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

Avid Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: florbetapir F 18

Study type: Interventional

Funder types: Industry

Identifiers

NCT01447719

18F-AV-45-A16

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)