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Imaging Tau in Alzheimer's Disease and Normal Aging

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

18F-MK-6240

Lumbar Puncture (optional)

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring 18F-MK-6240, Cognitive Impairment, Alzheimer's

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 50 and older.
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.
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.

Sites / Locations

Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive impairment

No cognitive impairment

Arm Description

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

Healthy controls

Outcomes

Primary Outcome Measures

18F-MK-6240 binding

Standardized uptake value ratio (SUVr)

Secondary Outcome Measures

Correlation between tau, neurodegeneration and inflammation using PET and CSF biomarkers.

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

Full Information

NCT ID

NCT03373604

First Posted

December 11, 2017

Last Updated

September 16, 2022

Sponsor

James M Noble, MD, MS, CPH, FAAN

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT03373604

Brief Title

Imaging Tau in Alzheimer's Disease and Normal Aging

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

December 11, 2017 (Actual)

Primary Completion Date

May 11, 2022 (Actual)

Study Completion Date

May 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

James M Noble, MD, MS, CPH, FAAN

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

18F-MK-6240, Cognitive Impairment, Alzheimer's

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive impairment

Arm Type

Experimental

Arm Description

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

Arm Title

No cognitive impairment

Arm Type

Active Comparator

Arm Description

Healthy controls

Intervention Type

Drug

Intervention Name(s)

18F-MK-6240

Other Intervention Name(s)

[18F]-MK6240

Intervention Description

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

Procedure

Intervention Name(s)

Lumbar Puncture (optional)

Intervention Description

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

Primary Outcome Measure Information:

Title

18F-MK-6240 binding

Description

Standardized uptake value ratio (SUVr)

Time Frame

Up to one year from screening.

Secondary Outcome Measure Information:

Title

Correlation between tau, neurodegeneration and inflammation using PET and CSF biomarkers.

Description

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

Time Frame

Up to one year from screening.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Noble, MD, MS

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33646153

Citation

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.

Results Reference

derived

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Imaging Tau in Alzheimer's Disease and Normal Aging

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