Phase 1
N=16
Flortaucipir PET Imaging in Subjects With FTD
Frontotemporal Dementia
Bottom Line
View on ClinicalTrials.gov: NCT03040713 ↗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
| Outcome | Result | p-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
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.