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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 11, 2016

Interventions

  • Drug: Flortaucipir F18
    • IV injection, 370 megabecquerel (MBq) (10 mCi)
  • Procedure: Brain PET scan
    • positron emission tomography (PET) scan of the brain 75-105 minutes post-injection

Arms, Groups and Cohorts

  • Experimental: PSP Subjects
    • Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.
  • Experimental: CBD subjects
    • Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months.
  • Experimental: Healthy volunteers
    • Healthy volunteers receiving a flortaucipir PET scan at baseline.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Avid Radiopharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Avid Radiopharmaceuticals, Inc.

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