Flortaucipir PET Imaging in Subjects With FTD

18F-AV-1451 PET Imaging in Subjects With Frontotemporal Dementia

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

Study Overview

• Status: Completed
• Conditions: Frontotemporal Dementia
• Intervention / Treatment: Procedure: Brain PET scan; Drug: Flortaucipir F18

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Movement Disorder Center, UCSD
    • San Francisco, California, United States, 94158
      • Memory and Aging Center, UCSF
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FTD Subjects; 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	Procedure: Brain PET scan; positron emission tomography (PET) scan of the brain; Drug: Flortaucipir F18; 370 megabecquerel (MBq)(10 millicurie [mCi]) injection, single dose; Other Names: 18F-AV-1451; [F-18]T807; LY3191748; Tauvid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline scan
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.	baseline scan

Collaborators and Investigators

• Sponsor: Avid Radiopharmaceuticals

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2017
• Primary Completion (ACTUAL): October 24, 2018
• Study Completion (ACTUAL): October 24, 2018

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (ESTIMATE): February 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: 18F-AV-1451-A19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No