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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-121849 | Registry Identifier | JAPIC |
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Objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamic effects of multiple doses of Gantenerumab in subject with mild to moderate AD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gantenerumab | Drug | 75 mg subcutaneous doses every 4 weeks for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | 36 weeks | |
| Pharmacokinetic parameters of Gantenerumab in plasma | 36 weeks | |
| CSF/plasma ratios of Gantenerumab. | Baseline, Day183 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in plasma Abeta | Baseline,Day183 | |
| Change from baseline in plasma and CSF tau | Baseline,Day183 | |
| Change from baseline in Mini-Mental State Examination (MMSE) and Alzheimer's disease assessment scale cognitive behaviors (ADAS-Cog). |
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Inclusion Criteria:
Exclusion Criteria:
etc.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansai region | Kansai | Japan | ||||
| Kanto region, |
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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 |
|---|---|
| C571128 | gantenerumab |
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| Gantenerumab |
| Drug |
105 mg subcutaneous doses every 4 weeks for 24 weeks |
|
| Gantenerumab | Drug | 225 mg subcutaneous doses every 4 weeks for 24 weeks |
|
| Placebo | Drug | subcutaneous doses every 4 weeks for 24 weeks |
|
| Baseline,Day85, 197, 253 |
| Kanto |
| Japan |
| Kyushu region | Kyushu | Japan |
| Tokai region | Toakai | Japan |
| Tohoku region | TÅhoku | Japan |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |