Trial Outcomes & Findings for Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels (NCT NCT01165554)

Results Overview

A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader "N") divided by the (Total number of abnormal participants). Blinded visual interpretations of \[18F\]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

203 participants

Primary outcome timeframe

Post flutemetamol administration.

Results posted on

2013-12-04

Participant Flow

Study started on May, 2010 and ended on November 2011.

23 subjects withdrew from study prior to dosing of the product.

Participant milestones

Participant milestones
Measure	Flutemetamol Injection \[18F\]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol was 185 to 370 megabecquerels (MBq).
Overall Study STARTED	203
Overall Study COMPLETED	180
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Flutemetamol Injection \[18F\]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol was 185 to 370 megabecquerels (MBq).
Overall Study Withdrawal by Subject	23

Baseline Characteristics

Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flutemetamol Injection n=180 Participants \[18F\]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol was 185 to 370 megabecquerels (MBq).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	165 Participants n=5 Participants
Age Continuous	79.9 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants
Sex: Female, Male Male	77 Participants n=5 Participants
Region of Enrollment United States	168 participants n=5 Participants
Region of Enrollment United Kingdom	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Post flutemetamol administration.

Population: The assessments were post-mortum based on the estimates of the presence of amyloid plaque in the brain.

A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader "N") divided by the (Total number of abnormal participants). Blinded visual interpretations of \[18F\]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β.

Outcome measures

Outcome measures
Measure	Sensitivity Percentage of Abnormal Visual Reads n=43 Participants
The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β. Reader 5 - Abnormal	88 Percentage of Sensitivity by Reader
The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β. Reader 1- Abnormal	81 Percentage of Sensitivity by Reader
The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β. Reader 2 - Abnormal	88 Percentage of Sensitivity by Reader
The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β. Reader 3 - Abnormal	93 Percentage of Sensitivity by Reader
The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β. Reader 4 - Abnormal	93 Percentage of Sensitivity by Reader

SECONDARY outcome

Timeframe: Post Flutemetamol administrations

Population: The assessment was done post-mortum based on the estimates of the presence of amyloid plaque in the brain.

A calculation used to assess Specificity was (Number of Blinded Reads determined normal by Reader "N") divided by the (Total number of normal participants). Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, without anatomic brain images.

Outcome measures

Outcome measures
Measure	Sensitivity Percentage of Abnormal Visual Reads n=25 Participants
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images. Reader 1 - Normal	88 Percentage of Specificity by Reader
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images. Reader 2 - Normal	92 Percentage of Specificity by Reader
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images. Reader 3 - Normal	44 Percentage of Specificity by Reader
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images. Reader 4 - Normal	80 Percentage of Specificity by Reader
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images. Reader 5 - Normal	92 Percentage of Specificity by Reader

SECONDARY outcome

Timeframe: Post flutemetamol administration.

Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as abnormal, with anatomic CT brain images for reference.

Outcome measures

Outcome measures
Measure	Sensitivity Percentage of Abnormal Visual Reads n=43 Participants
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference. Reader 1	91 Percent of Sensitivity-Abnormal Reads Interval 78.0 to 97.0
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference. Reader 2	95 Percent of Sensitivity-Abnormal Reads Interval 84.0 to 99.0
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference. Reader 3	98 Percent of Sensitivity-Abnormal Reads Interval 88.0 to 100.0
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference. Reader 4	91 Percent of Sensitivity-Abnormal Reads Interval 78.0 to 97.0
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference. Reader 5	91 Percent of Sensitivity-Abnormal Reads Interval 77.0 to 97.0

SECONDARY outcome

Timeframe: Post flutemetamol administration.

Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, with anatomic CT brain images for reference.

Outcome measures

Outcome measures
Measure	Sensitivity Percentage of Abnormal Visual Reads n=25 Participants
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference. Reader 1	92 Percent of Specificity-Normal Reads Interval 74.0 to 99.0
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference. Reader 2	88 Percent of Specificity-Normal Reads Interval 69.0 to 98.0
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference. Reader 3	56 Percent of Specificity-Normal Reads Interval 35.0 to 76.0
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference. Reader 4	88 Percent of Specificity-Normal Reads Interval 69.0 to 98.0
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference. Reader 5	92 Percent of Specificity-Normal Reads Interval 74.0 to 99.0

Adverse Events

Flutemetamol Injection

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Flutemetamol Injection n=180 participants at risk \[18F\]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol was 185 to 370 megabecquerels (MBq).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.56% 1/180 • Number of events 1
Blood and lymphatic system disorders Anemia	0.56% 1/180 • Number of events 1
Psychiatric disorders Senile Dementia	0.56% 1/180 • Number of events 1
Psychiatric disorders Change in Mental Status	0.56% 1/180 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paul Sherwin

GE Healthcare

Phone: 1-609-514-6820

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place