An observational study in Alzheimer Disease and HIV, sponsored by Tammie L. S. Benzinger, MD, PhD. Completed at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-22.
Sponsored by Tammie L. S. Benzinger, MD, PhD · Observational
Among 10 studies in Alzheimer Disease by Tammie L. S. Benzinger, MD, PhD — 4 open to participants now, 5 under way, none of them phase 3. Alzheimer Disease · Tammie L. S. Benzinger, MD, PhD.
Among the 10 studies in Alzheimer Disease by Tammie L. S. Benzinger, MD, PhD, this one is one of 2 that started in 2016, is one of 9 observational ones, and was the 4th registered.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's enrollment of 60 is below the median of 200 across 814 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →4 of the 10 studies in Alzheimer Disease by Tammie L. S. Benzinger, MD, PhD are open now, in 1 country. Each count lists the studies.
Of the 641 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 54 (8%) stop at 75 or younger; 34 take children under 18; 283 take healthy volunteers.
This study: 40 Years and older · all sexes · healthy volunteers too.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 2 started in 2016.
Median enrollment 0 across the 1 interventional studies, 60 across the 9 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
Tammie L. S. Benzinger, MD, PhD is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
3 of the studies in Alzheimer Disease by Tammie L. S. Benzinger, MD, PhD that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04104659Tammie L. S. Benzinger, MD, PhDStudy of Tau Imaging With the Use of [18F]MK-6240 Tracer | 2027-04-01 |
| NCT04517552Tammie L. S. Benzinger, MD, PhDInvestigation of Inflammation Using [C-11]-CS1P1 | 2027-07-01 |
| NCT04579120Tammie L. S. Benzinger, MD, PhDNeuroimaging in Healthy Aging and Senile Dementia (HASD_IND) | 2027-11 |
Among the 10 studies in Alzheimer Disease by Tammie L. S. Benzinger, MD, PhD, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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:
40 HIV+ and 40 HIV- participants will be enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Also known as: 18F-AV-1451
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
: 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
Plan to share: 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.
No publications or documents are linked to this record.
Ran from May 2016 to primary completion in May 2018, 24 months.
Of 364 non-industry observational studies under Alzheimer Disease, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 203. This study's 24 months is below that.
Counting every sponsor, half of 405 studies reached it within 67 months; a quarter within 35 and three quarters within 171.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Tammie L. S. Benzinger, MD, PhD