F 18 T807 PET (Positron Emission Tomograph )Scan for HIV Infected & Uninfected
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases, Neurology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 1/26/2019 |
| Start Date: | May 2016 |
| End Date: | November 2021 |
| Contact: | Kelley Jackson |
| Email: | jacksonk@mir.wustl.edu |
| Phone: | 314 362-1558 |
F 18 T807 Tau PET Imaging of Older (>= 40 Years Old) HIV Infected (HIV+) and HIV Uninfected (HIV-) Individuals (IND 123119, Protocol G)
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.
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.
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.
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.
Inclusion Criteria:
1. Male or female participants, ≥ 40 years of age.
2. Testing for HIV status. If positive will be included in the HIV+ group and if negative
will be included in the HIV- group.
3. Females without documented history of menopause or hysterectomy will undergo a urine
pregnancy test 24 hours prior to F 18 T807 drug administration.
Exclusion Criteria:
1. Has any condition that, in the Investigator's opinion, could increase risk to the
participant, limit the participant's ability to tolerate the experimental procedures,
or interfere with the collection/analysis of the data (for example, participants with
severe chronic back pain might not be able to lie still during the scanning
procedures).
2. Is deemed likely unable to perform the imaging procedures for any reason.
3. Has a high risk for Torsades de Pointes or is taking medications known to prolong QT
interval.
4. Has hypersensitivity to F 18 T807 or any of its excipients.
5. Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to
lie still for long periods) that make it unsafe for the individual to participate.
6. Severe claustrophobia.
7. Currently pregnant or breast-feeding.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-747-1072
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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