Trial record 8 of 63 for:    avid

Florbetapir Calibration to the Centiloid Scale

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Avid Radiopharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT02120664
First received: April 17, 2014
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.


Condition Intervention Phase
Alzheimer's Disease
Drug: Florbetapir (18F)
Drug: 11C-PiB
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Multicenter, Multicountry Study to Calibrate Florbetapir (18F) PET Imaging Data to the Centiloid Scale Based on 11C-PiB

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Florbetapir SUVr Conversion to Centiloid Units [ Time Frame: up to 70 minutes post injection ] [ Designated as safety issue: No ]
    Conversion of florbetapir (18F) PET SUVr to Centiloid units


Secondary Outcome Measures:
  • Correlation of florbetapir (18F) centiloid and 11C-PiB centiloid [ Time Frame: up to 70 minutes post injection ] [ Designated as safety issue: No ]
    Spearman rank correlation analysis between 11C-PiB and florbetapir (18F) SUVr as converted to centiloid units.

  • Variability of PET Images in Control Subjects. [ Time Frame: up to 70 minutes post injection ] [ Designated as safety issue: No ]
    Variance and coefficient of variation for 11C-PiB and florbetapir (18F) SUVr.


Estimated Enrollment: 35
Study Start Date: April 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amyloid Negative Subjects
Approximately 10 cognitively normal young subjects will receive a single i.v. bolus injection of approximately 370 megabecquerel (MBq) (10 millicurie [mCi]) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.
Drug: Florbetapir (18F)
Other Names:
  • Florbetapir F 18
  • Amyvid
  • 18F-AV-45
Drug: 11C-PiB
Other Name: Pittsburgh Compound B
Experimental: Amyloid Positive Subjects
Approximately 25 subjects with a range of amyloid density comprised of subjects clinically diagnosed with Alzheimer's Disease (AD) and subjects at risk for elevated amyloid density will receive a single i.v. bolus injection of approximately 370 MBq (10 mCi) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.
Drug: Florbetapir (18F)
Other Names:
  • Florbetapir F 18
  • Amyvid
  • 18F-AV-45
Drug: 11C-PiB
Other Name: Pittsburgh Compound B

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cognitively Normal Subjects

    • Males or females ≥ 21 and ≤ 45 years of age
    • Mini-mental state examination (MMSE) ≥ 29
  • Clinically Diagnosed AD Subject

    • Males or females ≥ 50 years of age
    • Meet clinical criteria for dementia due to probable AD
    • MMSE ≥ 16 and ≤ 26
  • Possible AD Subject

    • Males or females ≥ 50 years of age
    • Meet clinical criteria for dementia due to possible AD
    • MMSE ≥ 16 and ≤ 26
  • MCI Subject

    • Males or females ≥ 60 years of age with cognitive impairment (not dementia)
    • MMSE >24 and <29
  • At Risk Elderly Subject

    • Cognitively normal males or females that are known ApoE4 carriers and ≥ 75 years of age
    • MMSE ≥ 27

Exclusion Criteria:

  • Have had or currently have a diagnosis of neurodegenerative disorders other than AD
  • Have a current serious or unstable illness that could interfere with completion of the study
  • Subject has a known brain lesion, pathology or traumatic brain injury
  • Have received or participated in a trial with investigational medications in the past 30 days
  • Have had a radiopharmaceutical imaging or treatment procedure within 7 days of study imaging session
  • Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
  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: NCT02120664

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

Locations
United States, Pennsylvania
Research Site Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Australia, Victoria
Research Site Recruiting
Heidelberg, Victoria, Australia, 3084
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: NCT02120664     History of Changes
Other Study ID Numbers: 18F-AV-45-A22
Study First Received: April 17, 2014
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods 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 July 22, 2014