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| Name | Class |
|---|---|
| Institute for Neurodegenerative Disorders | OTHER |
| Roche Pharma AG | INDUSTRY |
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The primary objective of this exploratory imaging study is to further characterize [18F]T807, an investigational PET radioligand for imaging Tau (thought to be a downstream biomarker indicative of neurodegeneration in conditions such as AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]T807 | Experimental | At the [18F]T807 PET imaging visit, subjects will be given a bolus injection of no more than 10 mCi (370 MBq) of [18F]T807 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]T807 | Drug | All enrolled subjects will undergo an [18F]T807 PET imaging visit. In addition, subjects with AD and aged volunteers will have one PET scan with Amyvid (florbetapir F 18 injection) as part of the screening activities to measure Aβ in the brain. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative evaluation of [18F]T807 as a potential PET radioligand for imaging Tau in patients with clinically characterized tauopathies | To further characterize [18F]T807, an investigational PET radioligand for imaging Tau (thought to be a downstream biomarker indicative of neurodegeneration in conditions such as AD) and to assess the full quantitative evaluation of the PET outcome measures using [18F]T807 by pharmacokinetic (PK) modeling in order to derive a volume of distribution (VT) of [18F]T807 using arterial input function. | 1 year |
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Inclusion Criteria:
For all Subjects:
Prodromal and Mild Alzheimer's Disease Subjects
Healthy Volunteers
Exclusion Criteria:
For All subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Danna Jennings, MD | Institute for Neurodegenerative Disorders | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Molecular NeuroImaging, LLC | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3496763 | Background | Fazekas F, Chawluk JB, Alavi A, Hurtig HI, Zimmerman RA. MR signal abnormalities at 1.5 T in Alzheimer's dementia and normal aging. AJR Am J Roentgenol. 1987 Aug;149(2):351-6. doi: 10.2214/ajr.149.2.351. | |
| 1202204 | Background | Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available. |
| Label | URL |
|---|---|
| Molecular NeuroImaging | View source |
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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 |
|---|---|
| C000591008 | 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole |
| C545186 | florbetapir |
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| 9339696 | Background | Moroney JT, Bagiella E, Desmond DW, Hachinski VC, Molsa PK, Gustafson L, Brun A, Fischer P, Erkinjuntti T, Rosen W, Paik MC, Tatemichi TK. Meta-analysis of the Hachinski Ischemic Score in pathologically verified dementias. Neurology. 1997 Oct;49(4):1096-105. doi: 10.1212/wnl.49.4.1096. |
| 27908967 | Derived | Barret O, Alagille D, Sanabria S, Comley RA, Weimer RM, Borroni E, Mintun M, Seneca N, Papin C, Morley T, Marek K, Seibyl JP, Tamagnan GD, Jennings D. Kinetic Modeling of the Tau PET Tracer 18F-AV-1451 in Human Healthy Volunteers and Alzheimer Disease Subjects. J Nucl Med. 2017 Jul;58(7):1124-1131. doi: 10.2967/jnumed.116.182881. Epub 2016 Dec 1. |
| Institute for Neurodenerative Disorders | View source |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |