Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI and AD Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT02016560
First received: December 16, 2013
Last updated: January 27, 2016
Last verified: January 2016
  Purpose
This is a cross-sectional and longitudinal study that will evaluate imaging characteristics of 18F-AV-1451 in cognitively healthy volunteers, mild cognitive impairment (MCI) and Alzheimer's disease (AD) subjects.

Condition Intervention Phase
Alzheimer's Disease
Drug: florbetapir F 18
Drug: 18F-AV-1451
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: An Open Label, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-1451 in Cognitively Healthy Volunteers, Subjects With Mild Cognitive Impairment, and Subjects With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Cross-sectional 18F-AV-1451 Imaging Results [ Time Frame: 80-130 minutes post injection ] [ Designated as safety issue: No ]
    Compare standard uptake value ratio (SUVR) in subjects with AD to subjects with MCI and cognitively healthy older individuals.

  • Change in tau deposition over time [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Assess the rate of change of tau deposition as measured by 18F-AV-1451 uptake (SUVR) over time.


Secondary Outcome Measures:
  • 18F-AV-1451 imaging in healthy individuals [ Time Frame: 80-130 minutes post-injection ] [ Designated as safety issue: No ]
    Describe the tau SUVR distribution across age groups among cognitively healthy subjects.


Enrollment: 383
Study Start Date: December 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exploratory Cognitively Healthy Subjects
Subjects will receive an IV injection, 370 megabecquerel (MBq) (10 millicurie [mCi]), single dose of florbetapir F 18 at baseline. Cross-sectional and longitudinal subjects will receive an IV injection, 370 MBq (10 mCi), single dose of 18F-AV-1451 at baseline. Longitudinal subjects only will receive an IV injection, 370 MBq (10 mCi) of 18F-AV-1451 at 9 and 18 months.
Drug: florbetapir F 18
Other Names:
  • Amyvid
  • 18F-AV-45
Drug: 18F-AV-1451
Other Name: T807
Experimental: Exploratory MCI Subjects
Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of 18F-AV-1451 at baseline, 9 months and 18 months.
Drug: florbetapir F 18
Other Names:
  • Amyvid
  • 18F-AV-45
Drug: 18F-AV-1451
Other Name: T807
Experimental: Exploratory AD Subjects
Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of 18F-AV-1451 at baseline, 9 months and 18 months.
Drug: florbetapir F 18
Other Names:
  • Amyvid
  • 18F-AV-45
Drug: 18F-AV-1451
Other Name: T807
Experimental: Confirmatory Subjects
Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 and 18F-AV-1451 at baseline.
Drug: florbetapir F 18
Other Names:
  • Amyvid
  • 18F-AV-45
Drug: 18F-AV-1451
Other Name: T807

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Exploratory Cognitively Healthy Subjects

  • ≥ 20 to ≤ 40 years of age OR ≥ 50 years of age
  • Mini-mental state examination (MMSE) ≥ 29
  • No significant history of cognitive impairment

Exploratory MCI Subjects

  • ≥ 50 years of age
  • MMSE ≥ 24
  • Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) working group's diagnostic guidelines for AD
  • Have a study partner that can report on subject's activities of daily living

Exploratory AD Subjects

  • ≥ 50 years of age
  • MMSE > 10
  • Have possible or probable AD based on the NIA-AA working group's diagnostic guidelines for AD
  • Have a study partner that can report on subject's activities of daily living

Confirmatory Subjects

  • ≥ 50 years of age
  • MMSE ≥ 20 and ≤ 27
  • Cognitively impaired subjects with either MCI or dementia with a suspected neurodegenerative cause
  • Have a study partner that can report on subject's activities of daily living

Exclusion Criteria:

  • Current clinically significant psychiatric disease
  • Evidence of structural brain abnormalities
  • History of moderate or severe traumatic brain injury
  • 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
  • History of alcohol or substance abuse or dependence
  • Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
  • Have received or participated in a trial with investigational medications in the past 30 days
  • Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02016560

Locations
United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Four Peaks Neurology
Scottsdale, Arizona, United States, 85258
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, California
UC Irvine
Irvine, California, United States, 92697
Hoag Memorial
Newport Beach, California, United States, 92663
Norther California PET Imaging Center
Sacramento, California, United States, 95816
UC Davis
Sacramento, California, United States, 95817
UC San Francisco
San Francisco, California, United States, 94158
Neurological Research Institute
Santa Monica, California, United States, 90404
United States, Connecticut
Molecular NeuroImaging
New Haven, Connecticut, United States, 06510
United States, Florida
Quantum Laboratories
Deerfield Beach, Florida, United States, 33064
21st Century Oncology
Fort Myers, Florida, United States, 33912
Sandlake Imaging
Orlando, Florida, United States, 32806
Meridien Research
St. Petersburg, Florida, United States, 33709
USF Health Byrd Alzheimer's Center
Tampa, Florida, United States, 33613
Independent Imaging
West Palm Beach, Florida, United States, 33407
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston University
Boston, Massachusetts, United States, 02118
Alzheimer's Disease Center
Quincy, Massachusetts, United States, 02169
United States, Missouri
Center for Clinical Imaging Research
St. Louis, Missouri, United States, 63110
United States, Nevada
Las Vegas Radiology
Las Vegas, Nevada, United States, 89147
United States, New York
Center for Brain Health - NYU Langone Medical Center
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
  More Information

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02016560     History of Changes
Other Study ID Numbers: 18F-AV-1451-A05 
Study First Received: December 16, 2013
Last Updated: January 27, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 26, 2016