Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Imaging Tau in Alzheimer's Disease and Normal Aging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03373604
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : August 11, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
William Charles Kreisl, Columbia University

Brief Summary:
This study is being done to learn about tau tangles in Alzheimer's disease. A type of positron emission tomography (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 Disease Drug: 18F-MK-6240 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 and without 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-MK-6240 is injected into the body. 18F-MK-6240 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 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 With 18F-MK-6240
Actual Study Start Date : December 11, 2017
Estimated Primary Completion Date : August 20, 2022
Estimated Study Completion Date : August 20, 2022


Arm Intervention/treatment
Experimental: Cognitive impairment
Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia)
Drug: 18F-MK-6240
18F-MK-6240 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]-MK6240

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
Healthy controls
Drug: 18F-MK-6240
18F-MK-6240 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]-MK6240

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




Primary Outcome Measures :
  1. 18F-MK-6240 binding [ Time Frame: Up to one year from screening. ]
    Standardized uptake value ratio (SUVr)


Secondary Outcome Measures :
  1. Correlation between tau, neurodegeneration and inflammation using PET and CSF biomarkers. [ Time Frame: Up to one year from screening. ]
    Correlation of 18F-MK-6240 binding and CSF markers of neurodegeneration and inflammation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 100 Years   (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

    1. amnestic mild cognitive impairment (MCI) (single or mixed domain) or mild Alzheimer's disease (AD), or
    2. 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 magnetic resonance imaging (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 screening visit.
  6. History of liver disease or presence of impaired liver function based on laboratory tests at 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.

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): NCT03373604


Contacts
Layout table for location contacts
Contact: William C Kreisl, MD 212-305-9079 wck2107@cumc.columbia.edu
Contact: Aubrey Johnson 212-305-9079 aj2842@cumc.columbia.edu

Locations
Layout table for location information
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: William C Kreisl, MD    212-305-9079    wck2107@cumc.columbia.edu   
Contact: Aubrey Johnson    212-305-9079    aj2842@cumc.columbia.edu   
Principal Investigator: William C Kreisl, MD         
Sponsors and Collaborators
William Charles Kreisl
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: William Kreisl, MD Columbia University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: William Charles Kreisl, Assistant Professor of Neurology, Columbia University
ClinicalTrials.gov Identifier: NCT03373604    
Other Study ID Numbers: AAAR4352
K23AG052633-02 ( U.S. NIH Grant/Contract )
2R56AG034189-06A1 ( U.S. NIH Grant/Contract )
K24AG045334 ( U.S. NIH Grant/Contract )
R01AG055299 ( U.S. NIH Grant/Contract )
R01AG050440-02S1 ( U.S. NIH Grant/Contract )
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021

Layout table for additional information
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:
18F-MK-6240
Cognitive Impairment
Alzheimer's
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders