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This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSP Subjects | Experimental | Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months. |
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| CBD subjects | Experimental | Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months. |
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| Healthy volunteers | Experimental | Healthy volunteers receiving a flortaucipir PET scan at baseline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flortaucipir F18 | Drug | IV injection, 370 megabecquerel (MBq) (10 mCi) |
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| Measure | Description | Time Frame |
|---|---|---|
| Flortaucipir Imaging in PSP, CBD and Healthy Volunteers | A PSP/CBD (PSP = progressive supranuclear palsy; CBD = corticobasal degeneration) targeted composite Standardized Uptake Value ratio (SUVr) was calculated as the voxel-weighted average from the regional SUVr values of the left, right, and total globus pallidus and the dentate nuclei of the cerebellum for both the baseline and 9 month PET scans. Additionally, a global cortical Alzheimer's Disease (AD)-targeted cortical SUVr was calculated. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. | baseline and 9 month scans |
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Inclusion Criteria:
Cognitively Healthy Volunteers
CBD and PSP subjects
PSP subjects only
CBD subjects only
Exclusion Criteria:
All subjects
PSP and CBD subjects
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Avid Radiopharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| UCSD Movement Disorder Clinic |
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Subjects recruited between Aug 2014 and Jul 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | PSP Subjects | Amyloid negative subjects with Progressive Supranuclear Palsy (PSP) receiving a flortaucipir PET scan |
| FG001 | CBD Subjects | Amyloid negative subjects with Corticobasal Degeneration (CBD) receiving a flortaucipir PET scan |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Brain PET scan | Procedure | positron emission tomography (PET) scan of the brain 75-105 minutes post-injection |
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| La Jolla |
| California |
| 92037 |
| United States |
| UCSF Neurosciences Clinical Research Unit | San Francisco | California | 94158 | United States |
| Molecular Neuroimaging | New Haven | Connecticut | 06510 | United States |
| Perelman School of Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| FG002 | Healthy Volunteers | Healthy volunteers receiving a flortaucipir PET scan |
| COMPLETED | Completed = 9 month flortaucipir PET scan acquired |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PSP Subjects | Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months. Flortaucipir F18 PET scan: IV injection, 370 MBq (10 mCi) |
| BG001 | CBD Subjects | Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months. Flortaucipir F18 PET scan: IV injection, 370 MBq (10 mCi) |
| BG002 | Healthy Volunteers | Healthy volunteers receiving a flortaucipir PET scan at baseline. Flortaucipir F18 PET scan: IV injection, 370 MBq (10 mCi) |
| 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Mini Mental Status Exam (MMSE) | Mini-mental status exam (MMSE) is a 30-point questionnaire that is used to measure cognitive impairment. Scores range from 0 to 30 with lower scores representing greater levels of cognitive impairment. | Mean | Standard Deviation | units on a scale |
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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 | Flortaucipir Imaging in PSP, CBD and Healthy Volunteers | A PSP/CBD (PSP = progressive supranuclear palsy; CBD = corticobasal degeneration) targeted composite Standardized Uptake Value ratio (SUVr) was calculated as the voxel-weighted average from the regional SUVr values of the left, right, and total globus pallidus and the dentate nuclei of the cerebellum for both the baseline and 9 month PET scans. Additionally, a global cortical Alzheimer's Disease (AD)-targeted cortical SUVr was calculated. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. | Healthy volunteers did not receive 9 month follow-up scans. 9 month data presented only for those subjects who completed both a baseline and 9 month scan. | Posted | Mean | Standard Deviation | standardized uptake value ratio (SUVr) | baseline and 9 month scans |
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End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.
Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to flortaucipir.
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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 | PSP Subjects | Amyloid negative subjects with Progressive Supranuclear Palsy (PSP) receiving a flortaucipir PET scan | 0 | 20 | 0 | 20 | 2 | 20 |
| EG001 | CBD Subjects | Amyloid negative subjects with Corticobasal Degeneration (CBD) receiving a flortaucipir PET scan | 1 | 6 | 0 | 6 | 1 | 6 |
| EG002 | Healthy Volunteers | Healthy volunteers receiving a flortaucipir PET scan | 0 | 3 | 0 | 3 | 0 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bronchial secretion retention | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
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| muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| asthenia | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Avid Radiopharmaceuticals, Inc. | 215-298-0700 | clinicaloperations@avidrp.com |
| ID | Term |
|---|---|
| D013494 | Supranuclear Palsy, Progressive |
| D000088282 | Corticobasal Degeneration |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D009886 | Ophthalmoplegia |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591008 | 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Right Dentate 9 months |
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| Left Dentate Baseline |
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| Left Dentate 9 months |
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| Right Globus Pallidus Baseline |
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| Right Globus Pallidus 9 Months |
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| Left Globus Pallidus Baseline |
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| Left Globus Pallidus 9 Months |
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| Global PSP/CBD Summary Baseline |
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| Global PSP/CBD Summary 9 Months |
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| AD Cortical Baseline |
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| AD Cortical 9 Months |
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