Imaging Tau in Alzheimer's Disease and Normal Aging

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-11

Study Completion Date

2022-05-11

Brief Summary

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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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Detailed Description

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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.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cognitive impairment

Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia)

Group Type EXPERIMENTAL

18F-MK-6240

Intervention Type 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.

Lumbar Puncture (optional)

Intervention Type PROCEDURE

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

No cognitive impairment

Healthy controls

Group Type ACTIVE_COMPARATOR

18F-MK-6240

Intervention Type 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.

Lumbar Puncture (optional)

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type DRUG

Lumbar Puncture (optional)

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

Intervention Type PROCEDURE

Other Intervention Names

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[18F]-MK6240

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Patrick Lao

Assistant Professor of Neurological Sciences

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Patrick Lao, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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Klein J, Yan X, Johnson A, Tomljanovic Z, Zou J, Polly K, Honig LS, Brickman AM, Stern Y, Devanand DP, Lee S, Kreisl WC. Olfactory Impairment Is Related to Tau Pathology and Neuroinflammation in Alzheimer's Disease. J Alzheimers Dis. 2021;80(3):1051-1065. doi: 10.3233/JAD-201149.

Reference Type DERIVED

PMID: 33646153 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document