Trial Outcomes & Findings for A Study of 18F-AV-45 in Alzheimer's Disease (AD) and Healthy Volunteers (NCT NCT01565343)
NCT ID: NCT01565343
Last Updated: 2012-05-10
Results Overview
Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
50-70 min after injection
Results posted on
2012-05-10
Participant Flow
Participant milestones
| Measure |
AD Subjects
Male or female subjects \> 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
|
AD Subjects: Slow vs. Fast Bolus Group
Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (\< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
|
Control Subjects
Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
4
|
10
|
|
Overall Study
COMPLETED
|
10
|
4
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
AD Subjects
Male or female subjects \> 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
|
AD Subjects: Slow vs. Fast Bolus Group
Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (\< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
|
Control Subjects
Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
|
|---|---|---|---|
|
Overall Study
Administrative decision/technical issues
|
1
|
0
|
0
|
Baseline Characteristics
A Study of 18F-AV-45 in Alzheimer's Disease (AD) and Healthy Volunteers
Baseline characteristics by cohort
| Measure |
AD Subjects
n=11 Participants
Male or female subjects \> 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
|
AD Subjects: Slow vs. Fast Bolus Group
n=4 Participants
Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (\< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
|
Control Subjects
n=10 Participants
Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
69.7 years
STANDARD_DEVIATION 10.66 • n=5 Participants
|
79.0 years
STANDARD_DEVIATION 3.56 • n=7 Participants
|
44.4 years
STANDARD_DEVIATION 5.64 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 16.30 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
25 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 50-70 min after injectionPopulation: Due to poor subject positioning that resulted in an incomplete brain image on the retest image day, accurate quantitative analysis for one healthy control was not possible, and the subject was excluded from the SUVR-based analyses.
Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.
Outcome measures
| Measure |
AD Subjects
n=10 Participants
Male or female subjects \> 50 years old; probable Alzheimer's Disease) AD according to National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria; Mini-Mental State Examination (MMSE) 10-24
|
Control Subjects
n=9 Participants
Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
|
|---|---|---|
|
Mean Cortical to Cerebellum SUVR
Test (50-70 min)
|
1.416 SUVR
Standard Deviation 0.245
|
1.005 SUVR
Standard Deviation 0.055
|
|
Mean Cortical to Cerebellum SUVR
Retest (50-70 min)
|
1.407 SUVR
Standard Deviation 0.269
|
1.007 SUVR
Standard Deviation 0.061
|
Adverse Events
AD Subjects
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AD Subjects: Slow vs. Fast Bolus Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Subjects
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AD Subjects
n=11 participants at risk
Male or female subjects \> 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
|
AD Subjects: Slow vs. Fast Bolus Group
n=4 participants at risk
Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (\< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
|
Control Subjects
n=10 participants at risk
Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
|
|---|---|---|---|
|
Cardiac disorders
SUPRAVENTRICULAR EXTRASYSTOLES
|
9.1%
1/11 • Number of events 1 • 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%
0/10 • AEs reported within 7 days of injection. SAEs reported within 30 days of injection.
|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
9.1%
1/11 • Number of events 1 • 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%
0/10 • AEs reported within 7 days of injection. SAEs reported within 30 days of injection.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/11 • 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.
|
10.0%
1/10 • 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