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Phase 1 N=16 Diagnostic

Flortaucipir PET Imaging in Subjects With FTD

Frontotemporal Dementia

Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Qualitative Evaluation of Flortaucipir PET Scans — 0; 0; 13 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Flortaucipir F18 (Drug); Brain PET scan (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Avid Radiopharmaceuticals
Primary completion
Oct 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Qualitative Evaluation of Flortaucipir PET Scans
0; 0; 13
PRIMARY
Quantitative Evaluation of Flortaucipir PET Scans
1.00903; 0.91992; 0.94920; 0.89825; 0.63508

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03040713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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