Flortaucipir PET Imaging in Subjects With FTD
18F-AV-1451 PET Imaging in Subjects With Frontotemporal Dementia
1 other identifier
interventional
16
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2017
CompletedFirst Posted
Study publicly available on registry
February 2, 2017
CompletedStudy Start
First participant enrolled
April 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2018
CompletedResults Posted
Study results publicly available
September 25, 2020
CompletedSeptember 25, 2020
September 1, 2020
1.5 years
January 31, 2017
July 24, 2020
September 3, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
FTD Subjects
EXPERIMENTALSubjects 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
Interventions
370 megabecquerel (MBq)(10 millicurie \[mCi\]) injection, single dose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Movement Disorder Center, UCSD
La Jolla, California, 92037, United States
Memory and Aging Center, UCSF
San Francisco, California, 94158, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Related Publications (1)
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.
PMID: 33141172DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Avid Radiopharmaceuticals, Inc.
Study Officials
- STUDY CHAIR
Chief Medical Officer
Avid Radiopharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2017
First Posted
February 2, 2017
Study Start
April 11, 2017
Primary Completion
October 24, 2018
Study Completion
October 24, 2018
Last Updated
September 25, 2020
Results First Posted
September 25, 2020
Record last verified: 2020-09