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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

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

NCT ID

NCT03040713

First Posted

January 31, 2017

Last Updated

September 3, 2020

Sponsor

Avid Radiopharmaceuticals

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

Data Monitoring Committee

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

Time Frame

baseline scan

Title

Quantitative Evaluation of Flortaucipir PET Scans

Description

Time Frame

baseline scan

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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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