Back to resultsImaging Tau in Alzheimer's Disease and Normal Aging
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
18F-THK-5351
Lumbar Puncture (optional)
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring inflammation, aging, mild cognitive impairment
Eligibility Criteria
Inclusion Criteria:
- Age 50 and older.
- Meet criteria for either a) amnestic mild cognitive impairment (single or mixed domain) or mild Alzheimer's disease, or b) have no cognitive impairment, based on history, exam, neuropsychological testing, and consensus diagnosis. MCI and mild AD patients must have Clinical Dementia Rating scale score of 0.5 or 1. Unimpaired subjects must have Clinical Dementia Rating scale score of 0.
- Subjects unable to provide informed consent must have a surrogate decision maker.
- Written and oral fluency in English or Spanish.
- Able to participate in all scheduled evaluations and to complete all required tests and procedures.
- In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.
Exclusion Criteria:
- Past or present history of certain brain disorders other than MCI or AD.
- Certain significant medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries.
- Contraindication to MRI scanning.
- Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
- History of kidney disease or presence of impaired kidney function based on laboratory tests at the screening visit.
- History of liver disease or presence of impaired liver function based on laboratory tests at the screening visit.
- Participation in the last year in a clinical trial for a disease-modifying drug for AD.
- Inability to have a catheter in subject's vein for the injection of radioligand.
- Inability to have blood drawn from subject's veins.
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive impairment
No cognitive impairment
Arm 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).
Normal aging adults will receive 18F-THK- 5351 and/or lumbar puncture (optional).
Outcomes
Primary Outcome Measures
18F-THK-5351 Standardized Uptake Value Ratio
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02884492
First Posted
August 25, 2016
Last Updated
November 14, 2018
Sponsor
William Charles Kreisl
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT02884492
Brief Title
Imaging Tau in Alzheimer's Disease and Normal Aging
Official Title
Imaging Tau in Alzheimer's Disease and Normal Aging
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Stopped due to published data regarding THK-5351 non-specificity in Tau imaging
Study Start Date
July 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
William Charles Kreisl
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being done to learn about tau tangles in Alzheimer's disease. A type of PET scan is used to measure the abnormal accumulation of protein called tau in the brain. These are thought to be involved in Alzheimer's disease. The investigators will also perform brain MRI and to tests to measure the participant's memory and thinking.
Detailed Description
This study is being done to determine the relationship between tau tangles and cognitive impairment in elderly subjects with different clinical and biomarker profiles of Alzheimer's disease (AD). Subjects will undergo screen that includes neuropsychological testing and brain MRI. This study uses a special type of scan called a PET scan to take pictures of the brain. During the PET scan, a special radioactive dye called 18F-THK-5351 is injected into the body. 18F-THK-5351 sticks to abnormal tangles made of the protein tau. Subjects will have the option to have lumbar puncture performed to measure CSF concentrations of biomarkers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
inflammation, aging, mild cognitive impairment
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive impairment
Arm Type
Experimental
Arm 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).
Arm Title
No cognitive impairment
Arm Type
Active Comparator
Arm Description
Normal aging adults will receive 18F-THK- 5351 and/or lumbar puncture (optional).
Intervention Type
Drug
Intervention Name(s)
18F-THK-5351
Other Intervention Name(s)
[18F] THK5351
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lumbar Puncture (optional)
Intervention Description
Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.
Primary Outcome Measure Information:
Title
18F-THK-5351 Standardized Uptake Value Ratio
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 50 and older.
Meet criteria for either a) amnestic mild cognitive impairment (single or mixed domain) or mild Alzheimer's disease, or b) have no cognitive impairment, based on history, exam, neuropsychological testing, and consensus diagnosis. MCI and mild AD patients must have Clinical Dementia Rating scale score of 0.5 or 1. Unimpaired subjects must have Clinical Dementia Rating scale score of 0.
Subjects unable to provide informed consent must have a surrogate decision maker.
Written and oral fluency in English or Spanish.
Able to participate in all scheduled evaluations and to complete all required tests and procedures.
In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.
Exclusion Criteria:
Past or present history of certain brain disorders other than MCI or AD.
Certain significant medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries.
Contraindication to MRI scanning.
Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
History of kidney disease or presence of impaired kidney function based on laboratory tests at the screening visit.
History of liver disease or presence of impaired liver function based on laboratory tests at the screening visit.
Participation in the last year in a clinical trial for a disease-modifying drug for AD.
Inability to have a catheter in subject's vein for the injection of radioligand.
Inability to have blood drawn from subject's veins.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William C Kreisl, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Imaging Tau in Alzheimer's Disease and Normal Aging
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