Trial Outcomes & Findings for Practice Effects and Amyloid Imaging Using 18F-PIB or Flutemetamol PET and FDG-PET (NCT NCT01202994)
NCT ID: NCT01202994
Last Updated: 2023-05-09
Results Overview
Standardized Uptake Value Ratio on flutemetamol scan will be the imaging marker of Alzheimer's disease pathology.
COMPLETED
PHASE2
27 participants
Imaging occurred during a single session with each subject.
2023-05-09
Participant Flow
Participant milestones
| Measure |
Flute and pe
Participants receive a flutemetamol PET scan and two cognitive testing sessions across one week
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Practice Effects and Amyloid Imaging Using 18F-PIB or Flutemetamol PET and FDG-PET
Baseline characteristics by cohort
| Measure |
Flute and pe
n=27 Participants
Participants receive a flutemetamol PET scan and two cognitive testing sessions across one week
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Imaging occurred during a single session with each subject.Standardized Uptake Value Ratio on flutemetamol scan will be the imaging marker of Alzheimer's disease pathology.
Outcome measures
| Measure |
Flute
n=27 Participants
Flutemetamol PET scan.
18F-Flutemetamol: All subjects will undergo a PET scan with 18F-PIB. Approximately 185 MBq (5 mCi) of 18F-PIB will be injected intravenously and PET data collected for each subject.
|
|---|---|
|
Amyloid Deposition Obtained on a 18F-flutemetamol Brain Scan.
|
1.65 ratio of flutemetamol absorbed
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: baseline, one weekThis z-scores is based on a test of visual learning and memory, which was administered to subjects twice across one week. The amount of change that individuals show across one week is the baseline measure assessed with this variable. We focused on the amount of change observed on the Delayed Recall trial of this test between baseline and one week (i.e., practice effect). The practice effect score on this test is represented as a z-score (M = 0, SD = 1), with higher scores indicating more improvement across one week, which is better result than lower scores.
Outcome measures
| Measure |
Flute
n=27 Participants
Flutemetamol PET scan.
18F-Flutemetamol: All subjects will undergo a PET scan with 18F-PIB. Approximately 185 MBq (5 mCi) of 18F-PIB will be injected intravenously and PET data collected for each subject.
|
|---|---|
|
Change in Participant Z-score
|
-0.07 z-score
Standard Deviation 0.77
|
Adverse Events
Flute and pe
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