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

Alzheimer's Disease Clinical Trial

Official title:

An Open Label, Multicenter Study, Evaluating the Imaging Characteristics of a Follow-up 18F-AV-1451 Scan in Subjects Who Have Had a Prior 18F-AV-1451 Scan

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02051764
• Other study ID #: 18F-AV-1451-A04
• Status: Terminated
• Phase: Phase 2
• Start date: May 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2020
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Flortaucipir F18
370 megabecquerel (MBq) IV single-dose
• Florbetapir F 18
370 megabecquerel (MBq) IV single-dose

Procedure:
• Brain PET Scan
positron emission tomography (PET) scan of the brain

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Hoag Memorial Hospital	Newport Beach	California
United States	UC Irvine Medical Center	Orange	California
United States	Center for Clinical Imaging Research, Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Tau Deposition	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.	baseline scan and at least 6 months after baseline scan