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| ID | Type | Description | Link |
|---|---|---|---|
| J5K-MC-OQAA | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4006895 of Part A (SAD) | Experimental | Single-ascending doses of LY4006895 administered intravenously (IV) |
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| Placebo Part A | Placebo Comparator | Placebo administered IV |
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| LY4006895 of Part B (MAD) | Experimental | Multiple-ascending doses of LY4006895 will be administered IV |
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| Placebo Part B | Placebo Comparator | Placebo administered IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4006895 | Drug | Administered IV |
| |
| 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) |
| 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 |
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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:
For Part B:
Have early symptomatic AD, as defined by:
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:
For Part B:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network - CNS | Recruiting | Los Alamitos | California | 90720 | United States |
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| Placebo |
| Drug |
Administered IV |
|
| Baseline to Study Completion (Up to 61 Weeks) |
| K2 Medical Research - The Villages | Recruiting | Lady Lake | Florida | 32159 | United States |
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| K2 Medical Research | Recruiting | Maitland | Florida | 32751 | United States |
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| Aqualane Clinical Research | Not yet recruiting | Naples | Florida | 34105 | United States |
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| Progressive Medical Research | Not yet recruiting | Port Orange | Florida | 32127 | United States |
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| K2 Medical Research - Tampa | Not yet recruiting | Tampa | Florida | 33634 | United States |
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| Atlanta Center of Medical Research | Recruiting | Atlanta | Georgia | 30331 | United States |
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| CenExel iResearch, LLC (CenExel iRA) | Recruiting | Decatur | Georgia | 30030 | United States |
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| QUEST Research Institute | Not yet recruiting | Farmington Hills | Michigan | 48334 | United States |
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| CenExel-HRI | Recruiting | Marlton | New Jersey | 08053 | United States |
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| Duke Early Phase Research Unit | Not yet recruiting | Durham | North Carolina | 27710 | United States |
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| The University of Tokyo Hospital | Not yet recruiting | Bunkyō City | 113-8654 | Japan |
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| National Center for Geriatrics and Gerontology | Not yet recruiting | Ōbu | 4748511 | Japan |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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