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The study aims to compare tau targeted radiotracers [18F]GTP1 and [18F]PI-2620 or [18F]MK-6240 in subjects with normal cognition or prodromal to moderate Alzheimer's disease (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]PI-2620 PET, then [18F]GTP1 PET | Experimental | Participants will undergo one [18F]PI-2620 PET imaging session, then one [18F]GTP1 PET imaging session. Prior to each session, participants will be administered a bolus intravenous injection of approximately 5 millicurie (mCi) of [18F]PI-2620 or 7mCi of [18F]GTP1. |
|
| [18F]GTP1 PET, then [18F]MK-6240 | Experimental | Participants will undergo one [18F]GTP1 PET imaging session, then one [18F]MK-6240 PET imaging session. Prior to each session, participants will be administered a bolus intravenous injection of approximately 5 millicurie (mCi) of [18 F]MK-6240 or 7mCi of [18F]GTP1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]GTP1 | Drug | Participants will receive a bolus IV of approximately 7mCi of [18F]GTP1 radiotracer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) | Up to approximately 4 days after administration of each radiotracer | |
| Brain tau burden as measured by [18F]PI-2620 - PET | Approximately 1 hour after injection of [18F]PI-2620 | |
| Brain tau burden as measured by [18F]GTP1 - PET | Approximately 1 hour after injection of [18F]PI-2620 | |
| Brain tau burden as measured by [18F]MK-6240 - PET | Approximately 1 hour after injection of [18F]MK-6240 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Invicro, a Konica Minolta company | New Haven | Connecticut | 06510 | United States |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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| [18F]PI-2620 | Drug | Participants will receive a bolus IV of approximately 5mCi of [18F]PI-2620 radiotracer. |
|
| [18F]MK-6240 | Drug | Participants will receive a bolus IV of approximately 5mCi of [18F]MK-6240 radiotracer. |
|
| 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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| ID | Term |
|---|---|
| C000710691 | (18F)GTP1 |
| C000710692 | ((18)F)PI-2620 |
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