Flortaucipir PET Imaging in Subjects With FTD

Frontotemporal Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040713
• Other study ID #: 18F-AV-1451-A19
• Status: Completed
• Phase: Phase 1
• Start date: April 11, 2017
• Est. completion date: October 24, 2018

Study information

• Verified date: September 2020
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 24, 2018
• Est. primary completion date: October 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia, Primary Progressive
• Dementia
• Frontotemporal Dementia
• Pick Disease of the Brain

Intervention

Drug:
• Flortaucipir F18
370 megabecquerel (MBq)(10 millicurie [mCi]) injection, single dose

Procedure:
• Brain PET scan
positron emission tomography (PET) scan of the brain

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Movement Disorder Center, UCSD	La Jolla	California
United States	Memory and Aging Center, UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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