A Phase 2 interventional study of 18F-AV-1451 in Frontotemporal Lobar Degeneration (FTLD), Frontotemporal Dementia (FTD) and Tauopathies, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-06.
Sponsored by Columbia University · Phase 2, Interventional, and Diagnostic
Among 103 studies in Frontotemporal Dementia with a site in United States — 31 open to participants now, 45 under way, none of them phase 3. Frontotemporal Dementia · United States.
Among the 103 studies in Frontotemporal Dementia with a site in United States, this one is the 62nd largest by enrollment of the 66 interventional ones that give a count, is one of 4 that started in 2016, is one of 14 in phase 2, and was the 31st registered.
208 studies on the registry are indexed under Frontotemporal Dementia; 72 are open to participants now.
This study's enrollment of 7 is below the median of 50 across 128 interventional studies indexed under Frontotemporal Dementia.
Browse Frontotemporal Dementia studies →31 of the 103 studies in Frontotemporal Dementia with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 51 Frontotemporal Dementia studies recruiting now, 29 (57%) set no upper age limit and 5 (10%) stop at 75 or younger; 6 take children under 18; 30 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →103 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 19 · Phase 3 5 · Phase 4 3
First in 2001; this study’s year is marked. 4 started in 2016.
Median enrollment 60 across the 66 interventional studies, 201 across the 37 observational. Of the 52 that completed or were terminated, 17 (33%) have results posted.
23 of 103 have an industry lead sponsor. The 10 most frequent:
Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Columbia University has 3 studies filed under Frontotemporal Dementia — fewer than ten, so there is no comparison to draw.
14 of the studies in Frontotemporal Dementia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05262023Denali Therapeutics Inc.A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN) | 2026-12 |
| NCT03233646Duke UniversityRetinal Imaging in Neurodegenerative Disease | 2026-12-31 |
| NCT03702907Georgetown UniversityDC Longitudinal Study on Aging and Specimen Bank | 2027-01 |
| NCT05184569Peter Ljubenkov, MDVeri-T: A Trial of Verdiperstat in Patients With svPPA Due to TDP-43 Pathology | 2027-01-31 |
| NCT04516499The Bluefield Project to Cure Frontotemporal DementiaNeurofilament Surveillance Project (NSP) | 2027-02 |
Among the 103 studies in Frontotemporal Dementia with a site in United States, from their registry updates:
The study will investigate the ability of a new PET tracer, 18F-AV-1451, to detect depositions of a protein, called tau, in the brains of people with a mutation in the tau gene that causes deposition of the protein, and in people without the mutation. Up to three 18F-AV-1451 scans will be performed (one per year) on control subjects without MAPT mutations, presymptomatic mutation carriers, and symptomatic mutation carriers.
Approximately 40% of cases of Frontotemporal lobar Degeneration (FTLD) are also associated with abnormal deposition of tau protein. The purpose of this study is to image MAPT mutation carriers and their non-carrier relatives in order to study the use of this tracer as a biomarker in Frontotemporal Lobar Degeneration with tau deposition (FTLD-tau).
208 studies on the registry are indexed under Frontotemporal Dementia; 72 are open to participants now.
This study's enrollment of 7 is below the median of 50 across 128 interventional studies indexed under Frontotemporal Dementia.
Browse Frontotemporal Dementia studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Compared within Frontotemporal Dementia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Frontotemporal Lobar Degeneration. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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.
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.
Subjects who are microtubule associated protein tau (MAPT) family carriers and non-carriers will receive 18F-AV-1451 by injection, and undergo a Positron Emission Tomography (PET) scan, which will then be qualitatively analyzed to examine tau deposition in the brain.
Drug: 18F-AV-1451
A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan.
Also known as: [18F]AV-1451
SUVR of 18F-AV-1451
Regional tau deposition will be measured as standardized uptake value ratio (SUVR) of 18F-AV-1451. SUVR (80-100 min post-injection) for 18F-AV-1451 will be calculated two ways: 1) using cerebellar crus as a reference region, and 2) using the Parametric Estimation of Reference Signal Intensity (PERSI) method to create individual white matter reference regions. Binding in the inferior temporal lobe/cortex was used as the primary outcome.
Time frame: Baseline, 12-month follow up
| Milestone | 18F-AV-1451 |
|---|---|
| Started | 7 |
| Completed | 7 |
| Not completed | 0 |
Regional tau deposition will be measured as standardized uptake value ratio (SUVR) of 18F-AV-1451. SUVR (80-100 min post-injection) for 18F-AV-1451 will be calculated two ways: 1) using cerebellar crus as a reference region, and 2) using the Parametric Estimation of Reference Signal Intensity (PERSI) method to create individual white matter reference regions. Binding in the inferior temporal lobe/cortex was used as the primary outcome.
| standardized uptake value ratio (SUVR) | 18F-AV-1451 - Non-carriers | 18F-AV-1451 - Carriers |
|---|---|---|
| Inferior temporal cortex (Cerebellar crus) | 1.07 (0.99 to 1.14) | 1.26 (1.21 to 1.26) |
| Inferior temporal cortex (PERSI) | 1.03 (1.01 to 1.05) | 1.34 (1.26 to 1.36) |
Collected over Up to 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 18F-AV-1451 | 0/7 (0%) | 0/7 (0%) | 4/7 (57.1%) |
| Event | 18F-AV-1451 |
|---|---|
| InsomniaGeneral disorders | 2/7 |
| HeadacheGeneral disorders | 2/7 |
| Age, Customized(Participants) | 18F-AV-1451 |
|---|---|
| 18-21 years | 0 |
| 22-29 years | 1 |
| 30-39 years | 1 |
| 40-49 years | 0 |
| 50-59 years | 4 |
| 60-69 years | 1 |
| Sex: Female, Male(Participants) | 18F-AV-1451 |
|---|---|
| Female | 5 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | 18F-AV-1451 |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | 18F-AV-1451 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | 18F-AV-1451 |
|---|---|
| United States | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified clinical characteristics subjects such as age, mutation and rating scale/score of mental state in the manuscript.
Time frame: Availability of the manuscript through journal editors
Access criteria: Availability of the manuscript through journal editors
Ran from Apr 2016 to primary completion in Nov 2018, 31 months.
Results were first posted in Dec 2019, 1 year after primary completion.
Of 19 phase 2 interventional studies under Frontotemporal Dementia, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 64. This study's 31 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Flortaucipir