Trial Outcomes & Findings for Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations (NCT NCT02676843)
NCT ID: NCT02676843
Last Updated: 2019-12-06
Results Overview
Regional tau deposition will be measured as standardized uptake value ratio (SUVR) of 18F-AV-1451. SUVR (80-100 min post-injection) for 18F-AV-1451 will be calculated two ways: 1) using cerebellar crus as a reference region, and 2) using the Parametric Estimation of Reference Signal Intensity (PERSI) method to create individual white matter reference regions. Binding in the inferior temporal lobe/cortex was used as the primary outcome.
COMPLETED
PHASE2
7 participants
Baseline, 12-month follow up
2019-12-06
Participant Flow
Participant milestones
| Measure |
18F-AV-1451
Subjects will receive 18F-AV-1451 by injection, and undergo a Positron Emission Tomography (PET) scan, which will then be qualitatively analyzed to examine tau deposition in the brain.
18F-AV-1451: A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan.
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|---|---|
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Overall Study
STARTED
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7
|
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations
Baseline characteristics by cohort
| Measure |
18F-AV-1451
n=7 Participants
Subjects will receive 18F-AV-1451 by injection, and undergo a Positron Emission Tomography (PET) scan, which will then be qualitatively analyzed to examine tau deposition in the brain.
18F-AV-1451: A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan.
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|---|---|
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Age, Customized
18-21 years
|
0 Participants
n=5 Participants
|
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Age, Customized
22-29 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
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1 Participants
n=5 Participants
|
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Sex: Female, Male
Female
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5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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7 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, 12-month follow upPopulation: 5 out of 7 subjects had data collected and analyzed (evaluable repeat imaging after 12 months).
Regional tau deposition will be measured as standardized uptake value ratio (SUVR) of 18F-AV-1451. SUVR (80-100 min post-injection) for 18F-AV-1451 will be calculated two ways: 1) using cerebellar crus as a reference region, and 2) using the Parametric Estimation of Reference Signal Intensity (PERSI) method to create individual white matter reference regions. Binding in the inferior temporal lobe/cortex was used as the primary outcome.
Outcome measures
| Measure |
18F-AV-1451 - Non-carriers
n=2 Participants
Subjects who are microtubule associated protein tau (MAPT) family non-carriers will receive 18F-AV-1451 by injection, and undergo a Positron Emission Tomography (PET) scan, which will then be qualitatively analyzed to examine tau deposition in the brain.
18F-AV-1451: A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan.
|
18F-AV-1451 - Carriers
n=3 Participants
Subjects who are MAPT family carriers will receive 18F-AV-1451 by injection, and undergo a Positron Emission Tomography (PET) scan, which will then be qualitatively analyzed to examine tau deposition in the brain.
18F-AV-1451: A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan.
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|---|---|---|
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SUVR of 18F-AV-1451
Inferior temporal cortex (Cerebellar crus)
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1.07 standardized uptake value ratio (SUVR)
Interval 0.99 to 1.14
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1.26 standardized uptake value ratio (SUVR)
Interval 1.21 to 1.26
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SUVR of 18F-AV-1451
Inferior temporal cortex (PERSI)
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1.03 standardized uptake value ratio (SUVR)
Interval 1.01 to 1.05
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1.34 standardized uptake value ratio (SUVR)
Interval 1.26 to 1.36
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Adverse Events
18F-AV-1451
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
18F-AV-1451
n=7 participants at risk
Subjects will receive 18F-AV-1451 by injection, and undergo a Positron Emission Tomography (PET) scan, which will then be qualitatively analyzed to examine tau deposition in the brain.
18F-AV-1451: A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan.
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|---|---|
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General disorders
Insomnia
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28.6%
2/7 • Number of events 5 • Up to 2 years
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General disorders
Headache
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28.6%
2/7 • Number of events 5 • Up to 2 years
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place