Trial Outcomes & Findings for Bridging Study of C11 Pittsburgh Compound B (PiB) and F18 Flutemetamol Brain Positron Emission Tomography (PET) (NCT NCT01607476)
NCT ID: NCT01607476
Last Updated: 2017-04-18
Results Overview
The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts. The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
89 participants
Primary outcome timeframe
Approximately one hour after injection of positron emission tomography (PET) drug
Results posted on
2017-04-18
Participant Flow
Participants were recruited from Mayo Clinic in Minnesota.
89 subjects were consented, but 1 subject was a screen failure prior to assignment.
Participant milestones
| Measure |
Alzheimer's Disease
Subjects who have the clinical diagnosis of probable Alzheimer's disease (AD) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR). Interventions include C11 Pittsburgh Compound B (PiB) PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 millicurie (mCi) C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
Cognitive Normal Elderly
Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
Cognitive Normal Young
Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
30
|
33
|
|
Overall Study
COMPLETED
|
24
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
Reasons for withdrawal
| Measure |
Alzheimer's Disease
Subjects who have the clinical diagnosis of probable Alzheimer's disease (AD) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR). Interventions include C11 Pittsburgh Compound B (PiB) PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 millicurie (mCi) C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
Cognitive Normal Elderly
Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
Cognitive Normal Young
Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
Baseline Characteristics
Bridging Study of C11 Pittsburgh Compound B (PiB) and F18 Flutemetamol Brain Positron Emission Tomography (PET)
Baseline characteristics by cohort
| Measure |
Alzheimer's Disease
n=25 Participants
Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).
Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
Cognitive Normal Elderly
n=30 Participants
Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
Cognitive Normal Young
n=33 Participants
Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
Total
n=88 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
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
30 participants
n=7 Participants
|
33 participants
n=5 Participants
|
86 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Approximately one hour after injection of positron emission tomography (PET) drugThe imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts. The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel.
Outcome measures
| Measure |
Alzheimer's Disease
n=24 Participants
Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).
Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
Cognitive Normal Elderly
n=30 Participants
Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
Cognitive Normal Young
n=30 Participants
Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
|---|---|---|---|
|
Global Distribution of C11 PiB in the Brain
|
2.50 standard uptake value ratio
Standard Deviation 0.53
|
1.47 standard uptake value ratio
Standard Deviation 0.28
|
1.23 standard uptake value ratio
Standard Deviation 0.08
|
PRIMARY outcome
Timeframe: Approximately one hour after injection of positron emission tomography (PET) drugThe imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts. The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel.
Outcome measures
| Measure |
Alzheimer's Disease
n=24 Participants
Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).
Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
Cognitive Normal Elderly
n=30 Participants
Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
Cognitive Normal Young
n=30 Participants
Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
|---|---|---|---|
|
Global Distribution of F18 Flutemetamol in the Brain
|
2.49 standard uptake value ratio
Standard Deviation 0.49
|
1.59 standard uptake value ratio
Standard Deviation 0.26
|
1.34 standard uptake value ratio
Standard Deviation 0.09
|
Adverse Events
Alzheimer's Disease
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cognitive Normal Elderly
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cognitive Normal Young
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 |
Alzheimer's Disease
n=24 participants at risk
Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).
Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
Cognitive Normal Elderly
n=30 participants at risk
Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
Cognitive Normal Young
n=30 participants at risk
Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.
C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB
F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol.
|
|---|---|---|---|
|
Eye disorders
Decreased vision
|
0.00%
0/24 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
3.3%
1/30 • Number of events 1 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
3.3%
1/30 • Number of events 1 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
|
Gastrointestinal disorders
Hypoglycemia
|
0.00%
0/24 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
0.00%
0/30 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
3.3%
1/30 • Number of events 1 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
|
Cardiac disorders
Heart palpitations (moderate)
|
0.00%
0/24 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
3.3%
1/30 • Number of events 1 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
0.00%
0/30 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
|
Gastrointestinal disorders
Metallic taste
|
0.00%
0/24 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
3.3%
1/30 • Number of events 1 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
0.00%
0/30 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
|
Musculoskeletal and connective tissue disorders
Leg cramp (mild)
|
0.00%
0/24 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
3.3%
1/30 • Number of events 1 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
0.00%
0/30 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
|
Nervous system disorders
Dizziness (mild)
|
4.2%
1/24 • Number of events 1 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
0.00%
0/30 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
0.00%
0/30 • Participants were followed for adverse events over the 24 hour period after injection with the study drugs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place