Clinical trial NCT01447719: Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07
Official title: Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-10-06
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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:

1. 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).
2. 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.


Eligibility 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.

Primary outcomes:
measure: Sensitivity Analysis in All Autopsy Population
timeFrame: at autopsy within 24 months of florbetapir PET scan
measure: Specificity Analysis in All Autopsy Population
timeFrame: at autopsy within 24 months of florbetapir PET scan
measure: Correlation of Florbetapir-PET Image and Amyloid Plaque Density
timeFrame: at autopsy within 24 months of florbetapir PET scan
Secondary outcomes:
measure: Sensitivity Analysis in Subjects With Autopsy Within 1 Year of Scan
timeFrame: at autopsy within 12 months of florbetapir PET scan
measure: Specificity Analysis in Subjects With Autopsy Within 1 Year of Scan
timeFrame: at autopsy within 12 months of florbetapir PET scan
Other outcomes:
measure: Median Sensitivity and Specificity vs. CERAD Diagnosis
timeFrame: at autopsy within 24 months of florbetapir PET scan
measure: Individual Reader Results (All Scans With Autopsy)
timeFrame: at autopsy within 24 months of florbetapir PET scan
measure: Individual Reader Results (Autopsy Within 1 Year of Scan)
timeFrame: at autopsy within 12 months of florbetapir PET scan
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Sun City
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Irvine
country: United States
facility: Research Site
state: California
city: Fort Myers
country: United States
facility: Research Site
state: Florida
city: Miami Beach
country: United States
facility: Research Site
state: Florida
city: Miami Springs
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Saint Petersburg
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Hattiesburg
country: United States
facility: Research Site
state: Mississippi
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Albany
country: United States
facility: Research Site
state: New York
city: New Hyde Park
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Centerville
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Johnson City
country: United States
facility: Research Site
state: Tennessee
Study officials:
References:
citation: 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-beta plaques: a prospective cohort study. Lancet Neurol. 2012 Aug;11(8):669-78. doi: 10.1016/S1474-4422(12)70142-4. Epub 2012 Jun 28.