Healthy
Conditions
Keywords
Amyloid, Magnetic resonance imaging, Positron Emission Tomography, Standard uptake value ratios, Healthy Subjects
Brief summary
Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease (AD). The study drug helps produce pictures of amyloid in the brain. The purpose of this study is to determine how well the study drug performs in young healthy subjects.
Interventions
Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Sponsors
i3 Statprobe
Medpace, Inc.
GE Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* The subject age is 18 to 40 years. * The subject has no evidence of thinking or memory problems by medical history. * The subject has a normal MRI scan. * The subject's general health is adequate to comply with study procedures. * The subject is willing and able to participate in all study procedures.
Exclusion criteria
* The subject has received any medical ionizing radiation exposure in the last 12 months (except planar x-ray or head CT). * The subject has a contraindication for (cannot undergo) MRI. * The subject has a history of head injury with loss of consciousness. * The subject has any significant medical, psychiatric or neurological condition that might be associated with brain pathology. * The subject has a family history of Alzheimer's Disease (AD); more than 1 first-degree relative.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid | PET scans performed on patients 90 minutes post Flutemetmol Administration | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Amyloid Content in Different Parts of the Brain | PET scans performed on patients 90 minutes post Flutemetmol Administration | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| (18F) Flutemetamol \[18F\] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection. | 181 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Subjects withdrawn | 37 |
Baseline characteristics
| Characteristic | (18F) Flutemetamol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 181 Participants |
| Age Continuous | 29 years STANDARD_DEVIATION 5.9 |
| Region of Enrollment Belgium | 10 participants |
| Region of Enrollment Finland | 19 participants |
| Region of Enrollment United Kingdom | 25 participants |
| Region of Enrollment United States | 127 participants |
| Sex: Female, Male Female | 103 Participants |
| Sex: Female, Male Male | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 181 |
| serious Total, serious adverse events | 0 / 181 |
Outcome results
Primary
Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid
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).
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Normal and Abnormal Reads With or Without Amyloid | Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid | Reader 1 -Normal Read-no amyloid | 181 Brain Scans Read |
| Normal and Abnormal Reads With or Without Amyloid | 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 |
| Normal and Abnormal Reads With or Without Amyloid | Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid | Reader 2 - Normal Read-no amyloid | 123 Brain Scans Read |
| Normal and Abnormal Reads With or Without Amyloid | 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 |
| Normal and Abnormal Reads With or Without Amyloid | Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid | Reader 3 - Normal Read-no amyloid | 180 Brain Scans Read |
| Normal and Abnormal Reads With or Without Amyloid | 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 |
| Normal and Abnormal Reads With or Without Amyloid | Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid | Reader 4 - Normal Read-no amyloid | 180 Brain Scans Read |
| Normal and Abnormal Reads With or Without Amyloid | 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 |
| Normal and Abnormal Reads With or Without Amyloid | Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid | Reader 5 - Normal Read-no amyloid | 179 Brain Scans Read |
| Normal and Abnormal Reads With or Without Amyloid | 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
Measurement of Amyloid Content in Different Parts of the Brain
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal and Abnormal Reads With or Without Amyloid | Measurement of Amyloid Content in Different Parts of the Brain | Cerebullum Region | 1.12 Standard Uptake Value Ratio ( SUVR) | Standard Deviation 0.097 |
| Normal and Abnormal Reads With or Without Amyloid | Measurement of Amyloid Content in Different Parts of the Brain | Pons Region | 0.49 Standard Uptake Value Ratio ( SUVR) | Standard Deviation 0.036 |