search
Back to results

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

Primary Purpose

Progressive Supranuclear Palsy, Corticobasal Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Flortaucipir F18
Brain PET scan
Sponsored by
Avid Radiopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Progressive Supranuclear Palsy

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • UCSD Movement Disorder Clinic
  • UCSF Neurosciences Clinical Research Unit
  • Molecular Neuroimaging
  • Perelman School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

PSP Subjects

CBD subjects

Healthy volunteers

Arm Description

Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.

Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months.

Healthy volunteers receiving a flortaucipir PET scan at baseline.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 17, 2014
Last Updated
August 21, 2020
Sponsor
Avid Radiopharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT02167594
Brief Title
Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 12, 2014 (Actual)
Primary Completion Date
July 11, 2016 (Actual)
Study Completion Date
July 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Supranuclear Palsy, Corticobasal Degeneration

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PSP Subjects
Arm Type
Experimental
Arm Description
Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.
Arm Title
CBD subjects
Arm Type
Experimental
Arm Description
Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months.
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
Healthy volunteers receiving a flortaucipir PET scan at baseline.
Intervention Type
Drug
Intervention Name(s)
Flortaucipir F18
Other Intervention Name(s)
[F18]T807, 18F-AV-1451, LY3191748, Tauvid
Intervention Description
IV injection, 370 megabecquerel (MBq) (10 mCi)
Intervention Type
Procedure
Intervention Name(s)
Brain PET scan
Intervention Description
positron emission tomography (PET) scan of the brain 75-105 minutes post-injection
Primary Outcome Measure Information:
Title
Flortaucipir Imaging in PSP, CBD and Healthy Volunteers
Description
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.
Time Frame
baseline and 9 month scans

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Avid Radiopharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UCSD Movement Disorder Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UCSF Neurosciences Clinical Research Unit
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Molecular Neuroimaging
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Perelman School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs