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| Name | Class |
|---|---|
| i3 Statprobe | INDUSTRY |
| Medpace, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (18F) Flutemetamol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F] Flutemetamol | Drug | Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | PET scans performed on patients 90 minutes post Flutemetmol Administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Sherwin, MD, PhD | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | (18F) Flutemetamol | [18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This is the number of participants that completed.
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| ID | Title | Description |
|---|---|---|
| BG000 | (18F) Flutemetamol | [18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Healthy young adult subjects aged 18 to 40 are presumed to be amyloid negative | Posted | Number | Brain Scans Read | PET scans performed on patients 90 minutes post Flutemetmol Administration |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | (18F) Flutemetamol | [18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Sherwin | GE Healthcare | 1-609-514-6820 | paulsherwin@ge.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C581552 | flutemetamol |
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| PET scans performed on patients 90 minutes post Flutemetmol Administration |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Standard Uptake Value Ratio ( SUVR) | PET scans performed on patients 90 minutes post Flutemetmol Administration |
|
|
|
| 0 |
| 181 |
| 27 |
| 181 |
| General Disorders and Administration Site Conditions | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vascular System Disorders | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vascular System Disorders-Flushing | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |