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Completed

NCT Number: NCT03373604

Imaging Tau in Alzheimer's Disease and Normal Aging

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.

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Key information

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 50 and older.
  • Meet criteria for either
  • amnestic mild cognitive impairment (MCI) (single or mixed domain) or mild Alzheimer's disease (AD), or
  • 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 magnetic resonance imaging (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 screening visit.
  • History of liver disease or presence of impaired liver function based on laboratory tests at 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.

Treatment and study plan

18F-MK-6240

Drug

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

Lumbar Puncture (optional)

Procedure

Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.

Primary outcomes

  1. 18F-MK-6240 Binding

    Time frame: 1 day

    Standardized uptake value ratio (SUVr)

Secondary outcomes

  1. Correlation Between Tau, Neurodegeneration and Inflammation Using PET and CSF Biomarkers.

    Time frame: One year follow-up

    Correlation of 18F-MK-6240 binding and CSF markers of neurodegeneration and inflammation.

Sponsors and collaborators

Lead sponsor

Patrick Lao

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 14, 2017
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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