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
- Diseases
- Alzheimer disease
- 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
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Tokyo Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Not yet recruiting |
| National Center for Geriatrics and Gerontology Coordinator of this site? Confirm its status | Ōbu | Japan | Not yet recruiting |
| Atlanta Center of Medical Research Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| CenExel iResearch, LLC (CenExel iRA) Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Duke Early Phase Research Unit Coordinator of this site? Confirm its status | Durham | United States | Not yet recruiting |
| QUEST Research Institute Coordinator of this site? Confirm its status | Farmington Hills | United States | Not yet recruiting |
| K2 MEDICAL Research THE VILLAGES Coordinator of this site? Confirm its status | Lady Lake | United States | Recruiting |
| Collaborative Neuroscience Network - CNS Coordinator of this site? Confirm its status | Los Alamitos | United States | Recruiting |
| K2 Medical Research Coordinator of this site? Confirm its status | Maitland | United States | Recruiting |
| CenExel-HRI Coordinator of this site? Confirm its status | Marlton | United States | Recruiting |
| Aqualane Clinical Research Coordinator of this site? Confirm its status | Naples | United States | Not yet recruiting |
| Progressive Medical Research Coordinator of this site? Confirm its status | Port Orange | United States | Not yet recruiting |
| K2 Medical Research - Tampa Coordinator of this site? Confirm its status | Tampa | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.