Imaging Tau in Alzheimer's Disease and Normal Aging

September 16, 2022 updated by: James M Noble, MD, MS, CPH, FAAN

Imaging Tau in Alzheimer's Disease and Normal Aging With 18F-MK-6240

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • [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 Names:
  • [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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
18F-MK-6240 binding
Time Frame: Up to one year from screening.
Standardized uptake value ratio (SUVr)
Up to one year from screening.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to one year from screening.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

James M Noble, MD, MS, CPH, FAAN

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: James Noble, MD, MS, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2017

Primary Completion (Actual)

May 11, 2022

Study Completion (Actual)

May 11, 2022

Study Registration Dates

First Submitted

December 11, 2017

First Submitted That Met QC Criteria

December 11, 2017

First Posted (Actual)

December 14, 2017

Study Record Updates

Last Update Posted (Actual)

September 19, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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