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| ID | Type | Description | Link |
|---|---|---|---|
| J1G-MC-LAKB | 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 participants with AD, non-Japanese, and Japanese healthy participants who are of first-generation Japanese origin. The study will also investigate how much LY3372993 gets into the bloodstream and will test the effects of LY3372993. The study will be conducted in two parts. The part A includes participants with AD and part B includes healthy participants. Participation could last up to about 61 weeks and may include up to 31 visits to the study center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3372993 (Part A) | Experimental | LY3372993 administered as multiple doses either intravenously (IV) or subcutaneously (SC). |
|
| LY3372993 (Part B) | Experimental | LY3372993 administered as single dose IV or SC. |
|
| Placebo (Part A) | Placebo Comparator | Placebo administered as multiple doses IV or SC. |
|
| Placebo (Part B) | Placebo Comparator | Placebo administered as single dose IV or SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3372993 | Drug | Administered IV or SC. |
| |
| 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 through Week 61 (part A) and Week 13 (Part B) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3372993 | PK: Cmax of LY3372993 | Day 1 Predose through Week 61 (part A) and Week 13 (Part B) |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3372993 |
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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 |
|---|---|---|---|---|---|---|
| Altasciences Clinical Los Angeles, Inc | Cypress | California | 90630 | United States | ||
| Collaborative Neuroscience Research, LLC |
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| Label | URL |
|---|---|
| A Study of LY3372993 in Participants With Alzheimer's Disease (AD) | View source |
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| Placebo |
| Drug |
Administered IV or SC. |
|
PK: AUC of LY3372993
| Day 1 Predose through Week 61 (part A) and Week 13 (Part B) |
| Pharmacodynamics (PD): Change from Baseline in Cerebral Amyloid Plaque Level (Part A only) | PD: Cerebral amyloid plaque level measured using florbetapir positron emission tomography | Baseline and Week 61 (part A) |
| Long Beach |
| California |
| 90806 |
| United States |
| Accel Research Sites- Clinical Research Unit | DeLand | Florida | 32720 | United States |
| MD Clinical | Hallandale | Florida | 33009 | United States |
| IMIC, Inc. | Miami | Florida | 33176 | United States |
| Ppd Development | Orlando | Florida | 32806-1041 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Charter Research | The Villages | Florida | 32162 | United States |
| Synexus Clinical Research US, Inc. | The Villages | Florida | 32162 | United States |
| Covance Dallas | Dallas | Texas | 75247 | United States |
| Oita University Hospital | Yufu | Oita Prefecture | 879-5503 | Japan |
| The University of Tokyo Hospital | Bunkyo-ku | Tokyo | 113-8655 | Japan |
| Clinical Research Hospital Tokyo | Shinjuku-ku | Tokyo | 162-0053 | Japan |
| 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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