CompletedPhase 3

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

United States110 participantsStarted 2010-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity Analysis in All Autopsy Population

Timeframe: at autopsy within 24 months of florbetapir PET scan

Specificity Analysis in All Autopsy Population

Timeframe: at autopsy within 24 months of florbetapir PET scan

Correlation of Florbetapir-PET Image and Amyloid Plaque Density

Timeframe: at autopsy within 24 months of florbetapir PET scan

Trial details

NCT IDNCT01447719

SponsorAvid Radiopharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-03

Results submitted2012-04-06

View on ClinicalTrials.gov More Alzheimer's Disease trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Sensitivity Analysis in All Autopsy Population

Timeframe: at autopsy within 24 months of florbetapir PET scan

Specificity Analysis in All Autopsy Population

Timeframe: at autopsy within 24 months of florbetapir PET scan

Correlation of Florbetapir-PET Image and Amyloid Plaque Density

Timeframe: at autopsy within 24 months of florbetapir PET scan