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Study 18F-AV-45-010 is designed to evaluate the cerebral uptake of florbetapir 18F as measured by PET imaging in frontotemporal disorder (FTD) in comparison to cognitively normal volunteers and subjects with Alzheimer's disease (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frontotemporal Disorder | Experimental | Subjects with frontotemporal disorder (FTD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F and a one-time IV bolus injection of 185 MBq of 18F-FDG. |
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| Cognitively Normal | Experimental | Cognitively normal (CN) subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. |
|
| Alzheimer's Disease | Experimental | Subjects with Alzheimer's disease (AD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| florbetapir 18F | Drug | Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. |
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| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Amyloid Image Assessment | Four readers blinded to all clinical information classified florbetapir Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read classification is presented as either positive, negative or tied. | 50-60 min after injection |
| Quantitative Amyloid Image Assessment | The effect of diagnostic group on mean total cortical grey matter florbetapir binding relative to cerebellar cortex is presented as standard uptake value ratios (SUVr). | 50-60 minutes after injection |
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Inclusion Criteria:
AD:
FTD:
CN:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Manchester | M20 3LJ | United Kingdom |
34 subjects were enrolled in the trial but 6 subjects did not receive florbetapir and were not included in the Overall Study period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Frontotemporal Disorder | Subjects with frontotemporal disorder (FTD). florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. 18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 18F-FDG | Drug | FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG. |
|
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| Cognitively Normal |
Cognitively normal (CN) subjects. florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. |
| FG002 | Alzheimer's Disease | Subjects with Alzheimer's disease (AD). florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. |
| COMPLETED |
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| NOT COMPLETED |
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Only subjects who received florbetapir (18F) are included in the baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Frontotemporal Disorder | Subjects with frontotemporal disorder (FTD). florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. 18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG. |
| BG001 | Cognitively Normal | Cognitively normal (CN) subjects. florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. |
| BG002 | Alzheimer's Disease | Subjects with Alzheimer's disease (AD). florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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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 | Qualitative Amyloid Image Assessment | Four readers blinded to all clinical information classified florbetapir Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read classification is presented as either positive, negative or tied. | Posted | Number | participants | 50-60 min after injection |
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| Primary | Quantitative Amyloid Image Assessment | The effect of diagnostic group on mean total cortical grey matter florbetapir binding relative to cerebellar cortex is presented as standard uptake value ratios (SUVr). | Posted | Mean | Standard Deviation | SUVr | 50-60 minutes after injection |
|
|
7 days
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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 | Frontotemporal Disorder | Subjects with frontotemporal disorder (FTD). florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. 18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG. | 0 | 8 | 1 | 8 | ||
| EG001 | Cognitively Normal | Cognitively normal (CN) subjects. florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. | 0 | 10 | 0 | 10 | ||
| EG002 | Alzheimer's Disease | Subjects with Alzheimer's disease (AD). florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. | 0 | 10 | 1 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | 215-298-0700 | clinicaloperations@avidrp.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D057180 | Frontotemporal Dementia |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D057174 | Frontotemporal Lobar Degeneration |
| D057177 | TDP-43 Proteinopathies |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C545186 | florbetapir |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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| Male |
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| Title | Measurements |
|---|---|
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| Tie |
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| Participants |
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