Trial Outcomes & Findings for A Preliminary Study of 18F-AV-45 in Alzheimer's Disease and Healthy Elderly Volunteers (NCT NCT01565291)
NCT ID: NCT01565291
Last Updated: 2012-05-18
Results Overview
Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the cerebellum gray matter. Total scan length was 200 min.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
32 participants
Primary outcome timeframe
50-60 min after injection
Results posted on
2012-05-18
Participant Flow
Participant milestones
| Measure |
Subjects With AD
Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination \[MMSE\] from 10 to 24)
|
Healthy Elderly Subjects
Cognitively normal with MMSE of 29 or higher; age 50 years or older
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Subjects With AD
Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination \[MMSE\] from 10 to 24)
|
Healthy Elderly Subjects
Cognitively normal with MMSE of 29 or higher; age 50 years or older
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Preliminary Study of 18F-AV-45 in Alzheimer's Disease and Healthy Elderly Volunteers
Baseline characteristics by cohort
| Measure |
Subjects With AD
n=16 Participants
Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination \[MMSE\] from 10 to 24)
|
Healthy Elderly Subjects
n=16 Participants
Cognitively normal with MMSE of 29 or higher; age 50 years or older
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
75.8 years
STANDARD_DEVIATION 9.2 • n=99 Participants
|
72.5 years
STANDARD_DEVIATION 11.56 • n=107 Participants
|
74.3 years
STANDARD_DEVIATION 10.44 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
16 participants
n=107 Participants
|
32 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 50-60 min after injectionPopulation: 4 subjects in AD group and 1 subject in the healthy elderly group were excluded due to poor placement and/or excessive movement in the scanner during the 200-minute procedure.
Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the cerebellum gray matter. Total scan length was 200 min.
Outcome measures
| Measure |
Subjects With AD
n=11 Participants
Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination \[MMSE\] from 10 to 24)
|
Healthy Elderly Subjects
n=15 Participants
Cognitively normal with MMSE of 29 or higher; age 50 years or older
|
|---|---|---|
|
Mean Cortical to Cerebellum SUVR
|
1.665 SUVR
Standard Deviation 0.175
|
1.246 SUVR
Standard Deviation 0.177
|
SECONDARY outcome
Timeframe: 50-60 min after injectionPopulation: 4 subjects in AD group and 1 subject in the healthy elderly group were excluded due to poor placement and/or excessive movement in the scanner during the 200-minute procedure.
Ratio of uptake in the precuneus to uptake in the cerebellum.
Outcome measures
| Measure |
Subjects With AD
n=11 Participants
Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination \[MMSE\] from 10 to 24)
|
Healthy Elderly Subjects
n=15 Participants
Cognitively normal with MMSE of 29 or higher; age 50 years or older
|
|---|---|---|
|
Precuneus to Cerebellum SUVR
|
1.847 SUVR
Standard Deviation 0.237
|
1.300 SUVR
Standard Deviation 0.271
|
Adverse Events
Subjects With AD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Elderly Subjects
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 |
Subjects With AD
n=16 participants at risk
Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination \[MMSE\] from 10 to 24)
|
Healthy Elderly Subjects
n=16 participants at risk
Cognitively normal with MMSE of 29 or higher; age 50 years or older
|
|---|---|---|
|
Nervous system disorders
HEADACHE
|
0.00%
0/16 • AEs occuring within 3 days of injection. SAEs occuring within 30 days of injection
|
6.2%
1/16 • Number of events 1 • AEs occuring within 3 days of injection. SAEs occuring within 30 days of injection
|
|
Psychiatric disorders
CLAUSTROPHOBIA
|
0.00%
0/16 • AEs occuring within 3 days of injection. SAEs occuring within 30 days of injection
|
6.2%
1/16 • Number of events 1 • AEs occuring within 3 days of injection. SAEs occuring within 30 days of injection
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60