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Tau PET Imaging in the Northern Manhattan Study of Metabolism and Mind. (NOMEM-Tau)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03389100
Recruitment Status : Enrolling by invitation
First Posted : January 3, 2018
Last Update Posted : July 14, 2021
Sponsor:
Collaborators:
Hebrew Home at Riverdale
National Institute on Aging (NIA)
Information provided by (Responsible Party):
José A. Luchsinger, Columbia University

Study Description
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Brief Summary:
This is a single center brain Positron Emission Tomography (PET) study of 18F-MK-6240. Eligible participants are persons from Northern Manhattan who self-identify as Hispanic, non-Hispanic Black, or Non-Hispanic White, who are 55 to 69 years of age, of both sexes, without dementia, who have already agreed to undergo, of have undergone, brain amyloid PET and magnetic resonance imaging (MRI). Those eligible will have one brain PET scan with 18F-MK-6240, repeated after 18 months to 30 months. Vital signs will be checked prior to injection of 18F-MK-6240 and again at the completion of the PET scan. The primary objective is to relate diabetes status and glycemia to in-vivo brain tau accumulation, across and within ethnic and racial groups.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Pre-diabetes Drug: 18F-MK6240 injection Phase 2

Detailed Description:
  1. Subject recruitment and screening procedures. Subjects will be recruited from community dwelling persons from Northern Manhattan, men and women, aged 55 to 69 years, who have already undergone or agreed to undergo, brain magnetic resonance imaging (MRI) and Florbetaben positron emission tomography (PET) as part of Columbia IRB protocol AAAQ2950 (PI: Luchsinger). Recruitment of participants for these studies and all study procedures, including brain MRI, Florbetaben PET, and tau PET, are funded by existing grant from the National Institutes of Health awarded to PI Luchsinger (R01AG050440, RF1AG051556-01S2, R01AG055299)
  2. Imaging procedures related to 18F-MK-6240 PET. One brain MRI will be performed on each subject using a 3 T Philips scanner. Sequences performed will include 3D T1 (MPRAGE, 180 slice 1 mm resolution, 256 x 256 voxel count) for volumetric analysis and clinical sequences to exclude subjects with significant intracranial pathology unrelated to AD, such as malignant brain tumor of subdural hematoma. PET scans will take place on a Biograph mCT PET scanner (Siemens Healthcare) at the CUMC Kreitchman PET Center. Subjects will have one PET scan with 18F-MK-6240 (injected activity up to 5 mCi = 185 MBq). PET imaging will be performed without arterial sampling. Vital signs (blood pressure, heart rate, respiratory rate, and temperature) will be checked prior to injection of 18F-MK-6240, then at the completion of the PET scan. 18F-MK-6240 will be purchased from Cerveau Technologies, Inc. via a licensed production facility. Subjects will not be informed of 18F-MK-6240 PET scan results, as this scan is used only in research and have not yet been validated for clinical use. Subjects will be informed if a clinically important abnormality is detected on MRI or PET imaging (e.g., brain tumor).
  3. Image processing FreeSurfer (http://surfer.nmr.mgh.harvard.edu/), the MRI software package comprising a suite of automated tools for segmentation, reconstruction, and derivation of regional volumes and surface-based rendering, will be used for derivation of regions-of-interest (ROIs). Eleven ROIs will be extracted from the structural T1 image: entorhinal cortex, hippocampus, inferior temporal cortex, combined superior and middle temporal cortex, superior parietal lobule, inferior parietal lobule, precuneus, occipital cortex, prefrontal cortex, striatum, and thalamus. 18F-MK-6240 PET images will be analyzed as follows: Freesurfer based ROIs will be applied to coregistered PET images. Correction for partial volume effects using a region-based voxel-wise method92 will be applied to compare to partial volume uncorrected data. Regional time-activity curves will be extracted from the PET scans, including cerebellum which will be used as a reference region. Standardized uptake value ratio (SUVR) values will be calculated by dividing SUV values for each target region by that of the cerebellum. Alternative analytic methods such as Logan DVR and Simplified Reference Tissue Method may also be applied to compare to SUVR data.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Study subjects will receive a single injection of 18F-MK6240 for tau positron emission tomography (PET) imaging two times, separated by an interval between 18 and 30 months.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Tau Positron Emission Tomography (PET) Imaging in the Northern Manhattan Study of Metabolism and Mind (NOMEM) With 18F-MK6240.
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: 18F-MK6240 injection
intravenous injection of 18F-MK-6240, up to 5 mCi (185 MBq), IV, total of one injection per PET scan (2 injections in total with an interval of 18 to 30 months)
 Drug: 18F-MK6240 injection
Intravenous injection of 18F-MK-6240, up to 5 mCi (185 MBq), total of one injection per PET scan (2 injections in total with an interval of 18 to 30 months)
Other Name: MK6240


Outcome Measures
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Primary Outcome Measures :
  1. 18F-MK6240 standardized update value ratio (SUVR) [ Time Frame: 18 to 30 months ]
    The primary outcome measure will be regional standardized uptake value ratio (SUVR) values for 18F-MK-6240 using cerebellum as reference region. Kinetic modeling using Logan DVR method may also be employed. Multiple brain regions will be measured, with particular attention to medial temporal cortex structures such as hippocampus and entorhinal cortex


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 55 to 69 years
  2. Without dementia
  3. Fluent in English and/or Spanish.
  4. Living in Northern Manhattan.
  5. Self-identified as Hispanic, non-Hispanic Black, or non-Hispanic White.
  6. Already had or agreed to have a brain MRI and Florbetaben PET.
  7. Able to participate in all scheduled evaluations and to complete all required tests and procedures.

Exclusion Criteria:

  1. Dementia diagnosis
  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. Persons with serious chronic conditions (e.g. Liver Cirrhosis, renal failure), which, in the opinion of the investigator, could increase the risk of un-anticipated adverse events.
  4. Contraindication to MRI scanning
  5. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
  6. Inability to have a catheter in subject's vein for the injection of radioligand.
  7. Inability to have blood drawn from subject's veins.
  8. Women in the age group that we are recruiting are highly unlikely to be pre-menopausal, and thus, highly unlikely to be menstruating. However, we will ask all women if they are post-menopausal, and in the rare case that they are not, we will conduct a urine pregnancy test to rule out pregnancy.

Breastfeeding women will be excluded, although we expect this situation to be rare

Contacts and Locations
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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): NCT03389100


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Hebrew Home at Riverdale
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Jose A Luchsinger, MD Columbia University
More Information
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Publications of Results:

Other Publications:

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Responsible Party: José A. Luchsinger, Associate Professor, Columbia University
ClinicalTrials.gov Identifier: NCT03389100    
Other Study ID Numbers: AAAR1419b
R01AG050440 ( U.S. NIH Grant/Contract )
R01AG055299 ( U.S. NIH Grant/Contract )
RF1AG051556 ( U.S. NIH Grant/Contract )
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to share data with the data sharing platform of the NIA consortium named "Molecular Mechanisms of the Vascular Etiology of Alzheimer's disease (M2OVE-AD)" for data collection supported by grant RF1AG051556. This data sharing platform is called Synapse, and is managed by SAGE bionetworks. The main data from this protocol to be shared are summary values of brain Tau SUVR, demographics, and clinical variables such as diabetes status.
Supporting Materials: Study Protocol
Time Frame: Data will be released twice a year to SAGE bionetworks for sharing.
Access Criteria: Synapse operates under comprehensive governance policies. These policies delineate Synapse users' rights and responsibilities. They also specify the rights and responsibilities of Sage Bionetworks and of the Synapse Access and Compliance Team (ACT).
URL: http://docs.synapse.org/articles/governance.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José A. Luchsinger, Columbia University:
diabetes
hyperglycemia
tau
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases