Trial Outcomes & Findings for PET Imaging of Neuroinflammation in Neurodegenerative Diseases Via a Novel Translocator Protein (TSPO) Radioligand (NCT NCT03958630)
NCT ID: NCT03958630
Last Updated: 2024-05-01
Results Overview
Participants underwent brain positron emission tomography (PET) scan with \[11C\]ER176 and standard uptake value (SUV) was measured over 90 minutes and divided by SUV of the cerebellum to determine difference of \[11C\]ER176 brain uptake
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Up to 90 minutes during scan
Results posted on
2024-05-01
Participant Flow
Participant milestones
| Measure |
Healthy Volunteers
Participants underwent brain positron emission tomography (PET) scan with \[11C\]ER176 and/or \[11C\]PIB followed by brain magnetic resonance imaging (MRI)
|
Subjects With Chromosome 9 Open Reading Frame 72 (C9ORF72)
Participants underwent brain positron emission tomography (PET) scan with \[11C\]ER176 and/or \[11C\]PIB followed by brain magnetic resonance imaging (MRI)
|
Subjects With Frontotemporal Dementia (FTD)
Participants underwent brain positron emission tomography (PET) scan with \[11C\]ER176 and/or \[11C\]PIB followed by brain magnetic resonance imaging (MRI)
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
4
|
|
Overall Study
COMPLETED
|
6
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Healthy Volunteers
Participants underwent brain positron emission tomography (PET) scan with \[11C\]ER176 and/or \[11C\]PIB followed by brain magnetic resonance imaging (MRI)
|
Subjects With Chromosome 9 Open Reading Frame 72 (C9ORF72)
Participants underwent brain positron emission tomography (PET) scan with \[11C\]ER176 and/or \[11C\]PIB followed by brain magnetic resonance imaging (MRI)
|
Subjects With Frontotemporal Dementia (FTD)
Participants underwent brain positron emission tomography (PET) scan with \[11C\]ER176 and/or \[11C\]PIB followed by brain magnetic resonance imaging (MRI)
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Withdrawn due to the 2019 pandemic
|
0
|
0
|
1
|
Baseline Characteristics
PET Imaging of Neuroinflammation in Neurodegenerative Diseases Via a Novel Translocator Protein (TSPO) Radioligand
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=6 Participants
Participants underwent brain positron emission tomography (PET) scan with \[11C\]ER176 and/or \[11C\]PIB followed by brain magnetic resonance imaging (MRI)
|
Subjects With Chromosome 9 Open Reading Frame 72 (C9ORF72)
n=3 Participants
Participants underwent brain positron emission tomography (PET) scan with \[11C\]ER176 and/or \[11C\]PIB followed by brain magnetic resonance imaging (MRI)
|
Subjects With Frontotemporal Dementia (FTD)
n=4 Participants
Participants underwent brain positron emission tomography (PET) scan with \[11C\]ER176 and/or \[11C\]PIB followed by brain magnetic resonance imaging (MRI)
|
Total
n=13 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 90 minutes during scanPopulation: All participants who completed the PET scan
Participants underwent brain positron emission tomography (PET) scan with \[11C\]ER176 and standard uptake value (SUV) was measured over 90 minutes and divided by SUV of the cerebellum to determine difference of \[11C\]ER176 brain uptake
Outcome measures
| Measure |
Healthy Volunteers
n=6 Participants
Participants underwent brain positron emission tomography (PET) scan with \[11C\]ER176 and/or \[11C\]PIB followed by brain magnetic resonance imaging (MRI)
|
Subjects With Frontotemporal Dementia (FTD)
n=2 Participants
Participants underwent brain positron emission tomography (PET) scan with \[11C\]ER176 and/or \[11C\]PIB followed by brain magnetic resonance imaging (MRI)
|
Subjects With Chromosome 9 Open Reading Frame 72 (C9ORF72)
n=3 Participants
Participants underwent brain positron emission tomography (PET) scan with \[11C\]ER176 and/or \[11C\]PIB followed by brain magnetic resonance imaging (MRI)
|
|---|---|---|---|
|
Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
Dorsolateral Prefrontal Cortex
|
1.154816988 SUV Ratio (SUVR)
Standard Deviation 0.1068451736460
|
1.243023793 SUV Ratio (SUVR)
Standard Deviation 0.20560563
|
0.936561195 SUV Ratio (SUVR)
Standard Deviation 0.190544723
|
|
Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
Dorsomedial Prefrontal Cortex
|
0.996700383 SUV Ratio (SUVR)
Standard Deviation 0.071340712
|
0.989731836 SUV Ratio (SUVR)
Standard Deviation 0.093928709
|
0.905523672 SUV Ratio (SUVR)
Standard Deviation 0.048246962
|
|
Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
Orbitofrontal Lobe
|
1.217485758 SUV Ratio (SUVR)
Standard Deviation 0.088415727
|
1.267286508 SUV Ratio (SUVR)
Standard Deviation 0.045403115
|
1.047192088 SUV Ratio (SUVR)
Standard Deviation 0.146706043
|
|
Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
Perisylvian Cortex, Left
|
1.143352336 SUV Ratio (SUVR)
Standard Deviation 0.102185733
|
1.132367538 SUV Ratio (SUVR)
Standard Deviation 0.049940532
|
1.029305407 SUV Ratio (SUVR)
Standard Deviation 0.066022192
|
|
Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
Perisylvian Cortex, Right
|
1.090685411 SUV Ratio (SUVR)
Standard Deviation 0.071228603
|
1.112003017 SUV Ratio (SUVR)
Standard Deviation 0.09381086
|
0.941024006 SUV Ratio (SUVR)
Standard Deviation 0.055892402
|
|
Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
Parietal Lobe, Left
|
1.073048863 SUV Ratio (SUVR)
Standard Deviation 0.083878696
|
1.034142945 SUV Ratio (SUVR)
Standard Deviation 0.01253728
|
0.918176888 SUV Ratio (SUVR)
Standard Deviation 0.114668223
|
|
Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
Parietal Lobe, Right
|
1.020202657 SUV Ratio (SUVR)
Standard Deviation 0.069903326
|
1.031347183 SUV Ratio (SUVR)
Standard Deviation 0.03211946
|
0.848570905 SUV Ratio (SUVR)
Standard Deviation 0.190475917
|
|
Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
Medial Temporal Lobe, Left
|
1.08451324 SUV Ratio (SUVR)
Standard Deviation 0.07643309
|
1.064745227 SUV Ratio (SUVR)
Standard Deviation 0.093063402
|
1.032603069 SUV Ratio (SUVR)
Standard Deviation 0.036960689
|
|
Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
Medial Temporal Lobe, Right
|
1.080818839 SUV Ratio (SUVR)
Standard Deviation 0.054571041
|
1.126409887 SUV Ratio (SUVR)
Standard Deviation 0.037945068
|
1.006852539 SUV Ratio (SUVR)
Standard Deviation 0.041618527
|
|
Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
Lateral Temporal Lobe, Left
|
1.000872064 SUV Ratio (SUVR)
Standard Deviation 0.095177072
|
1.009331898 SUV Ratio (SUVR)
Standard Deviation 0.006341876
|
0.928285311 SUV Ratio (SUVR)
Standard Deviation 0.046290454
|
|
Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
Lateral Temporal Lobe, Right
|
0.970093545 SUV Ratio (SUVR)
Standard Deviation 0.056699904
|
0.953890974 SUV Ratio (SUVR)
Standard Deviation 0.022213838
|
0.868920257 SUV Ratio (SUVR)
Standard Deviation 0.052268097
|
|
Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
Temporal Pole, Left
|
1.174033153 SUV Ratio (SUVR)
Standard Deviation 0.144718189
|
1.105735482 SUV Ratio (SUVR)
Standard Deviation 0.006722645
|
0.951727887 SUV Ratio (SUVR)
Standard Deviation 0.184135923
|
|
Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
Temporal Pole, Right
|
1.083264223 SUV Ratio (SUVR)
Standard Deviation 0.089675769
|
1.133115055 SUV Ratio (SUVR)
Standard Deviation 0.117352842
|
0.869347972 SUV Ratio (SUVR)
Standard Deviation 0.213594461
|
|
Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
Occipital Lobe
|
1.054680093 SUV Ratio (SUVR)
Standard Deviation 0.054134358
|
1.029642393 SUV Ratio (SUVR)
Standard Deviation 0.019495596
|
0.971346796 SUV Ratio (SUVR)
Standard Deviation 0.048140098
|
|
Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
Basal Ganglia + Thalamus
|
1.005308052 SUV Ratio (SUVR)
Standard Deviation 0.120193318
|
1.000347379 SUV Ratio (SUVR)
Standard Deviation 0.046553725
|
0.991325953 SUV Ratio (SUVR)
Standard Deviation 0.017050753
|
Adverse Events
Healthy Volunteers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subjects With Chromosome 9 Open Reading Frame 72 (C9ORF72)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subjects With Frontotemporal Dementia (FTD)
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