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| ID | Type | Description | Link |
|---|---|---|---|
| H8A-JE-LZAK | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple dosing Solanezumab in subjects with mild-to-moderate AD in Japanese population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QW | Experimental | IV infusion of 400mg once each week for 2 months |
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| Q4W | Experimental | IV infusion of 400mg once every four weeks for 2 months |
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| Q8W | Experimental | IV infusion of 400mg once every eight weeks for 2 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solanezumab | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the extended ADAS-Cog stand for Alzheimer's Disease Assessment Scale-Cognitive subscale | 6 months | |
| pharmacodynamic of Aβ1-40 and Aβ1-42 | 6 months | |
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Inclusion Criteria:
Men or non-fertile women, at least 50 years of age.(Women who are not surgically sterilized must be post-menopausal for at least 1 year.)
Patients with mild to moderate AD by following disease diagnostic criteria
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ehime | 791-0295 |
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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 |
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| ID | Term |
|---|---|
| C550616 | solanezumab |
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| Pharmacokinetics |
| 6 months |
| Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hiroshima | 728-0001 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hyōgo | 672-8501 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kyoto | 616-8255 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Osaka | 530 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tokushima | 770-8503 | Japan |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |