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| ID | Type | Description | Link |
|---|---|---|---|
| G0097 | Other Identifier | InVicro |
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This is an open-label, longitudinal observational study evaluating the imaging characteristics of the tau positron-emission tomography (PET) radioligand [18F] Genentech Tau Probe 1 (GTP1) in the brain of participants with prodromal, mild, and moderate Alzheimer's disease (AD) compared to healthy participants. The overall goal of this protocol is to evaluate the longitudinal change in tau burden using [18F]GTP1, a tau targeted radiopharmaceutical.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]GTP1 | Experimental | Participants will complete [18F]GTP1 PET imaging at four time points: Baseline, 6 months, 12 months and 18 months. For each [18F]GTP1 imaging session, the following procedure will be performed: a catheter will be placed for intravenous (IV) administration of [18F]GTP1. Participants will receive an IV bolus injection of up to 370 megabecquerel (MBq) (10 millicurie [mCi]) of [18F]GTP1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]GTP1 | Drug | Participants will receive [18F]GTP1 as per the schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Standardized Uptake Value Ratio (SUVR) as Measured by [18F]GTP1 | From Baseline to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)13 | From Baseline to 18 months | |
| Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Volumetric Magnetic Resonance Imaging (MRI) Measures |
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Inclusion Criteria:
For All Participants:
- Availability of a study partner who, in the investigator's judgment, has frequent and sufficient contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to accompany the participant and provide information at visits
For Healthy Participants:
For Participants With a Diagnosis of AD:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Molecular NeuroImaging | New Haven | Connecticut | 06510 | United States | ||
| KI Health Partners, LLC; New England Institute for Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38606196 | Derived | Sanabria Bohorquez SM, Baker S, Manser PT, Tonietto M, Galli C, Wildsmith KR, Zou Y, Kerchner GA, Weimer R, Teng E. Evaluation of partial volume correction and analysis of longitudinal [18F]GTP1 tau PET imaging in Alzheimer's disease using linear mixed-effects models. Front Neuroimaging. 2024 Mar 28;3:1355402. doi: 10.3389/fnimg.2024.1355402. eCollection 2024. | |
| 34852837 |
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| From Baseline to 18 months |
| Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Cerebrospinal Fluid (CSF) Markers | From Baseline to 18 months |
| Percentage of Participants With Adverse Events (AEs) | From Baseline to 18 months |
| Test-Retest Variability Based on [18F]GTP1 PET Scans | From date of test scan to 7-21 days after test scan |
| Stamford |
| Connecticut |
| 06905 |
| United States |
| Neuropsychiatric Research; Center of Southwest Florida | Fort Myers | Florida | 33912 | United States |
| Miami Jewish Health Systems | Miami | Florida | 33137 | United States |
| Bioclinica Research | Orlando | Florida | 32806 | United States |
| Emory University | Atlanta | Georgia | 30303 | United States |
| NeuroStudies.net, LLC | Decatur | Georgia | 30033 | United States |
| Acadia Clinical Research; Dr. Henderson's Office | Bangor | Maine | 04401 | United States |
| Donald S. Marks, M.D., P.C.; Medical Center | Plymouth | Massachusetts | 02360 | United States |
| Alzheimers Disease Center | Quincy | Massachusetts | 02169 | United States |
| NeuroCognitive Institute | Mount Arlington | New Jersey | 07856 | United States |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | United States |
| Advanced Medical Research | Maumee | Ohio | 43537 | United States |
| Lehigh Center Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | United States |
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
| Teng E, Manser PT, Sanabria Bohorquez S, Wildsmith KR, Pickthorn K, Baker SL, Ward M, Kerchner GA, Weimer RM. Baseline [18F]GTP1 tau PET imaging is associated with subsequent cognitive decline in Alzheimer's disease. Alzheimers Res Ther. 2021 Dec 1;13(1):196. doi: 10.1186/s13195-021-00937-x. |
| 31834365 | Derived | Blennow K, Chen C, Cicognola C, Wildsmith KR, Manser PT, Bohorquez SMS, Zhang Z, Xie B, Peng J, Hansson O, Kvartsberg H, Portelius E, Zetterberg H, Lashley T, Brinkmalm G, Kerchner GA, Weimer RM, Ye K, Hoglund K. Cerebrospinal fluid tau fragment correlates with tau PET: a candidate biomarker for tangle pathology. Brain. 2020 Feb 1;143(2):650-660. doi: 10.1093/brain/awz346. |
| 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 |
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