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Flortaucipir PET Imaging in Subjects With FTD

Primary Purpose

Frontotemporal Dementia

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 Frontotemporal Dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects diagnosed by a dementia specialist with symptomatic clinical syndromes with expected Frontotemporal Dementia (FTD) pathology will be enrolled. Clinical syndromes associated with FTD pathology include: behavioral-variant FTD, FTD with motor-neuron disease, non-fluent/agrammatic and semantic variants of primary progressive aphasia, progressive supranuclear palsy syndrome and corticobasal syndrome.
  • Have provided informed consent or have a legally authorized (LAR) provide consent for study procedures
  • Have had volumetric brain MRI obtained in site's companion protocol within one year of enrollment
  • Can tolerate PET scan procedures

Exclusion Criteria:

  • Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances that pose potential safety risk
  • Have history of risk factors for Torsades de Pointes (TdP) or taking medication known to cause QT prolongation
  • Have history of drug or alcohol dependence within the last year
  • Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraception
  • Have history of relevant severe drug allergy or hypersensitivity
  • Have received an investigational medication under FDA IND protocol within 30 days of planned imaging session
  • Have received a radiopharmaceutical for imaging/therapy within 24 hours of imaging session
  • Possess PET scan evidence of amyloid deposition
  • Determined by the investigator to be unsuitable for this type of study

Sites / Locations

  • Movement Disorder Center, UCSD
  • Memory and Aging Center, UCSF
  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FTD Subjects

Arm Description

Subjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or tar DNA binding protein (TDP)-43 pathology receiving a flortaucipir PET scan

Outcomes

Primary Outcome Measures

Qualitative Evaluation of Flortaucipir PET Scans
Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's Disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.
Quantitative Evaluation of Flortaucipir PET Scans
Standard Uptake Value Ratio (SUVr) using a weighted cortical average (MUBADA), and individual regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2017
Last Updated
September 3, 2020
Sponsor
Avid Radiopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03040713
Brief Title
Flortaucipir PET Imaging in Subjects With FTD
Official Title
18F-AV-1451 PET Imaging in Subjects With Frontotemporal Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
October 24, 2018 (Actual)
Study Completion Date
October 24, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to assess the usefulness of flortaucipir in Positron Emission Tomography (PET) imaging for subjects diagnosed with Frontotemporal Dementia (FTD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontotemporal Dementia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FTD Subjects
Arm Type
Experimental
Arm Description
Subjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or tar DNA binding protein (TDP)-43 pathology receiving a flortaucipir PET scan
Intervention Type
Drug
Intervention Name(s)
Flortaucipir F18
Other Intervention Name(s)
18F-AV-1451, [F-18]T807, LY3191748, Tauvid
Intervention Description
370 megabecquerel (MBq)(10 millicurie [mCi]) injection, single dose
Intervention Type
Procedure
Intervention Name(s)
Brain PET scan
Intervention Description
positron emission tomography (PET) scan of the brain
Primary Outcome Measure Information:
Title
Qualitative Evaluation of Flortaucipir PET Scans
Description
Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's Disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.
Time Frame
baseline scan
Title
Quantitative Evaluation of Flortaucipir PET Scans
Description
Standard Uptake Value Ratio (SUVr) using a weighted cortical average (MUBADA), and individual regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Time Frame
baseline scan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects diagnosed by a dementia specialist with symptomatic clinical syndromes with expected Frontotemporal Dementia (FTD) pathology will be enrolled. Clinical syndromes associated with FTD pathology include: behavioral-variant FTD, FTD with motor-neuron disease, non-fluent/agrammatic and semantic variants of primary progressive aphasia, progressive supranuclear palsy syndrome and corticobasal syndrome. Have provided informed consent or have a legally authorized (LAR) provide consent for study procedures Have had volumetric brain MRI obtained in site's companion protocol within one year of enrollment Can tolerate PET scan procedures Exclusion Criteria: Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances that pose potential safety risk Have history of risk factors for Torsades de Pointes (TdP) or taking medication known to cause QT prolongation Have history of drug or alcohol dependence within the last year Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraception Have history of relevant severe drug allergy or hypersensitivity Have received an investigational medication under FDA IND protocol within 30 days of planned imaging session Have received a radiopharmaceutical for imaging/therapy within 24 hours of imaging session Possess PET scan evidence of amyloid deposition Determined by the investigator to be unsuitable for this type of study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Avid Radiopharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Movement Disorder Center, UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Memory and Aging Center, UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33141172
Citation
Soleimani-Meigooni DN, Iaccarino L, La Joie R, Baker S, Bourakova V, Boxer AL, Edwards L, Eser R, Gorno-Tempini ML, Jagust WJ, Janabi M, Kramer JH, Lesman-Segev OH, Mellinger T, Miller BL, Pham J, Rosen HJ, Spina S, Seeley WW, Strom A, Grinberg LT, Rabinovici GD. 18F-flortaucipir PET to autopsy comparisons in Alzheimer's disease and other neurodegenerative diseases. Brain. 2020 Dec 5;143(11):3477-3494. doi: 10.1093/brain/awaa276.
Results Reference
derived

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Flortaucipir PET Imaging in Subjects With FTD

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