Flortaucipir PET Imaging in Subjects With FTD

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03040713
• Date of registration: 31/01/2017
• Prospective Registration: Yes
• Primary sponsor: Avid Radiopharmaceuticals
• Public title: Flortaucipir PET Imaging in Subjects With FTD
• Scientific title: 18F-AV-1451 PET Imaging in Subjects With Frontotemporal Dementia
• Date of first enrolment: April 11, 2017
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03040713
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Chief Medical Officer
• Affiliation: Avid Radiopharmaceuticals, Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Frontotemporal Dementia

Intervention(s)

Drug: Flortaucipir F18

Procedure: Brain PET scan

Primary Outcome(s)

Quantitative Evaluation of Flortaucipir PET Scans [Time Frame: baseline scan]

Qualitative Evaluation of Flortaucipir PET Scans [Time Frame: baseline scan]

Secondary ID(s)

18F-AV-1451-A19

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03040713