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This study is designed to obtain basic information on three PET imaging tracers developed to detect tau pathology in the brain. In this study, healthy control participants and participants with AD will be studied. Information collected will include brain and plasma kinetics, tissue distribution (in the brain), radiation dosimetry, and test-retest variability of the signal in the brain. The study will consist of Part 1, Part 2A, and Part 2B. During Part 1, imaging data will be assessed on an ongoing basis and based on data, one tracer will be prioritized over the other two tracers. The tracer selected will be further investigated in Part 2A and Part 2B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Tracer Selection | Experimental | Participants will receive a single dose of one tracer on one occasion and a single dose of a different tracer after 7 to 14 days and will be followed for 7 to 14 days for safety. At the end of Part 1, one tracer with the best performance will be selected for further study in Part 2. |
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| Part 2A: Test-Retest | Experimental | Participants will receive a single dose of selected tracer from Part 1 on one occasion and then same tracer will be administered after 6 weeks. Participants will be followed for 7 to 14 days after last PET tracer administration for safety. |
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| Part 2B: Dosimetry | Experimental | Participants will receive a single dose of selected tracer from Part 1 and will be followed for 7 to 14 days for evaluation of radiation dosimetry. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [11C]RO6924963 | Drug | Radiolabeled low molecular weight compound, administered as single intravenous injection. The mass dose of [11C]RO6924963 injected will be \ |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Standard Uptake Value (SUV), as Assessed by Tau PET Brain Scan | Day 1 up to Day 14 | |
| Part 1: Standard Uptake Value Ratio (SUVR), as Assessed by Tau PET Brain Scan | Day 1 up to Day 14 | |
| Part 1: SUV, as Assessed by Tau PET Scan of Whole Body | Day 1 up to Day 14 | |
| Part 1: SUVR, as Assessed by Tau PET Scan of Whole Body | Day 1 up to Day 14 | |
| Mean Residence Times for Each Organ, as Assessed by Tau PET Scan of Whole Body | Day 1 up to Day 14 | |
| Part 1: Distribution Volume (VT), as Assessed by Tau PET Brain Scan | Day 1 up to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2A: Absolute Percentage Difference Between Test and Retest of SUVR | Days 1, 28 | |
| Part 2A: Absolute Percentage Difference Between Test and Retest of VT | Days 1, 28 | |
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Inclusion Criteria:
Inclusion Criteria for All Participants
Inclusion Criteria for Healthy Control Participants
Inclusion Criteria for Participants with a Diagnosis of Probable AD
Exclusion Criteria:
Exclusion Criteria for All Participants
Exclusion Criteria Related to Trial Procedures
Exclusion Criterion for Participants with Probable Alzheimer's Disease
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International; Harbor Hospital Center | Baltimore | Maryland | 21225 | United States | ||
| Johns Hopkins Universtiy; Radiology Dept |
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| [11C]RO6931643 | Drug | Radiolabeled low molecular weight compound, administered as single intravenous injection. The mass dose of [11C]RO6931643 injected will be \ |
|
| [18F]RO6958948 | Drug | Radiolabeled low molecular weight compound, administered as single intravenous injection. The mass dose of [18F]RO6958948 injected will be \ |
|
| Part 2B: Effective dose (ED), as Assessed by Whole Body PET Scan |
| From the time of tracer injection on Day 1 up to 120 minutes post injection |
| Part 2A: Absolute Percentage Difference Between Test and Retest of SUV | Days 1, 28 |
| Percentage of Participants With Adverse Events (AEs) | Part 1: Day 1 up to Day 28, Part 2a: Day 1 up to Day 42, Part 2b: Day 1 up to Day 15 |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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