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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
| i3 Statprobe | INDUSTRY |
| i3 Research | INDUSTRY |
| Quintiles, Inc. |
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This study will investigate the efficacy of the Flutemetamol (18F) Injection PET tracer in identifying abnormal (18F) flutemetamol uptake patterns which predict the conversion from aMCI to a b-amyloid associated clinically probable Alzheimer's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flutemetamol (18F) Injection | Experimental | Flutemetamol (18F) Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flutemetamol (18F) Injection | Drug | All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq. |
| Measure | Description | Time Frame |
|---|---|---|
| Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation. | Visual Interpretation of the PET scan by independent readers. Note: The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1. As the HR increases above 1, the chances of being probable Alzheimer's Disease (pAD) also increases. Note: Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 - 8 = 224 Subjects included). | Up to 36 months post flutemetamol administration |
| Measure | Description | Time Frame |
|---|---|---|
| The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. | Numbers of subjects with normal and abnormal patterns of [18F]flutemetamol uptake who converted to pAD. | Up to 36 months post flutemetamol administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Sherwin, M.D. | GE Healthcare | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35351181 | Derived | Pichet Binette A, Palmqvist S, Bali D, Farrar G, Buckley CJ, Wolk DA, Zetterberg H, Blennow K, Janelidze S, Hansson O. Combining plasma phospho-tau and accessible measures to evaluate progression to Alzheimer's dementia in mild cognitive impairment patients. Alzheimers Res Ther. 2022 Mar 29;14(1):46. doi: 10.1186/s13195-022-00990-0. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Flutemetamol (18F) Injection | Flutemetamol (18F) Injection: All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Flutemetamol (18F) Injection | Flutemetamol (18F) Injection: All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation. | Visual Interpretation of the PET scan by independent readers. Note: The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1. As the HR increases above 1, the chances of being probable Alzheimer's Disease (pAD) also increases. Note: Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 - 8 = 224 Subjects included). | Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 - 8 = 224 Subjects included). | Posted | Number | Ratio of visual interpretations | Up to 36 months post flutemetamol administration |
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| ||||||||||||||||||||||||||||||||||||
| Secondary | The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. | Numbers of subjects with normal and abnormal patterns of [18F]flutemetamol uptake who converted to pAD. | Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 - 8 = 224 Subjects included). | Posted | Number | Number of subjects | Up to 36 months post flutemetamol 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 | Flutemetamol (18F) Injection | Flutemetamol (18F) Injection: All subjects will receive an intravenous dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq. | 1 | 232 | 0 | 232 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactoid Reaction | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Sherwin M.D. | GE Healthcare | 16095146820 | Paul.Sherwin@ge.com |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D003147 | Communication Disorders |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C581552 | flutemetamol |
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| >=65 years |
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| Denmark |
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| Finland |
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| Sweden |
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| United Kingdom |
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| Title | Measurements |
|---|---|
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| Reader 4 - Visual Interpretation |
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| Reader 5 - Visual Interpretation |
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