Trial Outcomes & Findings for Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease (NCT NCT04468347)
NCT ID: NCT04468347
Last Updated: 2020-09-25
Results Overview
Flortaucipir PET cortical weighted average 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
COMPLETED
Study phase
PHASE1
Target enrollment
89 participants
Primary outcome timeframe
baseline scan
Results posted on
2020-09-25
Participant Flow
Enrollment occurred between Oct 2014 and Feb 2018 from the Australian Imaging, Biomarker \& Lifestyle Flagship Study of Ageing (AIBL)
Participant milestones
| Measure |
Alzheimer's Disease (AD)
Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Mild Cognitive Impairment (MCI)
Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Subjective Memory Complainers (SMC)
Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
|
Cognitively Normal (CN)
Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
11
|
47
|
25
|
|
Overall Study
Baseline Flortacuipir PET Scan
|
5
|
11
|
45
|
25
|
|
Overall Study
COMPLETED
|
4
|
10
|
41
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
6
|
4
|
Reasons for withdrawal
| Measure |
Alzheimer's Disease (AD)
Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Mild Cognitive Impairment (MCI)
Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Subjective Memory Complainers (SMC)
Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
|
Cognitively Normal (CN)
Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Alzheimer's Disease (AD)
n=5 Participants
Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Mild Cognitive Impairment (MCI)
n=11 Participants
Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Subjective Memory Complainers (SMC)
n=45 Participants
Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
|
Cognitively Normal (CN)
n=25 Participants
Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
76.2 years
STANDARD_DEVIATION 6.53 • n=5 Participants
|
74.3 years
STANDARD_DEVIATION 5.82 • n=7 Participants
|
77 years
STANDARD_DEVIATION 7.43 • n=5 Participants
|
72.9 years
STANDARD_DEVIATION 4.67 • n=4 Participants
|
75.4 years
STANDARD_DEVIATION 6.64 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
41 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
86 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
85 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=5 Participants
|
11 participants
n=7 Participants
|
45 participants
n=5 Participants
|
25 participants
n=4 Participants
|
86 participants
n=21 Participants
|
|
Mini Mental Status Exam (MMSE)
|
22.6 units on a scale
STANDARD_DEVIATION 3.21 • n=5 Participants
|
25.5 units on a scale
STANDARD_DEVIATION 2.84 • n=7 Participants
|
28 units on a scale
STANDARD_DEVIATION 1.66 • n=5 Participants
|
28.6 units on a scale
STANDARD_DEVIATION 0.99 • n=4 Participants
|
27.5 units on a scale
STANDARD_DEVIATION 2.35 • n=21 Participants
|
PRIMARY outcome
Timeframe: baseline scanPopulation: Inclusion in this analysis required that the subject's flortaucipir scan was analyzable for SUVr (1 AD, 1 MCI, 5 SMC, and 3 CN were not analyzable)
Flortaucipir PET cortical weighted average 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 |
Alzheimer's Disease (AD)
n=4 Participants
Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Mild Cognitive Impairment (MCI)
n=10 Participants
Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Objectively Impaired
n=14 Participants
Combined AD and MCI group
|
Subjective Memory Complainers (SMC)
n=40 Participants
Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
|
Cognitively Normal (CN)
n=22 Participants
Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Non-objectively Compared
n=62 Participants
Combined SMC and CN groups
|
|---|---|---|---|---|---|---|
|
Flortaucipir PET Imaging (Quantitative)
|
1.31 standardized uptake value ratio (SUVr)
Standard Error 0.059
|
1.13 standardized uptake value ratio (SUVr)
Standard Error 0.033
|
1.15 standardized uptake value ratio (SUVr)
Standard Error 0.031
|
1.08 standardized uptake value ratio (SUVr)
Standard Error 0.016
|
1.04 standardized uptake value ratio (SUVr)
Standard Error 0.028
|
1.07 standardized uptake value ratio (SUVr)
Standard Error 0.015
|
PRIMARY outcome
Timeframe: baseline scanPopulation: Rows display flortaucipir scan results by subjects who were amyloid positive and amyloid negative at baseline
Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with Advanced (τAD++) scans were analyzed vs. the combined Moderate and Not AD pattern groups (τAD+/τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B (\[C-11\] PiB) PET results available from the parent AIBL study.
Outcome measures
| Measure |
Alzheimer's Disease (AD)
n=5 Participants
Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Mild Cognitive Impairment (MCI)
n=11 Participants
Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Objectively Impaired
n=45 Participants
Combined AD and MCI group
|
Subjective Memory Complainers (SMC)
n=25 Participants
Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
|
Cognitively Normal (CN)
Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Non-objectively Compared
Combined SMC and CN groups
|
|---|---|---|---|---|---|---|
|
Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
Amyloid Positive · Advanced AD Scan Pattern (τAD++)
|
2 Participants
|
3 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
Amyloid Positive · Not Advanced AD Pattern
|
2 Participants
|
2 Participants
|
11 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
Amyloid Negative · Advanced AD Scan Pattern (τAD++)
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
Amyloid Negative · Not Advanced AD Pattern
|
0 Participants
|
6 Participants
|
22 Participants
|
20 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline scanPopulation: Rows display flortaucipir scan results by subjects who were amyloid positive and amyloid negative at baseline.
Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with AD Pattern scans (Advanced \[τAD++\] and Moderate \[τAD+\] Scan Pattern) were combined vs. the Not AD pattern group (τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B (\[C-11\] PiB) PET results available from the parent AIBL study.
Outcome measures
| Measure |
Alzheimer's Disease (AD)
n=5 Participants
Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Mild Cognitive Impairment (MCI)
n=11 Participants
Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Objectively Impaired
n=45 Participants
Combined AD and MCI group
|
Subjective Memory Complainers (SMC)
n=25 Participants
Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
|
Cognitively Normal (CN)
Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Non-objectively Compared
Combined SMC and CN groups
|
|---|---|---|---|---|---|---|
|
Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
Amyloid Negative · AD Pattern Scan (Advanced or Moderate)
|
1 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
Amyloid Positive · AD Pattern Scan (Advanced or Moderate)
|
2 Participants
|
4 Participants
|
11 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
Amyloid Positive · Not AD Pattern Scan
|
2 Participants
|
1 Participants
|
9 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
Amyloid Negative · Not AD Pattern Scan
|
0 Participants
|
6 Participants
|
19 Participants
|
20 Participants
|
—
|
—
|
Adverse Events
Alzheimer's Disease (AD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mild Cognitive Impairment (MCI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subjective Memory Complainers (SMC)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cognitively Normal (CN)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alzheimer's Disease (AD)
n=5 participants at risk
Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Mild Cognitive Impairment (MCI)
n=11 participants at risk
Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
|
Subjective Memory Complainers (SMC)
n=45 participants at risk
Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
|
Cognitively Normal (CN)
n=25 participants at risk
Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
|
|---|---|---|---|---|
|
Nervous system disorders
headache
|
0.00%
0/5 • 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%
0/11 • 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.
|
2.2%
1/45 • 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%
0/25 • 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.
|
|
Skin and subcutaneous tissue disorders
dermatitis contact
|
0.00%
0/5 • 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%
0/11 • 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%
0/45 • 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.
|
4.0%
1/25 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60