Trial record 6 of 64 for:    avid

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Avid Radiopharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT02051764
First received: January 30, 2014
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

This study will evaluate the imaging characteristics of 18F-AV-1451 in subjects with a previous 18F-AV-1451 scan in order to assess the rate of change of tau deposition over time.


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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Who Have Had a Prior 18F-AV-1451 Scan

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Change in Tau deposition [ Time Frame: At least 6 months after initial 18F-AV-1451 scan ] [ Designated as safety issue: No ]
    To assess the rate of change of tau deposition as measured by 18F-AV-1451 standard uptake value ratio (SUVr) over time.


Estimated Enrollment: 200
Study Start Date: May 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Previous 18F-AV-1451 Scan
Subjects with a previous 18F-AV-1451 scan will receive an IV injection, 370 megabecquerel (MBq) (10 millicurie [mCi]), single dose of 18F-AV-1451. Subjects with an unknown amyloid status will receive an IV injection, 370 megabecquerel (MBq) (10 millicurie [mCi]), single dose of florbetapir F 18.
Drug: 18F-AV-1451
Other Name: [F-18]T807
Drug: Florbetapir F 18
Other Names:
  • Amyvid
  • 18F-AV-45

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT02051764

Contacts
Contact: Avid Clinical Operations 215-298-0700 clinicaloperations@avidrp.com

Locations
United States, California
Research Site Completed
Newport Beach, California, United States, 92663
Research Site Recruiting
Orange, California, United States, 92868
United States, Massachusetts
Research Site Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Chair: Chief Medical Officer Avid Radiopharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02051764     History of Changes
Other Study ID Numbers: 18F-AV-1451-A04
Study First Received: January 30, 2014
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014