Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00855868
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : July 26, 2012
Last Update Posted : July 26, 2012
American College of Radiology Imaging Network
General Electric
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Brief Summary:

This study will evaluate the performance characteristics of a novel [18F] amyloid detection ligand (18F]-AV-45) with respect to its ability to distinguish patients with clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects and to independently compare its diagnostic performance characteristics with the ability of [11C]PIB to correctly categorize the same subjects.


  1. Individuals with a clinical diagnosis of probable Alzheimer's disease will have increased brain retention of [18F]-AV-45 compared to cognitively normal elderly individuals.
  2. There will be no clinically meaningful difference in the amyloid retention performance characteristics of [18F]-AV-45 and [l1C]PIB.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: florbetapir F 18 Drug: [11C]-PIB Phase 2

Detailed Description:
15 patients with a clinical diagnosis of probable Alzheimer's disease and 15 cognitively normal elderly control subjects will receive both [18F]-AV-45 and [11C]PIB to compare the diagnostic performance characteristics of each amyloid ligand to distinguish AD from normal subjects. In addition to clinical diagnostic category, ligand retention will be evaluated with respect to measures of symptom severity and cerebrospinal fluid levels of amyloid and tau.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Ability of a Novel [18F] Amyloid Ligand ([18F]-AV-45) to Distinguish Patients With a Clinical Diagnosis of Alzheimer's Disease From Cognitively Normal Elderly Individuals
Study Start Date : March 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Intervention Details:
  • Drug: florbetapir F 18
    370 MBq (10 mCi), intravenous (IV) injection, single dose
    Other Names:
    • 18F-AV-45
    • Amyvid
    • florbetapir
  • Drug: [11C]-PIB
    555 MBq (15 mCi), IV injection, single dose [11C]-PIB
    Other Name: C-11 PIB

Primary Outcome Measures :
  1. Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects. [ Time Frame: 28 d ]
    Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Normal subjects: mini-mental state examination (MMSE) 27-30, clinical dementia rating (CDR) = 0, no symptoms of depression
  • Alzheimer's subjects: MMSE 18-26, CDR >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI

Exclusion Criteria:

  • other neurological disease
  • evidence of MRI abnormality
  • psychiatric disorder
  • alcohol abuse
  • clinically significant lab abnormalities
  • residence in nursing facility
  • participation in clinical trial with experimental medication in past 1 month

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 identifier (NCT number): NCT00855868

United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Avid Radiopharmaceuticals
American College of Radiology Imaging Network
General Electric
Study Director: Chief Medical Officer Avid Radiopharmaceuticals

Responsible Party: Avid Radiopharmaceuticals Identifier: NCT00855868     History of Changes
Other Study ID Numbers: ACRIN PA 4003
First Posted: March 5, 2009    Key Record Dates
Results First Posted: July 26, 2012
Last Update Posted: July 26, 2012
Last Verified: June 2012

Keywords provided by Avid Radiopharmaceuticals:
Amyloid imaging
Positron Emission Tomography
florbetapir F 18
Diagnostic imaging

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