Trial Outcomes & Findings for Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired Subjects (NCT NCT04474405)
NCT ID: NCT04474405
Last Updated: 2020-09-25
Results Overview
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.
COMPLETED
EARLY_PHASE1
36 participants
80-100 minutes postdose
2020-09-25
Participant Flow
Enrollment occurred between Aug and Dec 2013. Subjects in the MRI and Amyloid Extension cohort received flortaucipir brain PET scans in Study T807000 (NCT01733355)
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.
Participant milestones
| Measure |
Brain PET Scan (AD Subjects)
Alzheimer's disease (AD) subjects receiving a flortaucipir and florbetapir PET scan
|
Brain PET (MCI Subjects)
Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan
|
Brain PET (YCN Subjects)
Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan
|
Brain PET (OCN Subjects)
Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan
|
Whole Body PET Scan
Subjects receiving a whole body PET scan after flortaucipir administration
|
MRI and Amyloid Extension Cohort
Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000. \[n=3 AD, n=2 MCI, n=1 OCN\]
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
5
|
4
|
13
|
7
|
|
Overall Study
Flortaucipir PET Scan
|
4
|
3
|
4
|
4
|
9
|
0
|
|
Overall Study
Florbetapir PET Scan
|
4
|
3
|
0
|
4
|
0
|
4
|
|
Overall Study
COMPLETED
|
4
|
3
|
4
|
4
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
4
|
0
|
Reasons for withdrawal
| Measure |
Brain PET Scan (AD Subjects)
Alzheimer's disease (AD) subjects receiving a flortaucipir and florbetapir PET scan
|
Brain PET (MCI Subjects)
Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan
|
Brain PET (YCN Subjects)
Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan
|
Brain PET (OCN Subjects)
Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan
|
Whole Body PET Scan
Subjects receiving a whole body PET scan after flortaucipir administration
|
MRI and Amyloid Extension Cohort
Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000. \[n=3 AD, n=2 MCI, n=1 OCN\]
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
3
|
0
|
Baseline Characteristics
Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired Subjects
Baseline characteristics by cohort
| Measure |
Brain PET Scan (AD Subjects)
n=4 Participants
AD subjects receiving a flortaucipir and florbetapir PET scan
|
Brain PET (MCI Subjects)
n=3 Participants
Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan
|
Brain PET (YCN Subjects)
n=4 Participants
Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan
|
Brain PET (OCN Subjects)
n=4 Participants
Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan
|
Whole Body PET Scan
n=9 Participants
Subjects receiving a whole body PET scan after flortaucipir administration
|
MRI and Amyloid Extension Cohort
n=4 Participants
Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000. \[n=3 AD, n=2 MCI, n=1 OCN\]
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.0 years
STANDARD_DEVIATION 7.87 • n=5 Participants
|
78.7 years
STANDARD_DEVIATION 2.89 • n=7 Participants
|
27.5 years
STANDARD_DEVIATION 2.08 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 0.50 • n=4 Participants
|
56.3 years
STANDARD_DEVIATION 4.42 • n=21 Participants
|
73.0 years
STANDARD_DEVIATION 13.09 • n=10 Participants
|
60.1 years
STANDARD_DEVIATION 16.52 • n=115 Participants
|
|
Sex/Gender, Customized
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Sex/Gender, Customized
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
|
Sex/Gender, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 80-100 minutes postdosePopulation: 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.
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.
Outcome measures
| Measure |
Brain PET Scan (AD Subjects)
n=7 Participants
AD subjects receiving a flortaucipir and florbetapir PET scan
|
Brain PET (MCI Subjects)
n=5 Participants
Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan
|
Brain PET (YCN Subjects)
n=4 Participants
Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan
|
Brain PET (OCN Subjects)
n=5 Participants
Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan
|
|---|---|---|---|---|
|
Brain Flortaucipir Uptake
|
1.780 standardized uptake value ratio (SUVr)
Standard Deviation 0.857
|
1.317 standardized uptake value ratio (SUVr)
Standard Deviation 0.161
|
1.128 standardized uptake value ratio (SUVr)
Standard Deviation 0.047
|
1.107 standardized uptake value ratio (SUVr)
Standard Deviation 0.175
|
PRIMARY outcome
Timeframe: injection to 6 hours postdosePopulation: Includes only subjects from the whole body PET scan group (n=9)
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.
Outcome measures
| Measure |
Brain PET Scan (AD Subjects)
n=9 Participants
AD subjects receiving a flortaucipir and florbetapir PET scan
|
Brain PET (MCI Subjects)
Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan
|
Brain PET (YCN Subjects)
Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan
|
Brain PET (OCN Subjects)
Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan
|
|---|---|---|---|---|
|
Flortaucipir Whole Body Effective Dose
|
0.0241 mSv/MBq
Standard Deviation 0.00160
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at baselinePopulation: 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.
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.
Outcome measures
| Measure |
Brain PET Scan (AD Subjects)
n=21 Participants
AD subjects receiving a flortaucipir and florbetapir PET scan
|
Brain PET (MCI Subjects)
Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan
|
Brain PET (YCN Subjects)
Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan
|
Brain PET (OCN Subjects)
Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan
|
|---|---|---|---|---|
|
Flortaucipir PET Correlations With Cognitive Assessments (Mini-mental State Exam)
|
-0.404 correlation coefficient
Interval -0.706 to 0.044
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at baselinePopulation: 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.
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.
Outcome measures
| Measure |
Brain PET Scan (AD Subjects)
n=21 Participants
AD subjects receiving a flortaucipir and florbetapir PET scan
|
Brain PET (MCI Subjects)
Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan
|
Brain PET (YCN Subjects)
Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan
|
Brain PET (OCN Subjects)
Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan
|
|---|---|---|---|---|
|
Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Digit Symbol Substitution Test)
|
-0.273 correlation coefficient
Interval -0.744 to 0.403
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at baselinePopulation: 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.
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.
Outcome measures
| Measure |
Brain PET Scan (AD Subjects)
n=21 Participants
AD subjects receiving a flortaucipir and florbetapir PET scan
|
Brain PET (MCI Subjects)
Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan
|
Brain PET (YCN Subjects)
Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan
|
Brain PET (OCN Subjects)
Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan
|
|---|---|---|---|---|
|
Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Alzheimer's Disease Assessment Scale)
|
0.220 correlation coefficient
Interval -0.447 to 0.719
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: injection to 6 hours postdosePopulation: Includes only subjects from the whole body PET scan group (n=9)
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)
Outcome measures
| Measure |
Brain PET Scan (AD Subjects)
n=9 Participants
AD subjects receiving a flortaucipir and florbetapir PET scan
|
Brain PET (MCI Subjects)
Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan
|
Brain PET (YCN Subjects)
Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan
|
Brain PET (OCN Subjects)
Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan
|
|---|---|---|---|---|
|
Flortaucipir Whole Body Effective Dose With Urine Radioactivity
|
0.0235 mSv/MBq
Standard Deviation 0.0016
|
—
|
—
|
—
|
Adverse Events
Brain PET Scan (AD Subjects)
Brain PET (MCI Subjects)
Brain PET (YCN Subjects)
Brain PET (OCN Subjects)
Whole Body PET Scan
MRI and Amyloid Extension Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brain PET Scan (AD Subjects)
n=4 participants at risk
AD subjects receiving a flortaucipir and florbetapir PET scan
|
Brain PET (MCI Subjects)
n=3 participants at risk
Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan
|
Brain PET (YCN Subjects)
n=4 participants at risk
Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan
|
Brain PET (OCN Subjects)
n=4 participants at risk
Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan
|
Whole Body PET Scan
n=9 participants at risk
Subjects receiving a whole body PET scan after flortaucipir administration
|
MRI and Amyloid Extension Cohort
n=4 participants at risk
Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
headache
|
0.00%
0/4 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/4 • 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.
|
0.00%
0/4 • 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.
|
22.2%
2/9 • Number of events 2 • 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.
|
0.00%
0/4 • 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.
|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/4 • 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.
|
0.00%
0/3 • 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.
|
25.0%
1/4 • Number of events 1 • 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.
|
0.00%
0/4 • 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.
|
0.00%
0/9 • 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.
|
0.00%
0/4 • 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.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal discomfort
|
0.00%
0/4 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/4 • 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.
|
0.00%
0/4 • 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.
|
11.1%
1/9 • Number of events 1 • 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.
|
0.00%
0/4 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60