Trial Outcomes & Findings for Imaging Inflammation in Alzheimer's Disease With 11C-ER176 (NCT NCT03744312)
NCT ID: NCT03744312
Last Updated: 2025-04-17
Results Overview
Total distribution volume reflects the amount of TSPO (the inflammatory protein that 11C-ER176 sticks to) in the brain. This measure requires arterial blood sampling.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to one year from baseline
Results posted on
2025-04-17
Participant Flow
Participant milestones
| Measure |
Cognitive Impairment
Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia)
11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease.
Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease.
|
No Cognitive Impairment
Healthy Controls
11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease.
Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
|
Overall Study
COMPLETED
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Cognitive Impairment
Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia)
11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease.
Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease.
|
No Cognitive Impairment
Healthy Controls
11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease.
Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Screen fail
|
0
|
1
|
Baseline Characteristics
Imaging Inflammation in Alzheimer's Disease With 11C-ER176
Baseline characteristics by cohort
| Measure |
Cognitive Impairment
n=6 Participants
Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia)
11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease.
Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease.
|
No Cognitive Impairment
n=1 Participants
Healthy Controls
11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease.
Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 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
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 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
|
0 Participants
n=7 Participants
|
0 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
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 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
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to one year from baselinePopulation: Data is reflective of those with blood sampling only: 4 out of 6 cognitive impairment participants and 1 out of 1 no cognitive impairment participant. All 7 completers have 11C-ER176 imaging but only 5 have arterial blood sampling and therefore a Total Distribution Volume.
Total distribution volume reflects the amount of TSPO (the inflammatory protein that 11C-ER176 sticks to) in the brain. This measure requires arterial blood sampling.
Outcome measures
| Measure |
Cognitive Impairment
n=4 Participants
Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia)
11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease.
Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease.
|
No Cognitive Impairment
n=1 Participants
Healthy Controls
11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease.
Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease.
|
|---|---|---|
|
11C-ER176 Total Distribution Volume
|
6.27 mL/cm^3
Interval 3.03 to 8.8
|
9.32 mL/cm^3
Interval 9.32 to 9.32
|
SECONDARY outcome
Timeframe: Up to one year from baselinePopulation: Data is analyzed for completers only: 6 out of 6 cognitive impairment participants and 1 out of 1 no cognitive impairment participant. Completers here meaning they have 11C-ER176 imaging and SUVRs.
The standardize uptake value ratio is the concentration of radioactivity measured from the 11C-ER176 positron emission tomography (PET) scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region). This is a simplified quantification technique compared to the Total Distribution Volume, but is linearly related to it. Higher values indicate more neuroinflammation.
Outcome measures
| Measure |
Cognitive Impairment
n=6 Participants
Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia)
11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease.
Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease.
|
No Cognitive Impairment
n=1 Participants
Healthy Controls
11C-ER176: 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease.
Florbetaben: Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease.
|
|---|---|---|
|
11C-ER176 Standardized Uptake Value Ratio
|
1.19 uptake value ratio
Interval 1.1 to 1.38
|
1.22 uptake value ratio
Interval 1.22 to 1.22
|
Adverse Events
Cognitive Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Cognitive Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place