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OpenTrials
Completed

NCT Number: NCT02167594

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

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

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cognitively Healthy Volunteers

  • Mini-mental state examination (MMSE) ≥ 28
  • No history of cognitive decline or parkinsonian motor disorder

CBD and PSP subjects

  • Able to walk 10 steps with minimal assistance
  • MMSE ≥ 14 and ≤ 30
  • Subject has a reliable study partner who agrees to accompany subject to visits and spends at least 5 hours per week with the subject

PSP subjects only

  • Meet National Institute of Neurological Disorders and Stroke - Society for Progressive Supranuclear Palsy (NINDS-SPSP) probable or possible PSP criteria as modified for the Neuroprotection and Natural History Parkinson Plus Syndromes (NNIPPS) clinical trial

CBD subjects only

  • Meets 2013 consensus criteria for possible or probable corticobasal degeneration, corticobasal syndrome (CBS) subtype

Exclusion criteria

All subjects

  • Have evidence of structural abnormalities such as vascular disease, large strokes or severe white matter disease or other mass lesion on screening MRI
  • Claustrophobia
  • Current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (e.g. corrected QT interval >450 msec)
  • Have a history of risk factors for Torsades de Pointes (e.g. heart failure, hypokalemia, family history of long QT syndrome)
  • Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
  • Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
  • Have received or participated in a trial with investigational medications in the past 30 days
  • Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
  • Have a history of neuroleptic use for a prolonged period of time or within the past 6 months

PSP and CBD subjects

  • Have evidence of amyloid deposition
  • Meet National Institute on Aging-Alzheimer's Association criteria for probable Alzheimer's Disease
  • Have any other neurological condition other than CBS or PSP that could account for cognitive or motor deficits
  • Serum or plasma progranulin level less than one standard deviation below the normal subject mean for the laboratory performing the assay
  • Have a high-risk family history suggestive of tar DNA binding protein (TDP)-43 pathology or known mutations

Treatment and study plan

Flortaucipir F18

Drug

IV injection, 370 megabecquerel (MBq) (10 mCi)

Other names: [F18]T807, 18F-AV-1451, LY3191748, Tauvid

Brain PET scan

Procedure

positron emission tomography (PET) scan of the brain 75-105 minutes post-injection

Primary outcomes

  1. Flortaucipir Imaging in PSP, CBD and Healthy Volunteers

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Registry information

Official study title

18F-AV-1451 Injection for Brain Imaging of Tau in Subjects With Progressive Supranuclear Palsy (PSP), Subjects With Corticobasal Degeneration (CBD) and Healthy Volunteers

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 19, 2014
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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