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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
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Subjects enrolled in the Professional Fighters Brain Health Study (PFBHS) will receive flortaucipir to explore its use as a biomarker for brain injury related to repetitive head trauma and to examine the relationship between clinical presentation and tau deposition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Professional Fighters | Experimental | Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan |
|
| Retired Professional Fighters | Experimental | Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flortaucipir F18 | Drug | IV injection, 370 megabecquerel (MBq) (10 mCi) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flortaucipir Imaging (Quantitative) Between Cognitive Groups | Standard Uptake Value Ratio (SUVr) by subject enrollment group (cognitive impaired/normal) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. | baseline scan |
| Flortaucipir Imaging (Quantitative) Between Fighter Groups | Standard Uptake Value Ratio (SUVr) by subject enrollment group (active fighter/retired fighter) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. | baseline scan |
| Flortaucipir Imaging (Qualitative) Between Cognitive Groups | Qualitative read results (no, mild, moderate, or intense uptake) compared between cognitively impaired (CI) and cognitively normal (CN) groups. | baseline scan |
| Flortaucipir Imaging (Qualitative) Between Fighter Groups | Qualitative read results (no, mild, moderate, or intense uptake) compared between active and retired fighter groups | baseline scan |
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Inclusion Criteria:
All Subjects
Subjects with cognitive impairment
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Lou Ruvo Center for Brain Health | Las Vegas | Nevada | 89106 | United States |
Five subjects enrolled in the study but did not receive a flortaucipir PET scan (2 active, 3 retired). Two additional subjects in the active fighters group did not have the minimum 10 fights required for inclusion into the study, and therefore were considered not to have completed the study. However, their PET scan results were analyzed.
Enrollment occurred between Feb 2015 and Feb 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Professional Fighters | Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan |
| FG001 | Retired Professional Fighters | Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only includes subjects who received a flortaucipir PET scan in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Professional Fighters | Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan |
| BG001 | Retired Professional Fighters | Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan |
| 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 | Flortaucipir Imaging (Quantitative) Between Cognitive Groups | Standard Uptake Value Ratio (SUVr) by subject enrollment group (cognitive impaired/normal) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. | Cognitively impaired fighters either had subjective cognitive complaints or objective decline or impairment as determined by the investigator. | Posted | Least Squares Mean | 95% Confidence Interval | standardized uptake value ratio (SUVr) | baseline scan |
|
End of study for AE reporting was 48 hours after the last study drug administration.
Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection. AEs occurring after flortaucipir administration, but outside that window were not recorded in the database, unless considered attributable to flortaucipir 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 | Active Professional Fighters | Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhoea | Gastrointestinal 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 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2015 | Jul 15, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2017 | Jul 15, 2020 | SAP_001.pdf |
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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 |
|---|---|
| C000591008 | 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole |
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| Brain PET scan | Procedure | positron emission tomography (PET) scan of the brain 75-105 minutes post injection |
|
| <10 professional fights |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Amyloid status | Amyloid status determined by florbetapir PET scan | Per protocol, baseline amyloid status was only obtained for fighters > 50 years of age or with a clinical presentation that suggested a possible Alzheimer's disease diagnosis (n=15) | Count of Participants | Participants |
|
| Cognitively Normal Fighters |
Fighters (active and retired) without cognitive impairment at baseline |
|
|
| Primary | Flortaucipir Imaging (Quantitative) Between Fighter Groups | Standard Uptake Value Ratio (SUVr) by subject enrollment group (active fighter/retired fighter) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. | Posted | Least Squares Mean | 95% Confidence Interval | standardized uptake value ratio (SUVr) | baseline scan |
|
|
|
| Primary | Flortaucipir Imaging (Qualitative) Between Cognitive Groups | Qualitative read results (no, mild, moderate, or intense uptake) compared between cognitively impaired (CI) and cognitively normal (CN) groups. | Cognitively impaired fighters either had subjective cognitive complaints or objective decline or impairment as determined by the investigator. | Posted | Count of Participants | Participants | baseline scan |
|
|
|
| Primary | Flortaucipir Imaging (Qualitative) Between Fighter Groups | Qualitative read results (no, mild, moderate, or intense uptake) compared between active and retired fighter groups | Posted | Count of Participants | Participants | baseline scan |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Retired Professional Fighters | Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan | 0 | 20 | 0 | 20 | 2 | 20 |
| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Other |
|
| Temporal |
|
| Parietal |
|
| Occipital |
|
| Moderate Uptake |
|
| Intense Uptake |
|
| Moderate Uptake |
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| Intense Uptake |
|