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This is a longitudinal, follow-up study in participants with Alzheimer's disease (AD) who previously participated in study BP29409 (NCT02187627). This study is designed to assess the longitudinal change of Tau pathology in the brain of participants with AD using the PET ligand [18F]RO6958948 and to assess the safety and tolerability of PET ligand.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]RO6958948 | Experimental | Each participant will receive a single intravenous (IV) dose of [18F]RO6958948 and a single PET scan approximately 9-24 months after the baseline scan (in Study BP29409). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]RO6958948 | Drug | Radiolabeled low molecular weight compound, administered as single IV injection. The mass dose of [18F]RO6958948 injected will be less than or equal to (\ |
| Measure | Description | Time Frame |
|---|---|---|
| Regional Standardized Uptake Value (SUV), as Assessed by the tau PET Brain Scan | Day 1 | |
| Regional Standardized Uptake Value Ratios (SUVR), as Assessed by the Tau PET Brain Scan | Day 1 | |
| Change in SUV for Different Brain Regions | Baseline to approximately 24 months | |
| Change in SUVR for Different Brain Regions | Baseline to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events | Screening to 7-14 days after Tau PET scan (Up to approximately 7 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for All Participants
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medical Institutions, Johns Hopkins Outpatient Center | Baltimore | Maryland | 21287-0807 | United States |
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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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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |