Trial Outcomes & Findings for A Study of Two Doses of 18F-AV-45 in Alzheimer's Disease and Healthy Volunteers (NCT NCT01565330)
NCT ID: NCT01565330
Last Updated: 2012-06-18
Results Overview
Visual evaluation of image quality by nuclear medicine specialist blinded to dose and clinical information; reported on a 5-point scale (5=excellent and 1=poor).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
0-90 min after injection
Results posted on
2012-06-18
Participant Flow
Participant milestones
| Measure |
111 MBq (3 mCi) AD Group
Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
|
111 MBq (3 mCi) Control Group
Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
|
370 MBq (10 mCi) AD Group
Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
|
370 MBq (10 mCi) Control Group
Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
4
|
7
|
|
Overall Study
COMPLETED
|
5
|
4
|
4
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Two Doses of 18F-AV-45 in Alzheimer's Disease and Healthy Volunteers
Baseline characteristics by cohort
| Measure |
111 MBq (3 mCi) AD Group
n=5 Participants
Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
|
111 MBq (3 mCi) Control Group
n=4 Participants
Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
|
370 MBq (10 mCi) AD Group
n=4 Participants
Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
|
370 MBq (10 mCi) Control Group
n=7 Participants
Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
74.8 years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 6.73 • n=7 Participants
|
76.8 years
STANDARD_DEVIATION 10.24 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 6.88 • n=4 Participants
|
59.4 years
STANDARD_DEVIATION 17.14 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
7 participants
n=4 Participants
|
20 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0-90 min after injectionPopulation: One subject in the 370 MBq (10 mCi) AD Group did not complete all imaging time periods
Visual evaluation of image quality by nuclear medicine specialist blinded to dose and clinical information; reported on a 5-point scale (5=excellent and 1=poor).
Outcome measures
| Measure |
111 MBq (3 mCi) AD Group
n=5 Participants
Subjects with Alzheimer's Disease (AD) who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
|
111 MBq (3 mCi) Control Group
n=4 Participants
Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
|
370 MBq (10 mCi) AD Group
n=4 Participants
Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
|
370 MBq (10 mCi) Control Group
n=7 Participants
Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
|
|---|---|---|---|---|
|
Florbetapir-PET Scan Quality
1 - Poor
|
0 florbetapir scans
|
0 florbetapir scans
|
0 florbetapir scans
|
0 florbetapir scans
|
|
Florbetapir-PET Scan Quality
2
|
1 florbetapir scans
|
1 florbetapir scans
|
0 florbetapir scans
|
0 florbetapir scans
|
|
Florbetapir-PET Scan Quality
3
|
1 florbetapir scans
|
3 florbetapir scans
|
2 florbetapir scans
|
4 florbetapir scans
|
|
Florbetapir-PET Scan Quality
4
|
3 florbetapir scans
|
0 florbetapir scans
|
2 florbetapir scans
|
3 florbetapir scans
|
|
Florbetapir-PET Scan Quality
5 - Excellent
|
0 florbetapir scans
|
0 florbetapir scans
|
0 florbetapir scans
|
0 florbetapir scans
|
SECONDARY outcome
Timeframe: 0-90 min after injectionStandardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.
Outcome measures
| Measure |
111 MBq (3 mCi) AD Group
n=5 Participants
Subjects with Alzheimer's Disease (AD) who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
|
111 MBq (3 mCi) Control Group
n=4 Participants
Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
|
370 MBq (10 mCi) AD Group
n=4 Participants
Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
|
370 MBq (10 mCi) Control Group
n=7 Participants
Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
|
|---|---|---|---|---|
|
Mean Cortical to Cerebellum SUVR
|
1.781 SUVR
Standard Deviation 0.217
|
0.968 SUVR
Standard Deviation 0.050
|
1.658 SUVR
Standard Deviation 0.288
|
0.988 SUVR
Standard Deviation 0.093
|
Adverse Events
111 MBq (3 mCi) AD Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
111 MBq (3 mCi) Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
370 MBq (10 mCi) AD Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
370 MBq (10 mCi) Control Group
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 |
111 MBq (3 mCi) AD Group
n=5 participants at risk
Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
|
111 MBq (3 mCi) Control Group
n=4 participants at risk
Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
|
370 MBq (10 mCi) AD Group
n=4 participants at risk
Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
|
370 MBq (10 mCi) Control Group
n=7 participants at risk
Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
|
|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/5 • AEs reported within 7 days of injection; SAEs reported within 30 days of injection.
|
0.00%
0/4 • AEs reported within 7 days of injection; SAEs reported within 30 days of injection.
|
0.00%
0/4 • AEs reported within 7 days of injection; SAEs reported within 30 days of injection.
|
14.3%
1/7 • Number of events 1 • AEs reported within 7 days of injection; SAEs reported within 30 days of injection.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/5 • AEs reported within 7 days of injection; SAEs reported within 30 days of injection.
|
0.00%
0/4 • AEs reported within 7 days of injection; SAEs reported within 30 days of injection.
|
0.00%
0/4 • AEs reported within 7 days of injection; SAEs reported within 30 days of injection.
|
14.3%
1/7 • Number of events 1 • AEs reported within 7 days of injection; SAEs reported within 30 days of injection.
|
|
General disorders
INJECTION SITE IRRITATION
|
0.00%
0/5 • AEs reported within 7 days of injection; SAEs reported within 30 days of injection.
|
0.00%
0/4 • AEs reported within 7 days of injection; SAEs reported within 30 days of injection.
|
0.00%
0/4 • AEs reported within 7 days of injection; SAEs reported within 30 days of injection.
|
14.3%
1/7 • Number of events 1 • AEs reported within 7 days of injection; SAEs reported within 30 days of injection.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60