Last reviewed · How we verify

NCT02167594

Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers

Completed Phase 1 Results posted Last updated 28 August 2020
What this trial tests

Phase 1 trial testing Flortaucipir F18 in Progressive Supranuclear Palsy in 29 participants. Completed in 11 July 2016.

Timeline
12 August 2014
Primary endpoint
11 July 2016
11 July 2016

Quick facts

Lead sponsorAvid Radiopharmaceuticals
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment29
Start date12 August 2014
Primary completion11 July 2016
Estimated completion11 July 2016
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Avid Radiopharmaceuticals — full company profile →

Who can join

Adults 50 to 85, any sex, with Progressive Supranuclear Palsy or Corticobasal Degeneration. 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.

Flortaucipir Imaging in PSP, CBD and Healthy Volunteers Primary · baseline and 9 month scans

A PSP/CBD (PSP = progressive supranuclear palsy; CBD = corticobasal degeneration) targeted composite Standardized Uptake Value ratio (SUVr) was calculated as the voxel-weighted average from the regional SUVr values of the left, right, and total globus pallidus and the dentate nuclei of the cerebellum for both the baseline and 9 month PET scans. Additionally, a global cortical Alzheimer's Disease (AD)-targeted cortical SUVr was calculated. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

Right Dentate Baseline
GroupValue95% CI
PSP Subjects1.17± 0.12
CBD Subjects1.12± 0.04
Healthy Volunteers1.03± 0.12
All Subjects1.15± 0.12
Right Dentate 9 months
GroupValue95% CI
PSP Subjects1.17± 0.11
CBD Subjects1.11± 0.05
All Subjects1.15± 0.10
Left Dentate Baseline
GroupValue95% CI
PSP Subjects1.16± 0.10
CBD Subjects1.09± 0.04
Healthy Volunteers1.08± 0.07
All Subjects1.14± 0.09
Left Dentate 9 months
GroupValue95% CI
PSP Subjects1.13± 0.11
CBD Subjects1.08± 0.05
All Subjects1.12± 0.10
Right Globus Pallidus Baseline
GroupValue95% CI
PSP Subjects1.60± 0.15
CBD Subjects1.40± 0.20
Healthy Volunteers1.29± 0.06
All Subjects1.53± 0.19
Right Globus Pallidus 9 Months
GroupValue95% CI
PSP Subjects1.58± 0.13
CBD Subjects1.47± 0.19
All Subjects1.55± 0.15
Left Globus Pallidus Baseline
GroupValue95% CI
PSP Subjects1.62± 0.15
CBD Subjects1.56± 0.32
Healthy Volunteers1.30± 0.07
All Subjects1.58± 0.21
Left Globus Pallidus 9 Months
GroupValue95% CI
PSP Subjects1.62± 0.15
CBD Subjects1.62± 0.40
All Subjects1.62± 0.21

Adverse events — posted to ClinicalTrials.gov

Time frame: End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.. Reporting threshold: 1.0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PSP Subjects
Serious: 0/20 (0%)
Deaths: 0/20
CBD Subjects
Serious: 0/6 (0%)
Deaths: 1/6
Healthy Volunteers
Serious: 0/3 (0%)
Deaths: 0/3
Other adverse events (3 terms — click to expand)

ReactionSystemPSP SubjectsCBD SubjectsHealthy Volunteers
bronchial secretion retentionRespiratory, thoracic and mediastinal disorders
muscle spasmsMusculoskeletal and connective tissue disorders
astheniaGeneral disorders

Data from ClinicalTrials.gov NCT02167594 adverse events section.

Sponsor's own description

This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.

Publications & conference data

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

  1. <sup>18</sup> F-flortaucipir tau positron emission tomography distinguishes established progressive supranuclear palsy from controls and Parkinson disease: A multicenter study.
    Schonhaut DR, McMillan CT, Spina S, Dickerson BC, et al · · 2017 · cited 140× · PMID 28980714 · DOI 10.1002/ana.25060

Verify or expand the search:

Other trials of Flortaucipir F18

Trials testing the same drug.

Other recruiting trials for Progressive Supranuclear Palsy

Currently open trials in the same condition.

Other Avid Radiopharmaceuticals trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02167594.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing