Trial Outcomes & Findings for Imaging Inflammation in Alzheimer's Disease (NCT NCT02831283)
NCT ID: NCT02831283
Last Updated: 2025-03-05
Results Overview
In vivo quantification radioligand binding to TSPO expression on microglia in the brain, reported as standardized uptake value ratio (SUVR).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Up to 1 year from screening
Results posted on
2025-03-05
Participant Flow
Participant milestones
| Measure |
Amyloid-positive With Cognitive Impairment (AD)
Amyloid-positive patients who already have cognitive impairment at the time of enrollment
|
Amyloid-positive Without Impairment (Preclinical AD)
Cognitively normal subjects who are amyloid-positive
|
Amyloid-negative With Cognitive Impairment
Participants with cognitive impairment due to suspected non-AD pathophysiology
|
Amyloid-negative Without Impairment (Normal Aging)
Cognitively normal subjects who are amyloid-negative on PET and lack signs of neurodegeneration from other biomarkers
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
8
|
11
|
17
|
|
Overall Study
COMPLETED
|
24
|
8
|
11
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imaging Inflammation in Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Amyloid-positive With Cognitive Impairment (AD)
n=24 Participants
Amyloid-positive patients who already have cognitive impairment at the time of enrollment
|
Amyloid-positive Without Impairment (Preclinical AD)
n=8 Participants
Cognitively normal subjects who are amyloid-positive
|
Amyloid-negative With Cognitive Impairment
n=11 Participants
Participants with cognitive impairment due to suspected non-AD pathophysiology
|
Amyloid-negative Without Impairment (Normal Aging)
n=17 Participants
Cognitively normal subjects who are amyloid-negative on PET and lack signs of neurodegeneration from other biomarkers
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
73.8 years
STANDARD_DEVIATION 3.1 • n=7 Participants
|
75.8 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
67.6 years
STANDARD_DEVIATION 3.8 • n=4 Participants
|
68.8 years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
54 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
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 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
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
51 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
|
PRIMARY outcome
Timeframe: Up to 1 year from screeningIn vivo quantification radioligand binding to TSPO expression on microglia in the brain, reported as standardized uptake value ratio (SUVR).
Outcome measures
| Measure |
Amyloid-positive With Cognitive Impairment (AD)
n=24 Participants
Amyloid-positive patients who already have cognitive impairment at the time of enrollment
|
Amyloid-positive Without Impairment (Preclinical AD)
n=8 Participants
Cognitively normal subjects who are amyloid-positive
|
Amyloid-negative With Cognitive Impairment
n=11 Participants
Participants with cognitive impairment due to suspected non-AD pathophysiology
|
Amyloid-negative Without Impairment (Normal Aging)
n=17 Participants
Cognitively normal subjects who are amyloid-negative on PET and lack signs of neurodegeneration from other biomarkers
|
|---|---|---|---|---|
|
11C-PBR28 Binding
|
1.25 SUVR
Standard Deviation 0.18
|
1.15 SUVR
Standard Deviation 0.16
|
1.16 SUVR
Standard Deviation 0.16
|
1.02 SUVR
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: Up to 1 year from screeningIn vivo quantification of radioligand binding to Amyloid-Beta protein in the brain, reported as standardized uptake value ratio (SUVR).
Outcome measures
| Measure |
Amyloid-positive With Cognitive Impairment (AD)
n=24 Participants
Amyloid-positive patients who already have cognitive impairment at the time of enrollment
|
Amyloid-positive Without Impairment (Preclinical AD)
n=8 Participants
Cognitively normal subjects who are amyloid-positive
|
Amyloid-negative With Cognitive Impairment
n=11 Participants
Participants with cognitive impairment due to suspected non-AD pathophysiology
|
Amyloid-negative Without Impairment (Normal Aging)
n=17 Participants
Cognitively normal subjects who are amyloid-negative on PET and lack signs of neurodegeneration from other biomarkers
|
|---|---|---|---|---|
|
18F-Florbetaben Binding
|
1.64 SUVR
Standard Deviation 0.18
|
1.51 SUVR
Standard Deviation 0.14
|
1.17 SUVR
Standard Deviation 0.14
|
1.12 SUVR
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Up to 1 year from screeningPopulation: Some participants did not wish to do this procedure, so data was not collected from these participants.
Protein analysis of cerebral spinal fluid.
Outcome measures
| Measure |
Amyloid-positive With Cognitive Impairment (AD)
n=12 Participants
Amyloid-positive patients who already have cognitive impairment at the time of enrollment
|
Amyloid-positive Without Impairment (Preclinical AD)
n=4 Participants
Cognitively normal subjects who are amyloid-positive
|
Amyloid-negative With Cognitive Impairment
n=3 Participants
Participants with cognitive impairment due to suspected non-AD pathophysiology
|
Amyloid-negative Without Impairment (Normal Aging)
n=5 Participants
Cognitively normal subjects who are amyloid-negative on PET and lack signs of neurodegeneration from other biomarkers
|
|---|---|---|---|---|
|
Cerebral Spinal Fluid (CSF) Biomarkers
|
3.14 ng/mL
Standard Deviation 1.69
|
4.21 ng/mL
Standard Deviation 1.74
|
3.26 ng/mL
Standard Deviation 2.99
|
2.05 ng/mL
Standard Deviation 0.57
|
Adverse Events
Amyloid-positive With Cognitive Impairment (AD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Amyloid-positive Without Impairment (Preclinical AD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Amyloid-negative With Cognitive Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Amyloid-negative Without Impairment (Normal Aging)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amyloid-positive With Cognitive Impairment (AD)
n=24 participants at risk
Amyloid-positive patients who already have cognitive impairment at the time of enrollment
|
Amyloid-positive Without Impairment (Preclinical AD)
n=8 participants at risk
Cognitively normal subjects who are amyloid-positive
|
Amyloid-negative With Cognitive Impairment
n=11 participants at risk
Participants with cognitive impairment due to suspected non-AD pathophysiology
|
Amyloid-negative Without Impairment (Normal Aging)
n=17 participants at risk
Cognitively normal subjects who are amyloid-negative on PET and lack signs of neurodegeneration from other biomarkers
|
|---|---|---|---|---|
|
General disorders
Soreness at IV injection site
|
0.00%
0/24 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
5.9%
1/17 • Up to 1 year
|
|
General disorders
Headache
|
0.00%
0/24 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
5.9%
1/17 • Up to 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place