Trial Outcomes & Findings for Re-Read Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Neuritic Plaque Density Determined Postmortem (NCT NCT02090855)

Results Overview

Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of \[18F\]flutemetamol PET images through an electronic training program.

Recruitment status

COMPLETED

Target enrollment

108 participants

Primary outcome timeframe

Brain images will be assessed up to 1 year post subject's death.

Results posted on

2017-03-27

Participant Flow

This study is to assess the images taken previously from another study, GE-067-007. No drug was administered. Subjects were previously dosed in Study GE-067-007.

Participant milestones

Participant milestones
Measure	Flutemetamol (18F) There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. No drug was administered. Subjects were previously dosed in Study GE-067-007.
Overall Study STARTED	108
Overall Study COMPLETED	106
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Flutemetamol (18F) There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. No drug was administered. Subjects were previously dosed in Study GE-067-007.
Overall Study no evaluable Standard of Truth results	2

Baseline Characteristics

Re-Read Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Neuritic Plaque Density Determined Postmortem

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flutemetamol (18F) n=106 Participants There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. No drug was administered.
Age, Continuous	80.8 years STANDARD_DEVIATION 8.87 • n=93 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants
Age, Categorical >=65 years	98 Participants n=93 Participants
Sex: Female, Male Female	58 Participants n=93 Participants
Sex: Female, Male Male	48 Participants n=93 Participants
Region of Enrollment United States	102 participants n=93 Participants
Region of Enrollment United Kingdom	4 participants n=93 Participants

PRIMARY outcome

Timeframe: Brain images will be assessed up to 1 year post subject's death.

Population: There are 76 autopsy cases confirmed to be abnormal. The majority interpretation is the interpretation made independently by more than half of the readers.

Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of \[18F\]flutemetamol PET images through an electronic training program.

Outcome measures

Outcome measures
Measure	Standard of Truth (SoT) n=76 Participants Each Reader will have a total of 76 image interpretations when combining normal and abnormal readings.The Standard of Truth is based on moderate/frequent neuritic (amyloid) plaques, per modified Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria, based on specimens stained with the Bielschowsky silver stain.
The Number of Abnormal Blinded Visual PET Image Interpretations. Reader 3-Blinded Visual--Abnormal Interpretation	67 Number of Blinded Image Interpretations Interval 78.7 to 94.4
The Number of Abnormal Blinded Visual PET Image Interpretations. Reader 4-Blinded Visual--Abnormal Interpretation	67 Number of Blinded Image Interpretations Interval 78.7 to 94.4
The Number of Abnormal Blinded Visual PET Image Interpretations. Reader 5-Blinded Visual--Abnormal Interpretation	72 Number of Blinded Image Interpretations Interval 87.1 to 98.5
The Number of Abnormal Blinded Visual PET Image Interpretations. Majority Read-Abnormal	69 Number of Blinded Image Interpretations Interval 81.9 to 96.2
The Number of Abnormal Blinded Visual PET Image Interpretations. Reader 1-Blinded Visual--Abnormal Interpretation	73 Number of Blinded Image Interpretations Interval 88.9 to 99.2
The Number of Abnormal Blinded Visual PET Image Interpretations. Reader 2-Blinded Visual--Abnormal Interpretation	68 Number of Blinded Image Interpretations Interval 80.3 to 95.3

PRIMARY outcome

Timeframe: Brain images will be assessed up to 1 year post subject's death.

Population: There are 76 autopsy cases confirmed to be abnormal. The majority interpretation is the interpretation made independently by more than half of the readers.

Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of \[18F\]flutemetamol PET images through an electronic training program.

Outcome measures

Outcome measures
Measure	Standard of Truth (SoT) n=76 Participants Each Reader will have a total of 76 image interpretations when combining normal and abnormal readings.The Standard of Truth is based on moderate/frequent neuritic (amyloid) plaques, per modified Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria, based on specimens stained with the Bielschowsky silver stain.
Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans Reader 1-Blinded Visual--Abnormal Interpretation	96.1 Percent of Sensitivity
Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans Reader 2-Blinded Visual--Abnormal Interpretation	89.5 Percent of Sensitivity
Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans Reader 3-Blinded Visual--Abnormal Interpretation	88.2 Percent of Sensitivity
Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans Reader 4-Blinded Visual--Abnormal Interpretation	88.2 Percent of Sensitivity
Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans Reader 5-Blinded Visual--Abnormal Interpretation	94.7 Percent of Sensitivity
Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans Majority Read-Abnormal	90.8 Percent of Sensitivity

SECONDARY outcome

Timeframe: Brain images will be assessed up to 1 year post subject's death.

Population: There are 30 autopsy cases confirmed to be normal. The majority interpretation is the interpretation made independently by more than half of the readers.

Specificity of blinded visual image interpretations according to neuropathological criteria.

Outcome measures

Outcome measures
Measure	Standard of Truth (SoT) n=30 Participants Each Reader will have a total of 76 image interpretations when combining normal and abnormal readings.The Standard of Truth is based on moderate/frequent neuritic (amyloid) plaques, per modified Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria, based on specimens stained with the Bielschowsky silver stain.
Number of Blinded Visual PET Image Interpretations Reader 1-Blinded Visual-Normal Interpretation	25 Number of Blinded Image Intrepretations
Number of Blinded Visual PET Image Interpretations Reader 3-Blinded Visual-Normal Interpretation	28 Number of Blinded Image Intrepretations
Number of Blinded Visual PET Image Interpretations Reader 4-Blinded Visual-Normal Interpretation	25 Number of Blinded Image Intrepretations
Number of Blinded Visual PET Image Interpretations Reader 5-Blinded Visual-Normal Interpretation	26 Number of Blinded Image Intrepretations
Number of Blinded Visual PET Image Interpretations Majority Read-Normal	27 Number of Blinded Image Intrepretations
Number of Blinded Visual PET Image Interpretations Reader 2-Blinded Visual-Normal Interpretation	27 Number of Blinded Image Intrepretations

SECONDARY outcome

Timeframe: Brain images will be assessed up to 1 year post subject's death.

Population: There are 30 autopsy cases confirmed to be normal. The majority interpretation is the interpretation made independently by more than half of the readers.

Specificity of blinded visual image interpretations according to neuropathological criteria, which is defined as the neuritic plaque density, neurofibriilary tangles and vasculpoathy in the brain.

Outcome measures

Outcome measures
Measure	Standard of Truth (SoT) n=30 Participants Each Reader will have a total of 76 image interpretations when combining normal and abnormal readings.The Standard of Truth is based on moderate/frequent neuritic (amyloid) plaques, per modified Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria, based on specimens stained with the Bielschowsky silver stain.
Specificity Percentage of Blinded Visual PET Image Interpretations Reader 1-Blinded Visual-Normal Interpretation	83.3 Percentage of Specificity
Specificity Percentage of Blinded Visual PET Image Interpretations Reader 2-Blinded Visual-Normal Interpretation	90.0 Percentage of Specificity
Specificity Percentage of Blinded Visual PET Image Interpretations Reader 3-Blinded Visual-Normal Interpretation	93.3 Percentage of Specificity
Specificity Percentage of Blinded Visual PET Image Interpretations Reader 4-Blinded Visual-Normal Interpretation	83.3 Percentage of Specificity
Specificity Percentage of Blinded Visual PET Image Interpretations Reader 5-Blinded Visual-Normal Interpretation	86.7 Percentage of Specificity
Specificity Percentage of Blinded Visual PET Image Interpretations Majority Read-Normal	90.0 Percentage of Specificity

Adverse Events

Flutemetamol (18F)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul Sherwin, M.D.

GE Healthcare

Phone: 1-609-514-6489

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place