NCT03040713

Flortaucipir PET Imaging in Subjects With FTD

Completed Phase 1 Results posted Last updated 25 September 2020

What this trial tests

Phase 1 trial testing Flortaucipir F18 in Frontotemporal Dementia in 16 participants. Completed in 24 October 2018.

Timeline

11 April 2017

Primary endpoint
24 October 2018

24 October 2018

Quick facts

Lead sponsor	Avid Radiopharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	16
Start date	11 April 2017
Primary completion	24 October 2018
Estimated completion	24 October 2018
Sites	3 locations across United States

Drugs / interventions tested

• Flortaucipir F18 — full drug profile →
• Brain PET scan

Conditions studied

• Frontotemporal Dementia — all drugs for Frontotemporal Dementia →

Sponsor

Avid Radiopharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Frontotemporal Dementia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Qualitative Evaluation of Flortaucipir PET Scans Primary · baseline scan

Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's Disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal

Group	Value	95% CI
FTD Subjects	0
FTD Subjects	0
FTD Subjects	13

Quantitative Evaluation of Flortaucipir PET Scans Primary · baseline scan

Standard Uptake Value Ratio (SUVr) using a weighted cortical average (MUBADA), and individual regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

MUBADA

Group	Value	95% CI
FTD Subjects	1.00903	± 0.036582

Parietal

Group	Value	95% CI
FTD Subjects	0.91992	± 0.054753

Temporal

Group	Value	95% CI
FTD Subjects	0.94920	± 0.041189

Frontal

Group	Value	95% CI
FTD Subjects	0.89825	± 0.086118

Caudate

Group	Value	95% CI
FTD Subjects	0.63508	± 0.130466

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs were collected at scan visit and for 48 hours after flortaucipir administration.. Reporting threshold: 0.5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FTD Subjects Safety Population

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (4 terms — click to expand)

Reaction	System	FTD Subjects Safety Popula…
Feeling cold	General disorders	—
Injection site pain	General disorders	—
Headache	Nervous system disorders	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—

Data from ClinicalTrials.gov NCT03040713 adverse events section.

Sponsor's own description

This study is designed to assess the usefulness of flortaucipir in Positron Emission Tomography (PET) imaging for subjects diagnosed with Frontotemporal Dementia (FTD).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 18F-flortaucipir PET to autopsy comparisons in Alzheimer's disease and other neurodegenerative diseases.
   Soleimani-Meigooni DN, Iaccarino L, La Joie R, Baker S, et al · · 2020 · cited 129× · PMID 33141172 · DOI 10.1093/brain/awaa276