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

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ClinicalTrials.gov Identifier: NCT02795780
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Brief Summary:
This study will evaluate longitudinal change of tau deposition as measured by 18F-AV-1451 uptake over time.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: 18F-AV-1451 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Open Label, Multicenter Study Evaluating the Imaging Characteristics of a Follow up 18F-AV-1451 Scan in Subjects That Participated in the Confirmatory Cohort of 18F-AV-1451-A05
Study Start Date : August 2016
Actual Primary Completion Date : August 28, 2017
Actual Study Completion Date : August 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Experimental: A05 Confirmatory Cohort
Subjects from the 18F-AV-1451-A05 (NCT02016560) confirmatory cohort who have completed the 18F-AV-1451-A05 study and consented to participate in the 18F-AV-1451-A18 study. Subjects will receive an IV injection, 370 megabecquerel (MBq) (10 millicurie [mCi]), single dose of 18F-AV-1451.
Drug: 18F-AV-1451
Other Name: T807




Primary Outcome Measures :
  1. Change in tau deposition over time [ Time Frame: baseline and 19 months ]
    Assess the change in tau deposition as measured by 18F-AV-1451 standard uptake value ratio (SUVR) from the baseline scan in study 18F-AV-1451-A05 (NCT02016560) to the follow up scan in study 18F-AV-1451-A18.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 know 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795780


Locations
United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Imaging Endpoints
Scottsdale, Arizona, United States, 85258
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, California
Institute for Brain Aging and Dementia, UC Irvine
Irvine, California, United States, 92697
21st Century Oncology
Newport Beach, California, United States, 92663
Alzheimer's Disease Center, UC Davis
Sacramento, California, United States, 95817
California Medical Clinic for Headache
Santa Monica, California, United States, 90404
United States, Florida
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States, 33912
Compass Research, LLC
Orlando, Florida, United States, 32806
Meridien Research
Saint Petersburg, Florida, United States, 33709
University of South Florida Health Byrd Alzheimer's Institute
Tampa, Florida, United States, 33613
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nevada
Las Vegas Radiology
Las Vegas, Nevada, United States, 89113
United States, New York
New York University Center for Brain Health
New York, New York, United States, 10016
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Avid Radiopharmaceuticals

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02795780     History of Changes
Other Study ID Numbers: 18F-AV-1451-A18
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders