Trial Outcomes & Findings for A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects (NCT NCT01992380)
NCT ID: NCT01992380
Last Updated: 2020-09-07
Results Overview
Evaluate test-retest reproducibility of flortaucipir for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
80-100 minutes postdose
Results posted on
2020-09-07
Participant Flow
Enrollment between Nov 2013 and May 2014
Participant milestones
| Measure |
Healthy Volunteer Subjects
Healthy males or females 50 years or older with no evidence of cognitive impairment
Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Brain PET scan: positron emission tomography (PET) scan of the brain
|
MCI Subjects
Subjects 50 years or older with mild cognitive impairment (MCI)
Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Brain PET scan: positron emission tomography (PET) scan of the brain
|
Probable AD Subjects
Subjects 50 years or older with probable Alzheimer's Disease (AD)
Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Brain PET scan: positron emission tomography (PET) scan of the brain
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
10
|
|
Overall Study
COMPLETED
|
6
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects
Baseline characteristics by cohort
| Measure |
Healthy Volunteer Subjects
n=6 Participants
Healthy males or females 50 years or older with no evidence of cognitive impairment
Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Brain PET scan: positron emission tomography (PET) scan of the brain
|
MCI Subjects
n=8 Participants
Subjects 50 years or older with mild cognitive impairment (MCI)
Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Brain PET scan: positron emission tomography (PET) scan of the brain
|
Probable AD Subjects
n=10 Participants
Subjects 50 years or older with probable Alzheimer's Disease (AD)
Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Brain PET scan: positron emission tomography (PET) scan of the brain
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
70.3 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
74.4 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
70.1 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Mini Mental Status Exam (MMSE)
|
29.7 units on a scale
STANDARD_DEVIATION 0.52 • n=5 Participants
|
28.3 units on a scale
STANDARD_DEVIATION 1.58 • n=7 Participants
|
23.9 units on a scale
STANDARD_DEVIATION 4.58 • n=5 Participants
|
26.8 units on a scale
STANDARD_DEVIATION 3.95 • n=4 Participants
|
PRIMARY outcome
Timeframe: 80-100 minutes postdosePopulation: All subjects with a valid test and re-test scan. The 80-100 minute scan was not done for one subject in the healthy volunteer group due to technical difficulties with the scanning apparatus
Evaluate test-retest reproducibility of flortaucipir for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects
Outcome measures
| Measure |
All Subjects
n=24 Participants
All study subjects
Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Brain PET scan: positron emission tomography (PET) scan of the brain
|
|---|---|
|
Test-Retest Reproducibility
Test Imaging
|
1.342 standardized uptake value ratio (SUVr)
Standard Deviation 0.341
|
|
Test-Retest Reproducibility
Retest Imaging
|
1.355 standardized uptake value ratio (SUVr)
Standard Deviation 0.309
|
PRIMARY outcome
Timeframe: 110-130 minutes postdoseEvaluate test-retest reproducibility of 18F-AV-1451 for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects
Outcome measures
| Measure |
All Subjects
n=24 Participants
All study subjects
Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Brain PET scan: positron emission tomography (PET) scan of the brain
|
|---|---|
|
Test-Retest Reproducibility
Test Imaging
|
1.459 standardized uptake value ratio (SUVr)
Standard Deviation 0.455
|
|
Test-Retest Reproducibility
Retest Imaging
|
1.457 standardized uptake value ratio (SUVr)
Standard Deviation 0.396
|
Adverse Events
Healthy Volunteer Subjects
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MCI Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Probable AD Subjects
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Volunteer Subjects
n=6 participants at risk
Healthy males or females 50 years or older with no evidence of cognitive impairment
Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Brain PET scan: positron emission tomography (PET) scan of the brain
|
MCI Subjects
n=8 participants at risk
Subjects 50 years or older with mild cognitive impairment (MCI)
Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Brain PET scan: positron emission tomography (PET) scan of the brain
|
Probable AD Subjects
n=10 participants at risk
Subjects 50 years or older with probable Alzheimer's Disease (AD)
Flortaucipir F18: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Brain PET scan: positron emission tomography (PET) scan of the brain
|
|---|---|---|---|
|
Nervous system disorders
dysgeusia
|
16.7%
1/6 • Number of events 1 • End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.
Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to flortaucipir.
|
0.00%
0/8 • End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.
Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to flortaucipir.
|
0.00%
0/10 • End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.
Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to flortaucipir.
|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/6 • End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.
Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to flortaucipir.
|
0.00%
0/8 • End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.
Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to flortaucipir.
|
10.0%
1/10 • Number of events 1 • End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.
Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to flortaucipir.
|
|
Vascular disorders
hypertension
|
0.00%
0/6 • End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.
Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to flortaucipir.
|
0.00%
0/8 • End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.
Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to flortaucipir.
|
20.0%
2/10 • Number of events 2 • End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.
Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to flortaucipir.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60