A Phase 2 interventional study of Flortaucipir F18 and PET Scan in Alzheimer's Disease, sponsored by Avid Radiopharmaceuticals. Completed at 22 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2020-08-24.
Sponsored by Avid Radiopharmaceuticals · Phase 2, Interventional, and Diagnostic
This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F 18 uptake over time.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 79 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Avid Radiopharmaceuticals is the lead sponsor of 54 studies on the registry; none are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Flortaucipir F18 · Procedure: PET Scan
370 megabecquerel (MBq) IV single-dose
Also known as: T807, 18F-AV-1451
positron emission tomography (PET) scan
Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status
Change in flortaucipir standardized uptake value ratio (SUVr) over 18 months. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. A positive change in SUVr represents an increase in tau deposition in the brain. Change = 18 month SUVr - baseline SUVr obtained in Study A05.
Time frame: 18 months
Enrolled between Aug 2016 and Aug 2017. The only subjects eligible were those who completed the Confirmatory Phase of Study A05 (NCT02016560).
| Milestone | AD Subjects | MCI Subjects |
|---|---|---|
| Started | 25 | 54 |
| Completed | 25 | 54 |
| Not completed | 0 | 0 |
Change in flortaucipir standardized uptake value ratio (SUVr) over 18 months. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. A positive change in SUVr represents an increase in tau deposition in the brain. Change = 18 month SUVr - baseline SUVr obtained in Study A05.
| standardized uptake value ratio (SUVr) | AD Aβ+ Subjects | AD Aβ- Subjects | MCI Aβ+ Subjects | MCI Aβ- Subjects |
|---|---|---|---|---|
| Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status | 0.0205 ± 0.01871 | -0.0912 ± 0.03619 | 0.0352 ± 0.01185 | -0.0124 ± 0.01185 |
Collected over 48 hours after study drug administration. Non-serious events are listed at a 0.5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MCI Subjects | 0/54 (0%) | 0/54 (0%) | 2/54 (3.7%) |
| AD Subjects | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Event | MCI Subjects | AD Subjects |
|---|---|---|
| injection site painGeneral disorders | 1/54 | 0/25 |
| dizzinessNervous system disorders | 1/54 | 0/25 |
| flushingVascular disorders | 1/54 | 0/25 |
| Age, Continuous(years) | AD Subjects | MCI Subjects | Total |
|---|---|---|---|
| Mean | 73.8 ± 10.63 | 73.2 ± 9.1 | 73.4 ± 9.54 |
| Sex: Female, Male(Participants) | AD Subjects | MCI Subjects | Total |
|---|---|---|---|
| Female | 9 | 22 | 31 |
| Male | 16 | 32 | 48 |
| Ethnicity (NIH/OMB)(Participants) | AD Subjects | MCI Subjects | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 3 | 4 |
| Not Hispanic or Latino | 24 | 51 | 75 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | AD Subjects | MCI Subjects | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 3 | 3 |
| White | 25 | 51 | 76 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | AD Subjects | MCI Subjects | Total |
|---|---|---|---|
| United States | 25 | 54 | 79 |
| MMSE(units on a scale) | AD Subjects | MCI Subjects | Total |
|---|---|---|---|
| Mean | 23.7 ± 2.39 | 25.9 ± 1.48 | 25.2 ± 2.06 |
| CDR-SB(units on a scale) | AD Subjects | MCI Subjects | Total |
|---|---|---|---|
| Mean | 4.8 ± 1.53 | 2.6 ± 1.91 | 3.3 ± 2.05 |
| Amyloid status(Participants) | AD Subjects | MCI Subjects | Total |
|---|---|---|---|
| Amyloid positive | 19 | 26 | 45 |
| Amyloid Negative | 6 | 28 | 34 |
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Avid Radiopharmaceuticals