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

This study has been completed.
Sponsor:
Collaborators:
American College of Radiology Imaging Network
General Electric
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00855868
First received: March 2, 2009
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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.

SPECIFIC HYPOTHESES

  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 Intervention Phase
Alzheimer's Disease
Drug: florbetapir F 18
Drug: [11C]-PIB
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 28
Study Start Date: March 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00855868

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

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT00855868     History of Changes
Other Study ID Numbers: ACRIN PA 4003
Study First Received: March 2, 2009
Results First Received: May 4, 2012
Last Updated: June 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Avid Radiopharmaceuticals:
Amyloid imaging
Positron Emission Tomography
18F-AV-45
florbetapir F 18
Diagnostic imaging

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 August 26, 2014