Alzheimer's Disease, Depression, Traumatic Brain Injury
Conditions
Brief summary
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.
Interventions
DRUGFlortaucipir F18
IV injection, 370 MBq (10 mCi), up to two doses
PROCEDUREBrain PET scan
positron emission tomography (PET) scan of the brain
Sponsors
Avid Radiopharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects should meet inclusion and
Exclusion criteria
for the companion protocol in addition to the criteria below. Inclusion Criteria: * Subjects who have a historical volumetric magnetic resonance imaging (MRI) as part of the companion study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events Related to Flortaucipir Administration | within 48 hours of drug 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). |
| Flortaucipir PET Scan SUVr | baseline and follow-up scans | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cognitively Impaired Cognitively impaired subjects receiving a flortaucipir PET scan | 69 |
| Cognitively Normal Cognitively normal subjects receiving a flortaucipir PET scan | 110 |
| Total | 179 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 5 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | Cognitively Impaired | Cognitively Normal | Total |
|---|---|---|---|
| Age, Continuous | 72.7 years STANDARD_DEVIATION 7.6 | 70.4 years STANDARD_DEVIATION 8.18 | 71.3 years STANDARD_DEVIATION 8.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 10 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants | 100 Participants | 169 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| MMSE | 21 score on a scale STANDARD_DEVIATION 4.35 | 29.3 score on a scale STANDARD_DEVIATION 1.06 | 26.1 score on a scale STANDARD_DEVIATION 4.92 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 62 Participants | 105 Participants | 167 Participants |
| Region of Enrollment United States | 69 participants | 110 participants | 179 participants |
| Sex: Female, Male Female | 34 Participants | 68 Participants | 102 Participants |
| Sex: Female, Male Male | 35 Participants | 42 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 110 |
| other Total, other adverse events | 6 / 69 | 16 / 110 |
| serious Total, serious adverse events | 0 / 69 | 0 / 110 |
Outcome results
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.
Time frame: baseline and follow-up scans
Population: Includes only subjects for whom a quantitative image analysis was possible
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitively Impaired | Flortaucipir PET Scan SUVr | Baseline SUVr | 1.3983 standardized uptake value ratio (SUVr) | Standard Deviation 0.3641 |
| Cognitively Impaired | Flortaucipir PET Scan SUVr | Follow-up Scan SUVr | 1.4404 standardized uptake value ratio (SUVr) | Standard Deviation 0.37426 |
| Cognitively Normal | Flortaucipir PET Scan SUVr | Baseline SUVr | 1.004 standardized uptake value ratio (SUVr) | Standard Deviation 0.04871 |
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).
Time frame: within 48 hours of drug administration
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cognitively Impaired | Number of Participants With Adverse Events Related to Flortaucipir Administration | Headache | 0 Participants |
| Cognitively Impaired | Number of Participants With Adverse Events Related to Flortaucipir Administration | Dysgeusia | 0 Participants |
| Cognitively Normal | Number of Participants With Adverse Events Related to Flortaucipir Administration | Headache | 3 Participants |
| Cognitively Normal | Number of Participants With Adverse Events Related to Flortaucipir Administration | Dysgeusia | 3 Participants |