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

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

Study Overview

• Status: Completed
• Conditions: Corticobasal Degeneration; Progressive Supranuclear Palsy
• Intervention / Treatment: Drug: Flortaucipir F18; Procedure: Brain PET scan

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • La Jolla, California, United States, 92037
      • UCSD Movement Disorder Clinic
    • San Francisco, California, United States, 94158
      • UCSF Neurosciences Clinical Research Unit
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Molecular NeuroImaging
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Perelman School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PSP Subjects; Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.	Drug: Flortaucipir F18; IV injection, 370 megabecquerel (MBq) (10 mCi); Other Names: 18F-AV-1451; LY3191748; Tauvid; [F18]T807; Procedure: Brain PET scan; positron emission tomography (PET) scan of the brain 75-105 minutes post-injection
Experimental: CBD subjects; Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months.	Drug: Flortaucipir F18; IV injection, 370 megabecquerel (MBq) (10 mCi); Other Names: 18F-AV-1451; LY3191748; Tauvid; [F18]T807; Procedure: Brain PET scan; positron emission tomography (PET) scan of the brain 75-105 minutes post-injection
Experimental: Healthy volunteers; Healthy volunteers receiving a flortaucipir PET scan at baseline.	Drug: Flortaucipir F18; IV injection, 370 megabecquerel (MBq) (10 mCi); Other Names: 18F-AV-1451; LY3191748; Tauvid; [F18]T807; Procedure: Brain PET scan; positron emission tomography (PET) scan of the brain 75-105 minutes post-injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flortaucipir Imaging in PSP, CBD and Healthy Volunteers	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.	baseline and 9 month scans

Collaborators and Investigators

• Sponsor: Avid Radiopharmaceuticals
• Investigators: Study Director: Medical Director, Avid Radiopharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2014
• Primary Completion (Actual): July 11, 2016
• Study Completion (Actual): July 11, 2016

Study Registration Dates

• First Submitted: June 17, 2014
• First Submitted That Met QC Criteria: June 18, 2014
• First Posted (Estimate): June 19, 2014

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 21, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Tauopathies; Cranial Nerve Diseases; Ocular Motility Disorders; Paralysis; Ophthalmoplegia; Supranuclear Palsy, Progressive
• Other Study ID Numbers: 18F-AV-1451-A09