Trial Outcomes & Findings for Imaging Characteristics of a Follow-up 18F-AV-1451 Scan (NCT NCT02051764)
NCT ID: NCT02051764
Last Updated: 2020-09-07
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
baseline scan and at least 6 months after baseline scan
Results posted on
2020-09-07
Participant Flow
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.
Participant milestones
| Measure |
Cognitively Impaired
Clinically-diagnosed Alzheimer's disease (AD), mild cognitive impairment (MCI), and other dementing disorders (ODD) from the flortaucipir PET scan arm
|
Healthy Volunteers
Male or female subjects ≥50 years of age without cognitive impairment from the flortaucipir PET scan arm
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
28
|
|
Overall Study
COMPLETED
|
16
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
7
|
Reasons for withdrawal
| Measure |
Cognitively Impaired
Clinically-diagnosed Alzheimer's disease (AD), mild cognitive impairment (MCI), and other dementing disorders (ODD) from the flortaucipir PET scan arm
|
Healthy Volunteers
Male or female subjects ≥50 years of age without cognitive impairment from the flortaucipir PET scan arm
|
|---|---|---|
|
Overall Study
Study terminated by sponsor
|
0
|
7
|
Baseline Characteristics
Imaging Characteristics of a Follow-up 18F-AV-1451 Scan
Baseline characteristics by cohort
| Measure |
Cognitively Impaired
n=16 Participants
Clinically-diagnosed AD, MCI, and other dementing disorders (ODD) from the flortaucipir PET scan arm
|
Healthy Volunteers
n=21 Participants
Healthy Volunteers from the flortaucipir PET scan arm
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 9.15 • n=5 Participants
|
75.3 years
STANDARD_DEVIATION 4.98 • n=7 Participants
|
71.9 years
STANDARD_DEVIATION 7.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
21 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Amyloid status
Positive
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Amyloid status
Negative
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline scan and at least 6 months after baseline scanPopulation: Amyloid positive and negative row n's reflect the subgroup counts.
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.
Outcome measures
| Measure |
Cognitively Impaired
n=16 Participants
Clinically-diagnosed AD, MCI, and other dementing disorders (ODD) from the flortaucipir PET scan arm
|
Healthy Volunteers
n=21 Participants
Male or female subjects ≥50 years of age without cognitive impairment from the flortaucipir PET scan arm
|
|---|---|---|
|
Change in Tau Deposition
Overall
|
0.0347 standardized uptake value ratio (SUVr)
Standard Deviation 0.047
|
-0.0008 standardized uptake value ratio (SUVr)
Standard Deviation 0.013
|
|
Change in Tau Deposition
Amyloid Negative
|
0.0364 standardized uptake value ratio (SUVr)
Standard Deviation 0.082
|
-0.0026 standardized uptake value ratio (SUVr)
Standard Deviation 0.013
|
|
Change in Tau Deposition
Amyloid Positive
|
0.0345 standardized uptake value ratio (SUVr)
Standard Deviation 0.045
|
-0.0002 standardized uptake value ratio (SUVr)
Standard Deviation 0.013
|
Adverse Events
Cognitively Impaired
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Healthy Volunteers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cognitively Impaired
n=16 participants at risk
Clinically-diagnosed Alzheimer's disease (AD), mild cognitive impairment (MCI), and other dementing disorders (ODD) from the flortaucipir PET scan arm
|
Healthy Volunteers
n=21 participants at risk
Male or female subjects ≥50 years of age without cognitive impairment from the flortaucipir PET scan arm
|
|---|---|---|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • Administration of study drug until 48 hours post administration
|
0.00%
0/21 • Administration of study drug until 48 hours post administration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Data confidentiality for a period of 5 years following study termination
- Publication restrictions are in place
Restriction type: OTHER