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Imaging Characteristics of a Follow-up 18F-AV-1451 Scan

Phase 2
Terminated
Conditions
Alzheimer's Disease
Interventions
Registration Number
NCT02051764
Lead Sponsor
Avid Radiopharmaceuticals
Brief Summary

This study will evaluate the imaging characteristics of flortaucipir in subjects with a previous flortaucipir scan in order to assess the rate of change of tau deposition over time.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
44
Inclusion Criteria
  • Have a previous 18F-AV-1451 brain scan
  • Can tolerate up to two Positron Emission Tomography (PET) imaging sessions and a Magnetic Resonance Imaging (MRI) scan
  • Ability to provide informed consent
Exclusion Criteria
  • Current clinically significant psychiatric disease
  • Are claustrophobic
  • Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
  • Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
  • Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
  • Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Follow-up Flortaucipir PET ScanBrain PET Scan-
Follow-up Flortaucipir PET ScanFlortaucipir F18-
Follow-up Flortaucipir PET ScanFlorbetapir F 18-
Primary Outcome Measures
NameTimeMethod
Change in Tau Depositionbaseline scan and at least 6 months after baseline scan

Rate of tau deposition change as measured by flortaucipir standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (4)

Hoag Memorial Hospital

🇺🇸

Newport Beach, California, United States

UC Irvine Medical Center

🇺🇸

Orange, California, United States

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

Center for Clinical Imaging Research, Washington University School of Medicine

🇺🇸

Saint Louis, Missouri, United States

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