Evaluating LY4006895 in Healthy Individuals and Those with Early Alzheimer's Disease
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
This study is testing a new drug called LY4006895 to see if it's safe for healthy people and those with early Alzheimer's disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 9 sites (Los Alamitos, California and 8 other locations) |
| Trial ID | NCT06657768 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of the drug LY4006895 in two parts: one involving healthy participants and the other involving individuals with early symptomatic Alzheimer's Disease (AD). In Part A, a single-ascending dose will be administered to healthy participants, while Part B will involve multiple-ascending doses for those with early AD. Blood tests will be conducted to measure the drug's absorption and elimination from the body. The overall duration of the study is approximately 29 weeks for Part A and 61 weeks for Part B, including screening periods.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals and those with early symptomatic Alzheimer's Disease who meet specific cognitive and health criteria.
Not a fit: Patients with advanced Alzheimer's Disease or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for individuals with early symptomatic Alzheimer's Disease.
How similar studies have performed: Other studies have explored similar drug mechanisms in Alzheimer's Disease, but the specific approach of LY4006895 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Alamitos, California and 8 other locations
- Collaborative Neuroscience Network - CNS — Los Alamitos, California, United States (Recruiting)
- K2 Medical Research - The Villages — Lady Lake, Florida, United States (Recruiting)
- K2 Medical Research — Maitland, Florida, United States (Recruiting)
- Atlanta Center of Medical Research — Atlanta, Georgia, United States (Recruiting)
- CenExel iResearch, LLC (CenExel iRA) — Decatur, Georgia, United States (Recruiting)
- CenExel-HRI — Marlton, New Jersey, United States (Recruiting)
- Duke Early Phase Research Unit — Durham, North Carolina, United States (Not_yet_recruiting)
- The University of Tokyo Hospital — Bunkyō City, Japan (Not_yet_recruiting)
- National Center for Geriatrics and Gerontology — Ōbu, Japan (Not_yet_recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.