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This early phase 1 study explored the brain uptake, retention, and safety of flortaucipir and obtained preliminary information regarding dosimetry of flortaucipir.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain flortaucipir PET scan | Experimental | Subjects receiving a brain PET scan after flortaucipir administration |
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| Whole body flortaucipir PET scan | Experimental | Subjects receiving a whole body PET scan after flortaucipir administration |
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| MRI and Amyloid Extension Cohort | Other | Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000 (NCT01733355) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flortaucipir F18 | Drug | IV injection, 370 MBq (10 mCi), single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Brain Flortaucipir Uptake | Brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVr), normalized to the entire cerebellum. A global cortical average volume of interest (VOI) is the average SUVr of the occipital cortex, parietal cortex, and temporal cortex. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. | 80-100 minutes postdose |
| Flortaucipir Whole Body Effective Dose | Radiation dose estimates measured in millisieverts per megabecquerel (mSv/MBq) for the whole body obtained from Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) radiation dosimetry code. Results calculated using 73.7-kg man model. | injection to 6 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Flortaucipir PET Correlations With Cognitive Assessments (Mini-mental State Exam) | Spearman's correlations between flortaucipir SUVr and cognitive function as measured on the Mini-Mental State Examination (MMSE). MMSE is a 30-point questionnaire that is used to measure cognitive impairment. 0 is the lowest score and 30 is the highest score, indicating normal cognitive function. Lower MMSE scores indicate worsening cognitive function. For this analysis, negative correlation values indicate that higher flortaucipir uptake is associated with decreasing cognitive function and positive correlation values indicate that lower flortaucipir uptake is associated with better cognitive function. 95% confidence interval uses a Fisher's z transformation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Avid Radiopharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT Global, LLC | Cypress | California | 90630 | United States | ||
| Hoag Memorial Hospital Presbyterian |
Subjects enrolled in the MRI/amyloid extension cohort were to be combined with the Brain PET subgroups for analysis per protocol. MRI allows previously-obtained flortaucipir scan and cognitive data to be combined with the PET scan results from the Brain PET subgroups for analysis.
Enrollment occurred between Aug and Dec 2013. Subjects in the MRI and Amyloid Extension cohort received flortaucipir brain PET scans in Study T807000 (NCT01733355)
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| ID | Title | Description |
|---|---|---|
| FG000 | Brain PET Scan (AD Subjects) | Alzheimer's disease (AD) subjects receiving a flortaucipir and florbetapir PET scan |
| FG001 | Brain PET (MCI Subjects) | Mild cognitive impairment (MCI) subjects receiving a florbetapir and 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 starting immediately after administration (60 minute dynamic imaging plus 4 frames x 5 minutes at approximately 80 minutes post-dose). |
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| Whole body PET scan | Procedure | positron emission tomography (PET) scan of the body from the vertex of the head to the thighs starting immediately following injection and repeated over 6 hours |
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| Florbetapir F 18 | Drug | IV injection, 370 MBq (10 mCi), single dose |
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| Brain MRI | Procedure | Volume-based T1-weighted Magnetic Resonance Imaging (MRI) of the brain |
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| at baseline |
| Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Digit Symbol Substitution Test) | Spearman's correlations between flortaucipir SUVr and cognitive function as measured on Digit Symbol Substitution Test (DSST). The DSST is sensitive to the presence of cognitive dysfunction as well as to change in cognitive function. Scores range from 0 to 133. Lower DSST scores indicate worsening cognitive function. For this analysis, negative correlation values indicate that higher flortaucipir uptake is associated with decreasing cognitive function and positive correlation values indicate that lower flortaucipir uptake is associated with better cognitive function. 95% confidence interval uses a Fisher's z transformation. | at baseline |
| Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Alzheimer's Disease Assessment Scale) | Spearman's correlations between flortaucipir SUVr and cognitive function as measured on a Modified Alzheimer's Disease Assessment Scale (ADAS)-Cognitive subscale (including orientation, verbal memory, language, and praxis, minus the spoken language assessment). Scores on the modified scale can range from 0 to 65. Higher scores indicate worsening cognitive function. For this analysis, positive correlation values indicate that higher flortaucipir uptake is associated with decreasing cognitive function and negative correlation values indicate that lower flortaucipir uptake is associated with better cognitive function. 95% confidence interval uses a Fisher's z transformation. | at baseline |
| Newport Beach |
| California |
| 92658 |
| United States |
| FG002 | Brain PET (YCN Subjects) | Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan |
| FG003 | Brain PET (OCN Subjects) | Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan |
| FG004 | Whole Body PET Scan | Subjects receiving a whole body PET scan after flortaucipir administration |
| FG005 | MRI and Amyloid Extension Cohort | Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000. [n=3 AD, n=2 MCI, n=1 OCN] |
| Flortaucipir PET Scan |
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| Florbetapir PET Scan |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline demographics analysis includes subjects receiving a florbetapir or a flortaucipir PET scan in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brain PET Scan (AD Subjects) | AD subjects receiving a flortaucipir and florbetapir PET scan |
| BG001 | Brain PET (MCI Subjects) | Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan |
| BG002 | Brain PET (YCN Subjects) | Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan |
| BG003 | Brain PET (OCN Subjects) | Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan |
| BG004 | Whole Body PET Scan | Subjects receiving a whole body PET scan after flortaucipir administration |
| BG005 | MRI and Amyloid Extension Cohort | Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000. [n=3 AD, n=2 MCI, n=1 OCN] |
| BG006 | 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/Gender, Customized | 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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| 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 | Brain Flortaucipir Uptake | Brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVr), normalized to the entire cerebellum. A global cortical average volume of interest (VOI) is the average SUVr of the occipital cortex, parietal cortex, and temporal cortex. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. | Includes quantitative flortaucipir PET scan results from subjects with a flortaucipir scan in the present study (n=15), plus subjects consented in the MRI/Amyloid extension cohort who provided valid flortaucipir PET scans (n=3 AD, n=2 MCI, n=1 OCN) and received MRI in the present study permitting quantitative analysis per protocol. | Posted | Mean | Standard Deviation | standardized uptake value ratio (SUVr) | 80-100 minutes postdose |
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| Primary | Flortaucipir Whole Body Effective Dose | Radiation dose estimates measured in millisieverts per megabecquerel (mSv/MBq) for the whole body obtained from Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) radiation dosimetry code. Results calculated using 73.7-kg man model. | Includes only subjects from the whole body PET scan group (n=9) | Posted | Mean | Standard Deviation | mSv/MBq | injection to 6 hours postdose |
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| Secondary | Flortaucipir PET Correlations With Cognitive Assessments (Mini-mental State Exam) | Spearman's correlations between flortaucipir SUVr and cognitive function as measured on the Mini-Mental State Examination (MMSE). MMSE is a 30-point questionnaire that is used to measure cognitive impairment. 0 is the lowest score and 30 is the highest score, indicating normal cognitive function. Lower MMSE scores indicate worsening cognitive function. For this analysis, negative correlation values indicate that higher flortaucipir uptake is associated with decreasing cognitive function and positive correlation values indicate that lower flortaucipir uptake is associated with better cognitive function. 95% confidence interval uses a Fisher's z transformation. | Includes quantitative flortaucipir brain PET scan results from subjects with a flortaucipir scan in the present study (n=15), plus subjects consented in the MRI/Amyloid extension cohort who provided valid flortaucipir PET scans from a previous study (n=6) and received MRI in the present study permitting quantitation per protocol. | Posted | Number | 95% Confidence Interval | correlation coefficient | at baseline |
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| Secondary | Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Digit Symbol Substitution Test) | Spearman's correlations between flortaucipir SUVr and cognitive function as measured on Digit Symbol Substitution Test (DSST). The DSST is sensitive to the presence of cognitive dysfunction as well as to change in cognitive function. Scores range from 0 to 133. Lower DSST scores indicate worsening cognitive function. For this analysis, negative correlation values indicate that higher flortaucipir uptake is associated with decreasing cognitive function and positive correlation values indicate that lower flortaucipir uptake is associated with better cognitive function. 95% confidence interval uses a Fisher's z transformation. | Includes quantitative flortaucipir PET scan results from subjects with a flortaucipir scan in the present study (n=15), plus subjects consented in the MRI/Amyloid extension cohort who provided valid flortaucipir PET scans from a previous study n=6) and received MRI in the present study permitting quantitation per protocol. | Posted | Number | 95% Confidence Interval | correlation coefficient | at baseline |
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| Secondary | Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Alzheimer's Disease Assessment Scale) | Spearman's correlations between flortaucipir SUVr and cognitive function as measured on a Modified Alzheimer's Disease Assessment Scale (ADAS)-Cognitive subscale (including orientation, verbal memory, language, and praxis, minus the spoken language assessment). Scores on the modified scale can range from 0 to 65. Higher scores indicate worsening cognitive function. For this analysis, positive correlation values indicate that higher flortaucipir uptake is associated with decreasing cognitive function and negative correlation values indicate that lower flortaucipir uptake is associated with better cognitive function. 95% confidence interval uses a Fisher's z transformation. | Includes quantitative flortaucipir PET scan results from subjects with a flortaucipir scan in the present study (n=15), plus subjects consented in the MRI/Amyloid extension cohort who provided valid flortaucipir PET scans from a previous study (n=6) and received MRI in the present study permitting quantitation per protocol. | Posted | Number | 95% Confidence Interval | correlation coefficient | at baseline |
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| Post-Hoc | Flortaucipir Whole Body Effective Dose With Urine Radioactivity | Radiation dose estimates measured in millisieverts per megabecquerel (mSv/MBq) for the whole body obtained from Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) radiation dosimetry code. Results calculated using 73.7-kg man model and accounting for total integrated radioactivity excreted in the urine collected in Study A15 (NCT02336360) | Includes only subjects from the whole body PET scan group (n=9) | Posted | Mean | Standard Deviation | mSv/MBq | injection to 6 hours postdose |
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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 of florbetapir or flortaucipir. AEs occurring after study drug administration, but outside that window were not recorded in the database, unless considered attributable to study drug injection. MRI/Amyloid extension cohort n=4 represents only those subjects receiving florbetapir PET scans.
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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 | Brain PET Scan (AD Subjects) | AD subjects receiving a flortaucipir and florbetapir PET scan | 0 | 4 | 0 | 4 | 0 | 4 |
| EG001 | Brain PET (MCI Subjects) | Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Brain PET (YCN Subjects) | Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan | 0 | 4 | 0 | 4 | 1 | 4 |
| EG003 | Brain PET (OCN Subjects) | Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan | 0 | 4 | 0 | 4 | 0 | 4 |
| EG004 | Whole Body PET Scan | Subjects receiving a whole body PET scan after flortaucipir administration | 0 | 9 | 0 | 9 | 3 | 9 |
| EG005 | MRI and Amyloid Extension Cohort | Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000 | 0 | 4 | 0 | 4 | 0 | 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
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| diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
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| musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Avid Radiopharmaceuticals, Inc. | 215-298-0700 | clinicaloperations@avidrp.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000591008 | 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole |
| C545186 | florbetapir |
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| Male |
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| Unknown |
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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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