Alzheimer's Disease
Conditions
Brief summary
This study will obtain data from urine in subjects administered flortaucipir in an Avid-sponsored study to augment the calculation of radiation dosimetry estimates.
Interventions
DRUGFlortaucipir F18
No flortaucipir administered in this study. Subjects received flortaucipir in an Avid-sponsored study.
Sponsors
Avid Radiopharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Subjects who passed screening in an Avid-sponsored study in which flortaucipir will be administered
Exclusion criteria
* Subjects who have withdrawn informed consent * Investigator or sponsor believes it is in the best interest of the subject to be removed from the trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine Analysis - Total Integrated Radioactivity Excreted in Urine | 0-360 minutes post injection | Total integrated radioactivity excreted in urine over time will be determined to augment previous radiation dosimetry calculations. |
Countries
United States
Participant flow
Recruitment details
Enrollment occurred from Jan-Jun 2015 from Avid sponsored study 18F-AV-1451-A05 (NCT02016560)
Participants by arm
| Arm | Count |
|---|---|
| Urine Analysis Subjects administered flortaucipir in an Avid-sponsored study consenting to urine radioactivity analysis | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Urine Analysis |
|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 11.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Urine Analysis - Total Integrated Radioactivity Excreted in Urine
Total integrated radioactivity excreted in urine over time will be determined to augment previous radiation dosimetry calculations.
Time frame: 0-360 minutes post injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Urine Analysis | Urine Analysis - Total Integrated Radioactivity Excreted in Urine | 0.1413 megabecquerel-hours per megabecquerel | Standard Deviation 0.07216 |