Coordinator of this site? Confirm its status
Port OrangeUnited StatesNot yet recruiting
K2 Medical Research - Tampa
Coordinator of this site? Confirm its status
TampaUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.