Trial Outcomes & Findings for Imaging Tau in Alzheimer's Disease and Normal Aging (NCT NCT03373604)
NCT ID: NCT03373604
Last Updated: 2025-05-08
Results Overview
Standardized uptake value ratio (SUVr)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
1 day
Results posted on
2025-05-08
Participant Flow
Participant milestones
| Measure |
No Cognitive Impairment
Healthy participants without cognitive impairment
|
Cognitive Impairment
Participants with mild cognitive impairment or mild stage Alzheimer's disease dementia
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
28
|
|
Overall Study
COMPLETED
|
43
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imaging Tau in Alzheimer's Disease and Normal Aging
Baseline characteristics by cohort
| Measure |
No Cognitive Impairment
n=43 Participants
Healthy participants without cognitive impairment
|
Cognitive Impairment
n=28 Participants
Participants with mild cognitive impairment or mild stage Alzheimer's disease dementia
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.6 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
69.5 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
70.1 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
28 participants
n=7 Participants
|
71 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayStandardized uptake value ratio (SUVr)
Outcome measures
| Measure |
No Cognitive Impairment
n=43 Participants
Healthy participants without cognitive impairment
|
Cognitive Impairment
n=28 Participants
Participants with mild cognitive impairment or mild stage Alzheimer's disease dementia
|
|---|---|---|
|
18F-MK-6240 Binding
|
1.41 SUVr
Standard Deviation 0.43
|
2.30 SUVr
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: One year follow-upCorrelation of 18F-MK-6240 binding and CSF markers of neurodegeneration and inflammation.
Outcome measures
| Measure |
No Cognitive Impairment
n=43 Participants
Healthy participants without cognitive impairment
|
Cognitive Impairment
n=28 Participants
Participants with mild cognitive impairment or mild stage Alzheimer's disease dementia
|
|---|---|---|
|
Correlation Between Tau, Neurodegeneration and Inflammation Using PET and CSF Biomarkers.
Correlation between Tau and Neurodegeneration
|
-0.347 correlation coefficient (r)
|
0.013 correlation coefficient (r)
|
|
Correlation Between Tau, Neurodegeneration and Inflammation Using PET and CSF Biomarkers.
Correlation between Tau and Inflammation
|
-0.295 correlation coefficient (r)
|
0.181 correlation coefficient (r)
|
Adverse Events
No Cognitive Impairment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cognitive Impairment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
No Cognitive Impairment
n=43 participants at risk
Healthy participants without cognitive impairment
|
Cognitive Impairment
n=28 participants at risk
Participants with mild cognitive impairment or mild stage Alzheimer's disease dementia
|
|---|---|---|
|
Injury, poisoning and procedural complications
Sore arm from IV placement
|
0.00%
0/43 • During the scanning procedure (1 day), and at 1 year follow-up
|
3.6%
1/28 • During the scanning procedure (1 day), and at 1 year follow-up
|
|
Blood and lymphatic system disorders
Elevated blood pressure
|
2.3%
1/43 • During the scanning procedure (1 day), and at 1 year follow-up
|
3.6%
1/28 • During the scanning procedure (1 day), and at 1 year follow-up
|
|
Blood and lymphatic system disorders
hypoglycemia
|
2.3%
1/43 • During the scanning procedure (1 day), and at 1 year follow-up
|
0.00%
0/28 • During the scanning procedure (1 day), and at 1 year follow-up
|
|
General disorders
Chest pain
|
2.3%
1/43 • During the scanning procedure (1 day), and at 1 year follow-up
|
0.00%
0/28 • During the scanning procedure (1 day), and at 1 year follow-up
|
|
General disorders
lightheadedness
|
2.3%
1/43 • During the scanning procedure (1 day), and at 1 year follow-up
|
0.00%
0/28 • During the scanning procedure (1 day), and at 1 year follow-up
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.00%
0/43 • During the scanning procedure (1 day), and at 1 year follow-up
|
3.6%
1/28 • During the scanning procedure (1 day), and at 1 year follow-up
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/43 • During the scanning procedure (1 day), and at 1 year follow-up
|
3.6%
1/28 • During the scanning procedure (1 day), and at 1 year follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place