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| ID | Type | Description | Link |
|---|---|---|---|
| J1G-MC-LAKA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety and tolerability of LY3372993 in healthy participants and participants with AD. The study will also investigate how much LY3372993 gets into the bloodstream and test the effects of LY3372993 in participants with AD.
The study has two parts:
In April, 2019, Eli Lilly and Company made a business decision to terminate Part B. No participants were enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3372993 (Part A) | Experimental | LY3372993 administered intravenously (IV) to healthy participants. |
|
| Placebo (Part A) | Placebo Comparator | Placebo administered IV to healthy participants. |
|
| LY3372993 (Part B) | Experimental | LY3372993 administered IV to participants with AD. Part B was terminated before any participants received treatment. |
|
| Placebo (Part B) | Placebo Comparator | Placebo administered IV to participants with AD. Part B was terminated before any participants received treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3372993 | Drug | Administered IV. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to Day 562 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3372993 After a Single Dose | PK: AUC of LY3372993 After a Single Dose | Predose up to Day 85 |
| PK: Maximum Observed Concentration (Cmax) of LY3372993 After a Single Dose |
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Inclusion Criteria :
Part A:
Part B:
Exclusion Criteria:
Part A:
Part B:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 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 | Long Beach | California | 90806 | United States | ||
| Covance Clinical Research Inc |
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| Placebo |
| Drug |
Administered IV. |
|
PK: Cmax of LY3372993 After a Single Dose
| Predose up to Day 85 |
| PK: AUC of LY3372993 at Steady State after Multiple Doses | PK: AUC of LY3372993 at Steady State after Multiple Doses | Week 14 through Week 18 |
| PK: Cmax of LY3372993 at Steady State After Multiple Doses | PK: Cmax of LY3372993 at Steady State After Multiple Doses | Week 14 through Week 18 |
| Pharmacodynamics (PD): Change from Baseline in Amyloid Load | Amyloid load measured by florbetapir F18 positron emission tomography (PET) scan | Baseline, Week 28 |
| Daytona Beach |
| Florida |
| 32117 |
| United States |
| Avail Clinical Research LLC | DeLand | Florida | 32720 | United States |
| MD Clinical | Hallandale | Florida | 33009 | United States |
| BioClinica Inc | Orlando | Florida | 32806 | United States |
| IMIC, Inc. | Palmetto Bay | Florida | 33157 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| BioClinica Inc | The Villages | Florida | 32162 | United States |
| Atlanta Center of Medical Research | Atlanta | Georgia | 30331 | United States |
| Carolina Phase 1 Research (Wake M3) | Raleigh | North Carolina | 27612 | United States |
| PRA Health Sciences | Salt Lake City | Utah | 84124 | United States |
| 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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