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Imaging Tau in Alzheimer's Disease and Normal Aging

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ClinicalTrials.gov Identifier: NCT02884492
Recruitment Status : Terminated (Stopped due to published data regarding THK-5351 non-specificity in Tau imaging)
First Posted : August 31, 2016
Results First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
William Charles Kreisl, Columbia University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Alzheimer's Disease
Interventions Drug: 18F-THK-5351
Procedure: Lumbar Puncture (optional)
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cognitive Impairment No Cognitive Impairment
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 7 10
Completed 7 10
Not Completed 0 0
Arm/Group Title Cognitive Impairment No Cognitive Impairment Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 7 10 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 17 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  14.3%
3
  30.0%
4
  23.5%
>=65 years
6
  85.7%
7
  70.0%
13
  76.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 17 participants
Female
2
  28.6%
7
  70.0%
9
  52.9%
Male
5
  71.4%
3
  30.0%
8
  47.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 17 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
4
  40.0%
4
  23.5%
White
7
 100.0%
6
  60.0%
13
  76.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 10 participants 17 participants
7 10 17
1.Primary Outcome
Title 18F-THK-5351 Standardized Uptake Value Ratio
Hide Description 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.
Time Frame PET image data collected 50 min post-injection to 70 min post-injection of 18F-THK-5351
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Impairment No Cognitive Impairment
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 7 10
Median (Full Range)
Unit of Measure: Standardized uptake value ratio
1.78
(1.41 to 2.04)
1.44
(1.08 to 1.56)
Time Frame Up to 24 hours after the PET scan for follow up adverse event reporting
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive Impairment No Cognitive Impairment
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Cognitive Impairment No Cognitive Impairment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive Impairment No Cognitive Impairment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cognitive Impairment No Cognitive Impairment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/10 (0.00%) 
Early termination leading to small numbers of subjects analyzed. THK-5351 has been found to bind to monoamine oxidase B as well as to tau aggregates.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: William C. Kreisl, MD
Organization: Columbia University Medical Center (Taub Institute)
Phone: 212-305-9194
Responsible Party: William Charles Kreisl, Columbia University
ClinicalTrials.gov Identifier: NCT02884492     History of Changes
Other Study ID Numbers: AAAQ7868
1K23AG052633-01 ( U.S. NIH Grant/Contract )
First Submitted: August 25, 2016
First Posted: August 31, 2016
Results First Submitted: July 28, 2018
Results First Posted: November 19, 2018
Last Update Posted: November 19, 2018