Alzheimer's Disease
Conditions
Brief summary
This study will evaluate the imaging characteristics of flortaucipir in subjects with a previous flortaucipir scan in order to assess the rate of change of tau deposition over time.
Interventions
DRUGFlortaucipir F18
370 megabecquerel (MBq) IV single-dose
DRUGFlorbetapir F 18
370 megabecquerel (MBq) IV single-dose
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
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Have a previous 18F-AV-1451 brain scan * Can tolerate up to two Positron Emission Tomography (PET) imaging sessions and a Magnetic Resonance Imaging (MRI) scan * Ability to provide informed consent
Exclusion criteria
* Current clinically significant psychiatric disease * Are claustrophobic * Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes * Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer * Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception * Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tau Deposition | baseline scan and at least 6 months after baseline scan | Rate of tau deposition change as measured by flortaucipir standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. |
Countries
United States
Participant flow
Recruitment details
Enrolled subjects who had previously undergone flortaucipir PET (positron emission tomography) scans in other Avid-sponsored (NCT04474405 and NCT01992380) and non-Avid protocols and brought back to the clinic a minimum of 6 months after the initial flortaucipir PET scan for cognitive testing and an additional flortaucipir scan.
Participants by arm
| Arm | Count |
|---|---|
| Cognitively Impaired Clinically-diagnosed AD, MCI, and other dementing disorders (ODD) from the flortaucipir PET scan arm | 16 |
| Healthy Volunteers Healthy Volunteers from the flortaucipir PET scan arm | 21 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated by sponsor | 0 | 7 |
Baseline characteristics
| Characteristic | Cognitively Impaired | Healthy Volunteers | Total |
|---|---|---|---|
| Age, Continuous | 67.6 years STANDARD_DEVIATION 9.15 | 75.3 years STANDARD_DEVIATION 4.98 | 71.9 years STANDARD_DEVIATION 7.98 |
| Amyloid status Negative | 2 Participants | 5 Participants | 7 Participants |
| Amyloid status Positive | 14 Participants | 16 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 21 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 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 | 16 Participants | 19 Participants | 35 Participants |
| Region of Enrollment United States | 16 participants | 21 participants | 37 participants |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 9 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 21 |
| other Total, other adverse events | 1 / 16 | 0 / 21 |
| serious Total, serious adverse events | 0 / 16 | 0 / 21 |
Outcome results
Primary
Change in Tau Deposition
Rate of tau deposition change as measured by flortaucipir standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Time frame: baseline scan and at least 6 months after baseline scan
Population: Amyloid positive and negative row n's reflect the subgroup counts.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitively Impaired | Change in Tau Deposition | Overall | 0.0347 standardized uptake value ratio (SUVr) | Standard Deviation 0.047 |
| Cognitively Impaired | Change in Tau Deposition | Amyloid Negative | 0.0364 standardized uptake value ratio (SUVr) | Standard Deviation 0.082 |
| Cognitively Impaired | Change in Tau Deposition | Amyloid Positive | 0.0345 standardized uptake value ratio (SUVr) | Standard Deviation 0.045 |
| Healthy Volunteers | Change in Tau Deposition | Overall | -0.0008 standardized uptake value ratio (SUVr) | Standard Deviation 0.013 |
| Healthy Volunteers | Change in Tau Deposition | Amyloid Negative | -0.0026 standardized uptake value ratio (SUVr) | Standard Deviation 0.013 |
| Healthy Volunteers | Change in Tau Deposition | Amyloid Positive | -0.0002 standardized uptake value ratio (SUVr) | Standard Deviation 0.013 |
Comparison: Overall change from baseline between groups. Test compared slopes of cognitively impaired (CI) vs healthy volunteers (HV). As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were the different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.p-value: 0.2837ANCOVA
Comparison: Change from baseline between groups for amyloid negative only. Test compared slopes of CI vs HV. As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.p-value: 0.9276ANCOVA
Comparison: Change from baseline between groups for amyloid positive only. Test compared slopes of CI vs HV. As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.p-value: 0.6324ANCOVA