Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07

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.

ClinicalTrials.gov Identifier: NCT01447719

Recruitment Status : Completed

First Posted : October 6, 2011

Results First Posted : May 7, 2012

Last Update Posted : May 22, 2012

Sponsor:

Information provided by (Responsible Party):

Avid Radiopharmaceuticals

Study Description

Brief Summary:

This study is designed to test the relationship between measurements of brain amyloid using florbetapir F 18 PET imaging and true levels of amyloid plaque density as measured by histopathological assessment. The study will address the following specific aims:

To expand the number of subjects included in the A07 (NCT00857415) trial correlation analysis (measuring the correlation between the global visual rating of brain amyloid plaque density on an independent blinded read of the florbetapir F 18 PET scan and the cortical amyloid plaque density at autopsy as assessed by histopathology for subjects in the autopsy cohort).
To determine the sensitivity and specificity of an independent blinded visual read assessment of the florbetapir F 18 PET scan (Aβ+ or Aβ-) versus the final blinded neuropathological assessment made at autopsy.

Condition or disease	Intervention/treatment	Phase
Alzheimer's Disease	Drug: florbetapir F 18	Phase 3

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	110 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07
Study Start Date :	March 2010
Actual Primary Completion Date :	March 2011
Actual Study Completion Date :	July 2011

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Alzheimer disease

Drug Information available for: Florbetapir F-18

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Arms and Interventions

Intervention Details:

Drug: florbetapir F 18
No study drug administered in this trial. Study subjects previously dosed with 18F-AV-45 in study 18F-AV-45-A07 (NCT00857415) are followed to autopsy in this extension study.
Other Names:
- 18F-AV-45
- Amyvid
- florbetapir

Outcome Measures

Primary Outcome Measures :

Sensitivity Analysis in All Autopsy Population [ Time Frame: at autopsy within 24 months of florbetapir PET scan ]
Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD (Consortium to Establish a Registry for AD) criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).
Specificity Analysis in All Autopsy Population [ Time Frame: at autopsy within 24 months of florbetapir PET scan ]
Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).
Correlation of Florbetapir-PET Image and Amyloid Plaque Density [ Time Frame: at autopsy within 24 months of florbetapir PET scan ]
Spearman's rank order correlation of the median visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.

Secondary Outcome Measures :

Sensitivity Analysis in Subjects With Autopsy Within 1 Year of Scan [ Time Frame: at autopsy within 12 months of florbetapir PET scan ]
Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).
Specificity Analysis in Subjects With Autopsy Within 1 Year of Scan [ Time Frame: at autopsy within 12 months of florbetapir PET scan ]
Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).

Other Outcome Measures:

Median Sensitivity and Specificity vs. CERAD Diagnosis [ Time Frame: at autopsy within 24 months of florbetapir PET scan ]
Median sensitivity and specificity for 5 independent readers to detect moderate to frequent amyloid plaques (per CERAD criteria).
Individual Reader Results (All Scans With Autopsy) [ Time Frame: at autopsy within 24 months of florbetapir PET scan ]
Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 39 positive and 20 negative scans based on histopathology at autopsy.
Individual Reader Results (Autopsy Within 1 Year of Scan) [ Time Frame: at autopsy within 12 months of florbetapir PET scan ]
Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 28 positive and 18 negative scans based on histopathology at autopsy.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects are enrolled in this study if they:

Met entrance criteria and were enrolled and imaged in trial 18F-AV-45-A07 (NCT00857415)
Gave informed consent for the 18F-AV-45-A07 (NCT00857415) study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die
Consent to participate in the 18F-AV-45-A16 (NCT01447719) extension protocol, if required by the IRB
Reconfirm their consent to a research brain autopsy, if required by the IRB.

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01447719

Locations

Layout table for location information

United States, Arizona
Research Site
Phoeniz, Arizona, United States, 85006
Research Site
Sun City, Arizona, United States, 85351
United States, Arkansas
Research Site
Little Rock, Arkansas, United States, 72211
United States, California
Research Site
Irvine, California, United States, 92697
United States, Florida
Research Site
Fort Myers, Florida, United States, 33912
Research Site
Miami Beach, Florida, United States, 33140
Research Site
Miami Springs, Florida, United States, 33166
Research Site
Miami, Florida, United States, 33137
Research Site
Orlando, Florida, United States, 32835
Research Site
Sarasota, Florida, United States, 34231
Research Site
St. Petersburg, Florida, United States, 33709
Research Site
West Palm Beach, Florida, United States, 33407
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21221
United States, Mississippi
Research Site
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Research Site
St. Louis, Missouri, United States, 63141
United States, New York
Research Site
Albany, New York, United States, 12208
Research Site
New Hyde Park, New York, United States, 11040
United States, North Carolina
Research Site
Durham, North Carolina, United States, 27710
United States, Ohio
Research Site
Centerville, Ohio, United States, 45459
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73112
United States, South Carolina
Research Site
Charleston, South Carolina, United States, 29425
United States, Tennessee
Research Site
Johnson City, Tennessee, United States, 37614

Sponsors and Collaborators

Avid Radiopharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Clark CM, Pontecorvo MJ, Beach TG, Bedell BJ, Coleman RE, Doraiswamy PM, Fleisher AS, Reiman EM, Sabbagh MN, Sadowsky CH, Schneider JA, Arora A, Carpenter AP, Flitter ML, Joshi AD, Krautkramer MJ, Lu M, Mintun MA, Skovronsky DM; AV-45-A16 Study Group. Cerebral PET with florbetapir compared with neuropathology at autopsy for detection of neuritic amyloid-β plaques: a prospective cohort study. Lancet Neurol. 2012 Aug;11(8):669-78. Epub 2012 Jun 28. Erratum in: Lancet Neurol. 2012 Aug;11(8):658.

Layout table for additonal information

Responsible Party:	Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:	NCT01447719
Other Study ID Numbers:	18F-AV-45-A16
First Posted:	October 6, 2011 Key Record Dates
Results First Posted:	May 7, 2012
Last Update Posted:	May 22, 2012
Last Verified:	May 2012

Additional relevant MeSH terms:

Layout table for MeSH terms

Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases	Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders

To Top