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This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of R1450 in patients with mild to moderate Alzheimer Disease. Patients will be randomized to receive either R1450 or placebo by intravenous infusion for a total of 7 doses. The starting dose will be escalated in subsequent cohorts of patients in an adaptive manner, after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gantenerumab | Drug | Administered iv at escalating doses (7 cohorts) |
|
| Measure | Description | Time Frame |
|---|---|---|
| AEs, laboratory parameters, vital signs. | Throughout study | |
| Pharmacokinetic parameters of R1450 in plasma | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| CSF biomarkers, clinical efficacy parameters. | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen | 2100 | Denmark | ||||
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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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| Ramat Gan |
| 52621 |
| Israel |
| Amsterdam | 1081 GM | Netherlands |
| Malmö | 20502 | Sweden |
| Stockholm | 14186 | Sweden |
| Blackpool | FY20JH | United Kingdom |
| Glasgow | G20 0XA | United Kingdom |
| Southampton | SO30 3JB | United Kingdom |
| Swindon | SN3 6BW | United Kingdom |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |