Cognitive Decline
Conditions
Brief summary
This study is designed to assess the imaging characteristics of Flortaucipir (18F-AV-1451) in subjects who participated in the Biomarkers of Cognitive Decline Among Normal Individuals (BIOCARD) study at Johns Hopkins University.
Interventions
DRUGFlortaucipir F18
370 megabecquerel (MBq)(10 millicurie \[mCi\]) single dose
PROCEDUREBrain PET scan
positron emission tomography (PET) scan of the brain
Sponsors
Avid Radiopharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Males or females that have provided consent and are currently enrolled in BIOCARD study * Ability to tolerate PET scan procedures * Ability to provide informed consent for study procedures
Exclusion criteria
* Has condition(s) that could augment risk to participant or compromise ability to tolerate experimental procedures or interfere with analysis of the study data as determined by the investigator * Has a history of risk factors for Torsades de Pointes or taking medications known to cause QT prolongation. * Has electrocardiogram acquired prior to initial flortaucipir scan that clinically contradicts subject's participation in the study as determined by the investigator. Bazett's corrected QT (QTcB) interval must be assessed and not exceed accepted values (458 msec in males, 474 msec in females). * Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraceptive methods. * Has hypersensitivity to flortaucipir * Has a currently clinically significant infectious disease, endocrine/metabolic disease, pulmonary/renal/hepatic impairment, or cancer that could impact study participation or scan results in the opinion of the investigator. * Has a non-study related radiopharmaceutical imaging/treatment procedure within seven days prior to flortaucipir imaging visit. * Is unsuitable for a study of this type in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Evaluation of Scan Results | Baseline scan | Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions. |
| Quantitative Evaluation of Scan Results | 75 minutes post dose administration | Standard Uptake Value Ratio (SUVr) by amyloid status 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
Recruitment details
Enrollment took place between Mar 2017 and Aug 2018 from the Biomarkers of Cognitive Decline Among Normal Individuals (BIOCARD) study
Participants by arm
| Arm | Count |
|---|---|
| Amyloid Positive Clinically normal amyloid positive subjects from BIOCARD study | 18 |
| Amyloid Negative Clinically normal amyloid negative subjects from BIOCARD study | 5 |
| Total | 23 |
Baseline characteristics
| Characteristic | Amyloid Positive | Amyloid Negative | Total |
|---|---|---|---|
| Age, Continuous | 72.1 years STANDARD_DEVIATION 5.69 | 66.8 years STANDARD_DEVIATION 7.53 | 70.9 years STANDARD_DEVIATION 6.35 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 4 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| MMSE | 29.3 units on a scale STANDARD_DEVIATION 1.02 | 29.2 units on a scale STANDARD_DEVIATION 1.3 | 29.3 units on a scale STANDARD_DEVIATION 1.05 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 5 Participants | 23 Participants |
| Region of Enrollment United States | 18 participants | 5 participants | 23 participants |
| Sex: Female, Male Female | 10 Participants | 4 Participants | 14 Participants |
| Sex: Female, Male Male | 8 Participants | 1 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 5 |
| other Total, other adverse events | 2 / 18 | 0 / 5 |
| serious Total, serious adverse events | 0 / 18 | 0 / 5 |
Outcome results
Primary
Qualitative Evaluation of Scan Results
Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.
Time frame: Baseline scan
Population: Subjects with visually evaluable PET scans (n=22). One scan was considered unevaluable by the expert reader.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Amyloid Positive | Qualitative Evaluation of Scan Results | Advanced AD Scan Pattern (τAD++) | 11 Participants |
| Amyloid Positive | Qualitative Evaluation of Scan Results | Moderate AD Scan Pattern (τAD+) | 0 Participants |
| Amyloid Positive | Qualitative Evaluation of Scan Results | Not AD Scan Pattern (τAD-) | 6 Participants |
| Amyloid Negative | Qualitative Evaluation of Scan Results | Advanced AD Scan Pattern (τAD++) | 0 Participants |
| Amyloid Negative | Qualitative Evaluation of Scan Results | Moderate AD Scan Pattern (τAD+) | 0 Participants |
| Amyloid Negative | Qualitative Evaluation of Scan Results | Not AD Scan Pattern (τAD-) | 5 Participants |
Primary
Quantitative Evaluation of Scan Results
Standard Uptake Value Ratio (SUVr) by amyloid status 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: 75 minutes post dose administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amyloid Positive | Quantitative Evaluation of Scan Results | 1.0414 standardized uptake value ratio (SUVr) | Standard Deviation 0.04165 |
| Amyloid Negative | Quantitative Evaluation of Scan Results | 1.0219 standardized uptake value ratio (SUVr) | Standard Deviation 0.02057 |
| Total | Quantitative Evaluation of Scan Results | 1.0371 standardized uptake value ratio (SUVr) | Standard Deviation 0.03854 |