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

NCT ID: NCT02795780

Last Updated: 2020-08-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-08-28

Brief Summary

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

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Follow-up Flortaucipir PET Scan

Group Type EXPERIMENTAL

Flortaucipir F18

Intervention Type DRUG

370 megabecquerel (MBq) IV single-dose

PET Scan

Intervention Type PROCEDURE

positron emission tomography (PET) scan

Interventions

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Flortaucipir F18

370 megabecquerel (MBq) IV single-dose

Intervention Type DRUG

PET Scan

positron emission tomography (PET) scan

Intervention Type PROCEDURE

Other Intervention Names

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T807 18F-AV-1451

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Avid Radiopharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Banner Alzheimer's Institute

Phoenix, Arizona, United States

Site Status

Imaging Endpoints

Scottsdale, Arizona, United States

Site Status

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Site Status

Banner Sun Health Research Institute

Sun City, Arizona, United States

Site Status

Institute for Brain Aging and Dementia, UC Irvine

Irvine, California, United States

Site Status

21st Century Oncology

Newport Beach, California, United States

Site Status

Alzheimer's Disease Center, UC Davis

Sacramento, California, United States

Site Status

California Medical Clinic for Headache

Santa Monica, California, United States

Site Status

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, United States

Site Status

Compass Research, LLC

Orlando, Florida, United States

Site Status

Meridien Research

St. Petersburg, Florida, United States

Site Status

University of South Florida Health Byrd Alzheimer's Institute

Tampa, Florida, United States

Site Status

Premiere Research Institute

West Palm Beach, Florida, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Boston University School of Medicine

Boston, Massachusetts, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Las Vegas Radiology

Las Vegas, Nevada, United States

Site Status

New York University Center for Brain Health

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Butler Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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18F-AV-1451-A18

Identifier Type: -

Identifier Source: org_study_id

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