Trial Outcomes & Findings for Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls. (NCT NCT01890343)
NCT ID: NCT01890343
Last Updated: 2014-09-29
Results Overview
Four readers blinded to all clinical information classified florbetapir Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read classification is presented as either positive, negative or tied.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
50-60 min after injection
Results posted on
2014-09-29
Participant Flow
34 subjects were enrolled in the trial but 6 subjects did not receive florbetapir and were not included in the Overall Study period.
Participant milestones
| Measure |
Frontotemporal Disorder
Subjects with frontotemporal disorder (FTD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.
|
Cognitively Normal
Cognitively normal (CN) subjects.
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
|
Alzheimer's Disease
Subjects with Alzheimer's disease (AD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.
Baseline characteristics by cohort
| Measure |
Frontotemporal Disorder
n=8 Participants
Subjects with frontotemporal disorder (FTD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.
|
Cognitively Normal
n=10 Participants
Cognitively normal (CN) subjects.
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
|
Alzheimer's Disease
n=10 Participants
Subjects with Alzheimer's disease (AD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 9.62 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 4.99 • n=7 Participants
|
62.6 years
STANDARD_DEVIATION 4.35 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 6.22 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
28 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 50-60 min after injectionFour readers blinded to all clinical information classified florbetapir Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read classification is presented as either positive, negative or tied.
Outcome measures
| Measure |
Frontotemporal Disorder
n=8 Participants
Subjects with frontotemporal disorder (FTD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.
|
Cognitively Normal
n=10 Participants
Cognitively normal (CN) subjects.
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
|
Alzheimer's Disease
n=10 Participants
Subjects with Alzheimer's disease (AD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
|
|---|---|---|---|
|
Qualitative Amyloid Image Assessment
Positive Scan
|
2 participants
|
1 participants
|
8 participants
|
|
Qualitative Amyloid Image Assessment
Negative Scan
|
4 participants
|
8 participants
|
2 participants
|
|
Qualitative Amyloid Image Assessment
Tie
|
2 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 50-60 minutes after injectionThe effect of diagnostic group on mean total cortical grey matter florbetapir binding relative to cerebellar cortex is presented as standard uptake value ratios (SUVr).
Outcome measures
| Measure |
Frontotemporal Disorder
n=8 Participants
Subjects with frontotemporal disorder (FTD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.
|
Cognitively Normal
n=10 Participants
Cognitively normal (CN) subjects.
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
|
Alzheimer's Disease
n=10 Participants
Subjects with Alzheimer's disease (AD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
|
|---|---|---|---|
|
Quantitative Amyloid Image Assessment
|
1.25 SUVr
Standard Deviation 0.36
|
1.29 SUVr
Standard Deviation 0.11
|
1.77 SUVr
Standard Deviation 0.38
|
Adverse Events
Frontotemporal Disorder
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cognitively Normal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alzheimer's Disease
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 |
Frontotemporal Disorder
n=8 participants at risk
Subjects with frontotemporal disorder (FTD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.
|
Cognitively Normal
n=10 participants at risk
Cognitively normal (CN) subjects.
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
|
Alzheimer's Disease
n=10 participants at risk
Subjects with Alzheimer's disease (AD).
florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • 7 days
|
0.00%
0/10 • 7 days
|
10.0%
1/10 • Number of events 1 • 7 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • Number of events 1 • 7 days
|
0.00%
0/10 • 7 days
|
0.00%
0/10 • 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60