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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 Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: 18F-THK-5351 Procedure: Lumbar Puncture (optional) Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging Tau in Alzheimer's Disease and Normal Aging
Actual Study Start Date : July 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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).
 Drug: 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.
Other Name: [18F] THK5351

Procedure: Lumbar Puncture (optional)
Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.
Active Comparator: No cognitive impairment
Normal aging adults will receive 18F-THK- 5351 and/or lumbar puncture (optional).
 Drug: 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.
Other Name: [18F] THK5351

Procedure: Lumbar Puncture (optional)
Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.


Outcome Measures
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Primary Outcome Measures :
  1. 18F-THK-5351 Standardized Uptake Value Ratio [ Time Frame: PET image data collected 50 min post-injection to 70 min post-injection of 18F-THK-5351 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 50 and older.
  2. 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.
  3. Subjects unable to provide informed consent must have a surrogate decision maker.
  4. Written and oral fluency in English or Spanish.
  5. Able to participate in all scheduled evaluations and to complete all required tests and procedures.
  6. 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:

  1. Past or present history of certain brain disorders other than MCI or AD.
  2. Certain significant medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries.
  3. Contraindication to MRI scanning.
  4. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
  5. History of kidney disease or presence of impaired kidney function based on laboratory tests at the screening visit.
  6. History of liver disease or presence of impaired liver function based on laboratory tests at the screening visit.
  7. Participation in the last year in a clinical trial for a disease-modifying drug for AD.
  8. Inability to have a catheter in subject's vein for the injection of radioligand.
  9. Inability to have blood drawn from subject's veins.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884492


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
William Charles Kreisl
National Institute on Aging (NIA)
Investigators
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Principal Investigator: William C Kreisl, MD Columbia University
  Study Documents (Full-Text)

Documents provided by William Charles Kreisl, Columbia University:
Study Protocol and Statistical Analysis Plan  [PDF] May 11, 2016

More Information
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Responsible Party: William Charles Kreisl, Principal Investigator, Columbia University
ClinicalTrials.gov Identifier: NCT02884492    
Other Study ID Numbers: AAAQ7868
1K23AG052633-01 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2016    Key Record Dates
Results First Posted: November 19, 2018
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by William Charles Kreisl, Columbia University:
inflammation
aging
mild cognitive impairment
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders