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This study will test two different doses of florbetapir F 18 to determine which dose is best to image amyloid plaques in the brains of Alzheimer's Disease (AD) patients using a positron emission tomography (PET) scanner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 111 MBq (3 mCi) AD Group | Experimental | Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel |
|
| 111 MBq (3 mCi) Control Group | Experimental | Healthy controls who received 111MBq (3 mCi) of florbetapir F 18 |
|
| 370 MBq (10 mCi) AD Group | Experimental | Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18 |
|
| 370 MBq (10 mCi) Control Group | Experimental | Healthy controls who received 370MBq (10 mCi) of florbetapir F 18. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| florbetapir F 18 | Drug | single dose IV injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Florbetapir-PET Scan Quality | Visual evaluation of image quality by nuclear medicine specialist blinded to dose and clinical information; reported on a 5-point scale (5=excellent and 1=poor). | 0-90 min after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Cortical to Cerebellum SUVR | Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum. | 0-90 min after injection |
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Inclusion Criteria (AD group):
Inclusion Criteria (healthy volunteer group):
Exclusion Criteria (both groups):
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | West Palm Beach | Florida | 33407 | United States | ||
| Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | 111 MBq (3 mCi) AD Group | Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel |
| FG001 | 111 MBq (3 mCi) Control Group | Healthy controls who received 111MBq (3 mCi) of florbetapir F 18 |
| FG002 | 370 MBq (10 mCi) AD Group | Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18 |
| FG003 | 370 MBq (10 mCi) Control Group | Healthy controls who received 370MBq (10 mCi) of florbetapir F 18 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 111 MBq (3 mCi) AD Group | Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel |
| BG001 | 111 MBq (3 mCi) Control Group | Healthy controls who received 111MBq (3 mCi) of florbetapir F 18 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Florbetapir-PET Scan Quality | Visual evaluation of image quality by nuclear medicine specialist blinded to dose and clinical information; reported on a 5-point scale (5=excellent and 1=poor). | One subject in the 370 MBq (10 mCi) AD Group did not complete all imaging time periods | Posted | Number | florbetapir scans | 0-90 min after injection |
|
AEs reported within 7 days of injection; SAEs reported within 30 days of injection.
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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 | 111 MBq (3 mCi) AD Group | Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | 215-290-0700 | clinicaloperations@avidrp.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 |
|---|---|
| C545186 | florbetapir |
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|
| North East |
| Maryland |
| 21901 |
| United States |
| Research Site | Clementon | New Jersey | 08021 | United States |
| BG002 | 370 MBq (10 mCi) AD Group | Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18 |
| BG003 | 370 MBq (10 mCi) Control Group | Healthy controls who received 370MBq (10 mCi) of florbetapir F 18 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 370 MBq (10 mCi) AD Group | Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18 |
| OG003 | 370 MBq (10 mCi) Control Group | Healthy controls who received 370MBq (10 mCi) of florbetapir F 18 |
|
|
| Secondary | Mean Cortical to Cerebellum SUVR | Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum. | Posted | Mean | Standard Deviation | SUVR | 0-90 min after injection |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 111 MBq (3 mCi) Control Group | Healthy controls who received 111MBq (3 mCi) of florbetapir F 18 | 0 | 4 | 0 | 4 |
| EG002 | 370 MBq (10 mCi) AD Group | Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18 | 0 | 4 | 0 | 4 |
| EG003 | 370 MBq (10 mCi) Control Group | Healthy controls who received 370MBq (10 mCi) of florbetapir F 18 | 0 | 7 | 2 | 7 |
| VOMITING | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| INJECTION SITE IRRITATION | General disorders | MedDRA (11.0) | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |