Trial Outcomes & Findings for Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects (NCT NCT01265394)

Last Updated: 2013-07-02

Results Overview

The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging. The measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

218 participants

Primary outcome timeframe

PET scans performed on patients 90 minutes post Flutemetmol Administration

Results posted on

2013-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	(18F) Flutemetamol \[18F\] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Overall Study STARTED	218
Overall Study COMPLETED	181
Overall Study NOT COMPLETED	37

Reasons for withdrawal

Reasons for withdrawal
Measure	(18F) Flutemetamol \[18F\] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Overall Study Subjects withdrawn	37

Baseline Characteristics

Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	(18F) Flutemetamol n=181 Participants \[18F\] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	181 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	29 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants
Region of Enrollment United States	127 participants n=5 Participants
Region of Enrollment Belgium	10 participants n=5 Participants
Region of Enrollment Finland	19 participants n=5 Participants
Region of Enrollment United Kingdom	25 participants n=5 Participants

PRIMARY outcome

Timeframe: PET scans performed on patients 90 minutes post Flutemetmol Administration

Population: Healthy young adult subjects aged 18 to 40 are presumed to be amyloid negative

Outcome measures

Outcome measures
Measure	Normal and Abnormal Reads With or Without Amyloid n=181 Participants Each Subject received a dose of \[18F\] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid Reader 1 -Normal Read-no amyloid	181 Brain Scans Read Interval 98.0 to 100.0
Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid Reader 1- Abnormal Read- amyloid is present	0 Brain Scans Read Interval 60.6 to 74.7
Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid Reader 2 - Normal Read-no amyloid	123 Brain Scans Read Interval 97.0 to 100.0
Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid Reader 2 - Abnormal Read-amyloid is present	58 Brain Scans Read Interval 97.0 to 100.0
Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid Reader 3 - Normal Read-no amyloid	180 Brain Scans Read Interval 96.1 to 99.9
Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid Reader 3 - Abnormal Read-amyloid is present	1 Brain Scans Read
Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid Reader 4 - Normal Read-no amyloid	180 Brain Scans Read
Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid Reader 4 - Abnormal Read-amyloid is present	1 Brain Scans Read
Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid Reader 5 - Normal Read-no amyloid	179 Brain Scans Read
Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid Reader 5 - Abnormal Read-amyloid is present	2 Brain Scans Read

SECONDARY outcome

Timeframe: PET scans performed on patients 90 minutes post Flutemetmol Administration

Population: The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements.

Is the computerized measurement of amyloid content in different parts of the brain. The Standard Uptake Value Ratio (SUVR) is defined as an average of frontal, anterior cingulate, pariteal, lateral-temporal and posterior cingulate / precuneous uptake following administration of Flutemetamol F18 Injection. The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements.

Outcome measures

Outcome measures
Measure	Normal and Abnormal Reads With or Without Amyloid n=181 Participants Each Subject received a dose of \[18F\] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Measurement of Amyloid Content in Different Parts of the Brain Pons Region	0.49 Standard Uptake Value Ratio ( SUVR) Standard Deviation 0.036 • Interval 0.487 to 0.498
Measurement of Amyloid Content in Different Parts of the Brain Cerebullum Region	1.12 Standard Uptake Value Ratio ( SUVR) Standard Deviation 0.097 • Interval 1.108 to 1.136

Adverse Events

(18F) Flutemetamol

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	(18F) Flutemetamol n=181 participants at risk \[18F\] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Gastrointestinal disorders Gastrointestinal disorders	5.0% 9/181 • Number of events 9
General disorders General Disorders and Administration Site Conditions	6.6% 12/181 • Number of events 12
Vascular disorders Vascular System Disorders	6.1% 11/181 • Number of events 11
Vascular disorders Vascular System Disorders-Flushing	5.5% 10/181 • Number of events 10

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