Trial Outcomes & Findings for Imaging Tau in Alzheimer's Disease and Normal Aging (NCT NCT02884492)
NCT ID: NCT02884492
Last Updated: 2018-11-19
Results Overview
The standardize uptake value ratio is the concentration of radioactivity measured from the 18F-THK-5351 PET scan in the posterior cingulate gyrus, divided by that in the cerebellar gray matter (the reference region, which is expected to be devoid of tau pathology). This ratio is a relative measure of 18F-THK-5351 binding, and therefore of tau pathology, in brain tissue. PET image data was acquired from 50 min post-injection to 70 min post-injection of 18F-THK-5351.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
PET image data collected 50 min post-injection to 70 min post-injection of 18F-THK-5351
Results posted on
2018-11-19
Participant Flow
Participant milestones
| Measure |
Cognitive Impairment
Adults with Alzheimer's disease, preclinical Alzheimer's disease or impairment due to suspected non-Alzheimer's disease pathophysiology will receive 18F-THK- 5351 and/or lumbar puncture (optional).
18F-THK-5351: 18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.
Lumbar Puncture (optional): Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.
|
No Cognitive Impairment
Normal aging adults will receive 18F-THK- 5351 and/or lumbar puncture (optional).
18F-THK-5351: 18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.
Lumbar Puncture (optional): Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
|
Overall Study
COMPLETED
|
7
|
10
|
|
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 |
Cognitive Impairment
n=7 Participants
Adults with Alzheimer's disease, preclinical Alzheimer's disease or impairment due to suspected non-Alzheimer's disease pathophysiology will receive 18F-THK- 5351 and/or lumbar puncture (optional).
18F-THK-5351: 18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.
Lumbar Puncture (optional): Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.
|
No Cognitive Impairment
n=10 Participants
Normal aging adults will receive 18F-THK- 5351 and/or lumbar puncture (optional).
18F-THK-5351: 18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.
Lumbar Puncture (optional): Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 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
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 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
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: PET image data collected 50 min post-injection to 70 min post-injection of 18F-THK-5351The standardize uptake value ratio is the concentration of radioactivity measured from the 18F-THK-5351 PET scan in the posterior cingulate gyrus, divided by that in the cerebellar gray matter (the reference region, which is expected to be devoid of tau pathology). This ratio is a relative measure of 18F-THK-5351 binding, and therefore of tau pathology, in brain tissue. PET image data was acquired from 50 min post-injection to 70 min post-injection of 18F-THK-5351.
Outcome measures
| Measure |
Cognitive Impairment
n=7 Participants
Adults with Alzheimer's disease, preclinical Alzheimer's disease or impairment due to suspected non-Alzheimer's disease pathophysiology will receive 18F-THK- 5351 and/or lumbar puncture (optional).
18F-THK-5351: 18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.
Lumbar Puncture (optional): Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.
|
No Cognitive Impairment
n=10 Participants
Normal aging adults will receive 18F-THK- 5351 and/or lumbar puncture (optional).
18F-THK-5351: 18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.
Lumbar Puncture (optional): Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.
|
|---|---|---|
|
18F-THK-5351 Standardized Uptake Value Ratio
|
1.78 Standardized uptake value ratio
Interval 1.41 to 2.04
|
1.44 Standardized uptake value ratio
Interval 1.08 to 1.56
|
Adverse Events
Cognitive Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Cognitive Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
William C. Kreisl, MD
Columbia University Medical Center (Taub Institute)
Phone: 212-305-9194
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place