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This study will test if two AV-45 PET scans up to 4 weeks apart in AD subjects and healthy volunteers provide the same results. The study will also test two different AV-45 injection methods in a small subgroup of enrolled AD subjects (slow vs. fast bolus group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD Subjects | Experimental | Two bolus IV injections followed by brain PET scan up to 4 weeks apart |
|
| AD Subjects: Slow vs. Fast Bolus | Experimental | Two bolus IV injections followed by a brain PET scan up to 4 weeks apart. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration). |
|
| Healthy controls | Experimental | Healthy male or female subjects; 35-55 years old. Two bolus IV injections followed by brain PET scan up to 4 weeks apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| florbetapir F 18 | Drug | IV injection, 370MBq (10mCi) |
|
| 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. | 50-70 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 | New Haven | Connecticut | 06510 | United States | ||
| Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | AD Subjects | Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24 |
| FG001 | AD Subjects: Slow vs. Fast Bolus Group | Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration). |
| FG002 | Control Subjects | Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AD Subjects | Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24 |
| BG001 | AD Subjects: Slow vs. Fast Bolus Group | Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration). |
| 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 | 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. | Due to poor subject positioning that resulted in an incomplete brain image on the retest image day, accurate quantitative analysis for one healthy control was not possible, and the subject was excluded from the SUVR-based analyses. | Posted | Mean | Standard Deviation | SUVR | 50-70 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 | AD Subjects | Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SUPRAVENTRICULAR EXTRASYSTOLES | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | 215-298-0700 | 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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| Hallandale |
| Florida |
| 33009 |
| United States |
| Research Site | West Palm Beach | Florida | 33407 | United States |
| Research Site | North East | Maryland | 21901 | United States |
| BG002 | Control Subjects | Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Control Subjects |
Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher |
|
|
|
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | AD Subjects: Slow vs. Fast Bolus Group | Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration). | 0 | 4 | 0 | 4 |
| EG002 | Control Subjects | Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher | 0 | 10 | 1 | 10 |
| VENTRICULAR EXTRASYSTOLES | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |