Follow up 18F-AV-1451 Scan in Confirmatory Cohort Subjects From Study 18F-AV-1451-A05

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Flortaucipir F18; Procedure: PET Scan

• Registration Number: NCT02795780
• Lead Sponsor: Avid Radiopharmaceuticals

Brief Summary

This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F 18 uptake over time.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-10
• Study Start: 2016-08
• Primary Completion: 2017-08-28
• Study Completion: 2017-08-28
• Disposition First Submitted: 2018-10-23
• Disposition First Submitted QC: 2018-10-23
• Disposition First Posted: 2018-10-25
• Results First Submitted: 2020-06-27
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-07
• Last Update Submitted: 2020-08-07
• Results First Posted: 2020-08-24
• Last Update Posted: 2020-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• Confirmatory cohort subjects who completed the 18F-AV-1451-A05 (NCT02016560) study

Exclusion Criteria

• Current clinically significant cardiovascular disease, ECG abnormalities, risk factors for Torsades de Pointes (TdP), or are taking drugs known to cause QT prolongation
• 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
• Have received or participated in a trial with investigational medications in the past 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Follow-up Flortaucipir PET Scan	PET Scan	-
Follow-up Flortaucipir PET Scan	Flortaucipir F18	-

Primary Outcome Measures

Name	Time	Method
Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status	18 months	Change in flortaucipir standardized uptake value ratio (SUVr) over 18 months. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. A positive change in SUVr represents an increase in tau deposition in the brain. Change = 18 month SUVr - baseline SUVr obtained in Study A05.

Trial Locations

Locations (22)

Banner Alzheimer's Institute; 🇺🇸 Phoenix, Arizona, United States

Imaging Endpoints; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

Banner Sun Health Research Institute; 🇺🇸 Sun City, Arizona, United States

Institute for Brain Aging and Dementia, UC Irvine; 🇺🇸 Irvine, California, United States

21st Century Oncology; 🇺🇸 Newport Beach, California, United States

Alzheimer's Disease Center, UC Davis; 🇺🇸 Sacramento, California, United States

California Medical Clinic for Headache; 🇺🇸 Santa Monica, California, United States

Neuropsychiatric Research Center of Southwest Florida; 🇺🇸 Fort Myers, Florida, United States

Compass Research, LLC; 🇺🇸 Orlando, Florida, United States

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