Trials / Completed
CompletedNCT03279523
F 18 T807 PET (Positron Emission Tomograph )Scan for HIV Infected & Uninfected
F 18 T807 Tau PET Imaging of Older (>= 40 Years Old) HIV Infected (HIV+) and HIV Uninfected (HIV-) Individuals (IND 123119, Protocol G)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (actual)
- Sponsor
- Tammie L. S. Benzinger, MD, PhD · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Accepted
Summary
This project will collect quantitative pilot data that will allow the characterization of uptake and binding of 18F-AV-1451 (also known as F 18 T807, also known as T807, also known as 7-(6-fluoropyridin-3-yl)-5H-pyrido\[4,3-b\]indole), a novel tau imaging compound, in older HIV+ individuals with and without HAND and matched HIV uninfected (HIV-) controls. The primary goal is to develop this highly promising tau imaging technique as an biomarker of cognitive decline in HIV+ individuals. The investigators will obtain preliminary data that will support the possibility of detecting early brain pathological changes due to HIV. Data generated from this study will be used for submission of National Institutes of Health (NIH) grants comparing tau deposition in HAND compared to other neurodegenerative disorders. It is hypothesized that specific topographies will help distinguish these neurodegenerative disorders in older individuals.
Detailed description
This protocol will demonstrate the presence of tau fibrils in older HIV+ patients with HIV associated neurocognitive disorders (HAND) compared to cognitively normal HIV+ individuals and HIV- controls. It will also demonstrate that the phenoconversion from cognitively normal (CN) status to HAND will be closely correlated with neocortical F 18 T807 uptake. In particular, HIV+ patients with MND will have greater tau cortical deposition compared to ANI individuals. The investigtors hypothesize that in vivo tau imaging will ultimately: * Demonstrate the presence of tau fibrils in older HIV+ patients with HIV associated neurocognitive disorders (HAND) compared to cognitively normal HIV+ individuals and HIV- controls. * Demonstrate that the phenoconversion from cognitively normal (CN) status to HAND will be closely correlated with neocortical F 18 T807 uptake. In particular, HIV+ patients with MND will have greater tau cortical deposition compared to ANI individuals.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | F 18 T807 | Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. |
Timeline
- Start date
- 2016-05-03
- Primary completion
- 2018-05-23
- Completion
- 2018-05-23
- First posted
- 2017-09-12
- Last updated
- 2020-09-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03279523. Inclusion in this directory is not an endorsement.