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This study is designed to expand the database of flortaucipir F 18 safety and tau binding as measured by PET imaging and to provide standardized conditions for flortaucipir PET use, data collection and analysis to facilitate companion studies including, but not limited to, longitudinal studies of aging, depression, and traumatic brain injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flortaucipir PET Scans | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flortaucipir F18 | Drug | IV injection, 370 MBq (10 mCi), up to two doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events Related to Flortaucipir Administration | Frequency of treatment-emergent adverse events considered related to flortaucipir administration by the study investigator. Related events with a frequency > 1.5% are reported. (note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in "Adverse Events" section below). | within 48 hours of drug administration |
| Flortaucipir PET Scan SUVr | Standard Uptake Value Ratio (SUVr) using a weighted cortical average. 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 and follow-up scans |
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Subjects should meet inclusion and exclusion criteria for the companion protocol in addition to the criteria below.
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Alzheimer's Institute | Phoenix | Arizona | 85006 | United States | ||
| Yale University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitively Impaired | Cognitively impaired subjects receiving a flortaucipir PET scan |
| FG001 | Cognitively Normal | Cognitively normal subjects receiving a flortaucipir PET scan |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitively Impaired | Cognitively impaired subjects receiving a flortaucipir PET scan |
| BG001 | Cognitively Normal | Cognitively normal subjects 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 | Number of Participants With Adverse Events Related to Flortaucipir Administration | Frequency of treatment-emergent adverse events considered related to flortaucipir administration by the study investigator. Related events with a frequency > 1.5% are reported. (note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in "Adverse Events" section below). | Posted | Count of Participants | Participants | within 48 hours of drug administration |
|
AEs were collected at scan visit and for 48 hours after flortaucipir administration.
AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
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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 | Cognitively Impaired | Cognitively impaired subjects receiving a flortaucipir PET scan |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | MedDRA (17.1) | 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 | Sep 5, 2014 | Jul 14, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2019 | Jul 14, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D000070642 | Brain Injuries, Traumatic |
| D003863 | Depression |
| 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 |
|
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Cleveland Clinic Lou Ruvo Center for Brain Health | Las Vegas | Nevada | 89106 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Center for Vital Longevity at the University of Texas at Dallas | Dallas | Texas | 75235 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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 | score on a scale |
|
|
|
| Primary | Flortaucipir PET Scan SUVr | Standard Uptake Value Ratio (SUVr) using a weighted cortical average. 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. | Includes only subjects for whom a quantitative image analysis was possible | Posted | Mean | Standard Deviation | standardized uptake value ratio (SUVr) | baseline and follow-up scans |
|
|
|
| 0 |
| 69 |
| 0 |
| 69 |
| 6 |
| 69 |
| EG001 | Cognitively Normal | Cognitively normal subjects receiving a flortaucipir PET scan | 0 | 110 | 0 | 110 | 16 | 110 |
| dysgeusia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| paraesthesia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| injection site pain | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| asthenia | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| feeling abnormal | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| gait abnormal | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| injection site coldness | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| blood pressure increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| palpitations | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
|
| nasopharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| procedural headache | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
| loss of bladder sensation | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
|
| hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| Follow-up Scan SUVr |
|
|