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This open-label, multiple dose, parallel group study will assess the monoamine oxidase in the brain by in vivo positron emission tomography (PET) and safety of RO4602522 in patients with Alzheimer disease and in healthy volunteers. Patients and volunteers will receive multiple doses of RO4602522 and up to three injections of C11-L-deprenyl-D2 used in the PET.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO4602522 Group 1 | Experimental |
| |
| RO4602522 Group 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 11C-L-deprenyl-D2 | Drug | Intravenous injection of 11C-L-deprenyl-D2 before positron emission tomography (PET); up to 3 injections in total |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in monoamine oxidase (MAO-B) enzyme activity as measured by in vivo positron emission tomography (PET) | Days 1, 14, and between days 15 and 34 | |
| Pharmacokinetics: Plasma concentration of RO4602522 | Days 1, 8, 14, and between Days 15 and 34 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of 11C-L-deprenyl-D2 tracer uptake by in vivo positron emission tomography (PET) | Days 1, 14, and between days 15 and 34 | |
| Safety: incidence of adverse events | 35 days |
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Inclusion Criteria:
General:
Healthy volunteers:
Alzheimer Disease (AD) patients:
Exclusion Criteria:
General:
Healthy volunteers:
AD Patients:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stockholm | 141 86 | Sweden |
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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 |
|---|---|
| C000614721 | sembragiline |
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| RO4602522 | Drug | Multiple doses of RO4602522 for 14 days |
|
| RO4602522 | Drug | Multiple doses of RO4602522 for up to 17 days |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |