Clinical trial NCT03040713: Flortaucipir PET Imaging in Subjects With FTD
Official title: 18F-AV-1451 PET Imaging in Subjects With Frontotemporal Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Frontotemporal Dementia
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-02-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


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

Primary outcomes:
measure: Qualitative Evaluation of Flortaucipir PET Scans
timeFrame: baseline scan
measure: Quantitative Evaluation of Flortaucipir PET Scans
timeFrame: baseline scan
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Movement Disorder Center, UCSD
state: California
city: San Francisco
country: United States
facility: Memory and Aging Center, UCSF
state: California
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: Avid Radiopharmaceuticals, Inc.
name: Chief Medical Officer
role: STUDY_CHAIR
References:
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.