Alzheimer DiseaseNCT03279523
F 18 T807 PET (Positron Emission Tomograph )Scan for HIV Infected & Uninfected
An observational study of Alzheimer Disease and HIV, run by Tammie L. S. Benzinger, MD, PhD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, HIV
- What is being tested?
- F 18 T807
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2016to 23 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 40 HIV+ and 40 HIV- participants will be enrolled.
Who may be able to join
- Male or female participants, ≥ 40 years of age.
- Testing for HIV status. If positive will be included in the HIV+ group and if negative will be included in the HIV- group.
- Females without documented history of menopause or hysterectomy will undergo a urine pregnancy test 24 hours prior to F 18 T807 drug administration.
Who cannot join
- 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).
- Is deemed likely unable to perform the imaging procedures for any reason.
- Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
- Has hypersensitivity to F 18 T807 or any of its excipients.
- 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.
- Severe claustrophobia.
- Currently pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the 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
- Alzheimer Disease, HIV
- Being tested
- F 18 T807
- Keywords
- Dementia, HIV, Brain Disease, CNS Diseases, Mild Cognitive Impairment, Neurodegenerative Disease, Tauopathies
- Medical subject headings
- Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Cognitive Dysfunction, Neurodegenerative Diseases, Tauopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F 18 T807Drug
Also called 18F-AV-1451
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: F 18 T807 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perform human in vivo tau imaging using F 18 T807 in 30 older (≥ 40 years old) HIV+ participants and 30 HIV- controls.
Measured: 5 years
Secondary outcomes (1)
: Correlate regional quantitative T807 binding potentials (BPs) with cognitive impairment, as documented by neuropsychological performance tests, in HIV+ and HIV- individuals.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start3 May 2016
- Primary completion23 May 2018
- Study completion23 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tammie L. S. Benzinger, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tammie L. S. Benzinger, MD, PhD, Washington University School of Medicine
- Investigators
- Tammie Benzinger, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279523
- Sponsor's protocol ID
- IND 123119 Protocol G
- Status last verified
- Sep 2020
- First submitted
- 3 May 2016
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: As part of this study, we are obtaining data from the participant. We would like to use this data' for studies going on right now as well as studies that are conducted in the future. These studies may provide additional information that will be helpful in understanding cognitive impairment, or other diseases or conditions, including research to develop investigational tests, treatments, drugs or devices that are not yet approved by the U.S. Food and Drug Administration. It is unlikely that what we learn from these studies will have a direct benefit to the participant.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F 18 T807 Tau PET Imaging of Older (>= 40 Years Old) HIV Infected (HIV+) and HIV Uninfected (HIV-) Individuals (IND 123119, Protocol G)
- ClinicalTrials.gov ID
- NCT03279523
- Acronym / sponsor ID
- IND 123119 Protocol G
- Conditions
- Alzheimer Disease, HIV
- Keywords
- Dementia, HIV, Brain Disease, CNS Diseases, Mild Cognitive Impairment, Neurodegenerative Disease, Tauopathies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tammie L. S. Benzinger, MD, PhDUniversity, hospital or other
- Study start
- 3 May 2016 (actual)
- Primary completion
- 23 May 2018 (actual)
- Study completion
- 23 May 2018 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F 18 T807 | – | Drug: F 18 T807Participants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 40 HIV+ and 40 HIV- participants will be enrolled.
Key inclusion criteria (3 listed)
- Male or female participants, ≥ 40 years of age.
- Testing for HIV status. If positive will be included in the HIV+ group and if negative will be included in the HIV- group.
- Females without documented history of menopause or hysterectomy will undergo a urine pregnancy test 24 hours prior to F 18 T807 drug administration.
Key exclusion criteria (7 listed)
- 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).
- Is deemed likely unable to perform the imaging procedures for any reason.
- Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
- Has hypersensitivity to F 18 T807 or any of its excipients.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F 18 T807Also: 18F-AV-1451Participants 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. | Drug | F 18 T807 |
Primary outcome
Perform human in vivo tau imaging using F 18 T807 in 30 older (≥ 40 years old) HIV+ participants and 30 HIV- controls.
Time frame: 5 years
1 secondary outcome
: Correlate regional quantitative T807 binding potentials (BPs) with cognitive impairment, as documented by neuropsychological performance tests, in HIV+ and HIV- individuals.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Individual participant dataSharing planned: Yes. As part of this study, we are obtaining data from the participant. We would like to use this data' for studies going on right now as well as studies that are conducted in the future. These studies may provide additional information that will be helpful in understanding cognitive impairment, or other diseases or conditions, including research to develop investigational tests, treatments, drugs or devices that are not yet approved by the U.S. Food and Drug Administration. It is unlikely that what we learn from these studies will have a direct benefit to the participant.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tammie Benzinger, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and HIV, run by Tammie L. S. Benzinger, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perform human in vivo tau imaging using F 18 T807 in 30 older (≥ 40 years old) HIV+ participants and 30 HIV- controls. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.