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Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-MK-6240
18F-Florbetaben
Sponsored by
Adam Brickman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer Disease focused on measuring Tau, Amyloid, MK-6240, Florbetaben, Racial/Ethnic Minority, Alzheimer's disease

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 35 - 85 years
  • Have either mild cognitive impairment or mild clinical Alzheimer's disease; or have no problem with memory or thinking.
  • Able to participate in all scheduled evaluations and to complete all required tests and procedures
  • 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 a certain brain disease other than mild cognitive impairment or mild clinical Alzheimer's disease.
  • Certain significant medical conditions. Examples are uncontrolled epilepsy or multiple serious injuries.
  • Unable to lie still for PET scans.
  • Radiation exposure for research studies in the last year that would put you past allowable limits if included in this study.
  • Participation in the last year in a clinical trial for a disease modifying drug for AD unless it can be determined that your received placebo and not active drug.
  • Conditions that preclude entry into the scanner (e.g. claustrophobia, etc.).
  • Inability to have a catheter in your vein for the injection of the radioligand (dye).
  • Currently pregnant or breastfeeding.

Sites / Locations

  • Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Offspring Cohort

Arm Description

Racially/ethnically diverse subjects with or without a positive family history of Alzheimer's disease (AD) will have one PET scan with 18F-MK-6240 over a 30 to 60-minute scanning period, and one PET scan with 18F-Florbetaben over a 20-minute scanning period.

Outcomes

Primary Outcome Measures

Regional SUVR value for 18F-MK-6240
Regional standardized uptake value ratio (SUVR) for 18F-MK-6240 will be calculated to investigate associations with measures of memory, olfactory function, and cerebrovascular disease.
Amyloid Positivity (Aβ+) for 18F-Florbetaben
18F-Florbetaben will be calculated to investigate the potential moderation of amyloid on the associations with tau.

Secondary Outcome Measures

Full Information

First Posted
October 11, 2018
Last Updated
September 15, 2023
Sponsor
Adam Brickman
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03706261
Brief Title
Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults
Official Title
Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 22, 2019 (Actual)
Primary Completion Date
July 14, 2023 (Actual)
Study Completion Date
July 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adam Brickman
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
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study employs tau positron emission tomography (PET) imaging in a well-characterized multi-racial/ethnic cohort to examine the extent to which tau pathology is associated with cognition, differences in tau pathology across racial/ethnic groups, and the relationship between MRI markers of small-vessel cerebrovascular disease and tau pathology. The study also investigates amyloid-dependent tau spreading.
Detailed Description
Deposition of hyperphosphorylated tau protein is observed in several neurodegenerative diseases including Alzheimer's Disease (AD), progressive supranuclear palsy, corticobasal degeneration, chronic traumatic encephalopathy, and frontotemporal lobar degeneration. Tau is a microtubular protein and its native function is to provide structural support to neurons. Paired helical filaments composed of dysfunctional tau protein are found in several neurodegenerative diseases. In AD, the clinical progression of dementia has been shown to correlate with the amount and topographical spread of tau throughout the brain. Therefore, detecting and quantifying tau aggregate load in brain would have diagnostic and prognostic potential in clinical management of several neurological diseases. As disease modifying drugs that target tau are being developed, there is a critical need for a reliable method of detecting tau aggregates to confirm pathology in patients entering clinical trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Tau, Amyloid, MK-6240, Florbetaben, Racial/Ethnic Minority, Alzheimer's disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Offspring Cohort
Arm Type
Experimental
Arm Description
Racially/ethnically diverse subjects with or without a positive family history of Alzheimer's disease (AD) will have one PET scan with 18F-MK-6240 over a 30 to 60-minute scanning period, and one PET scan with 18F-Florbetaben over a 20-minute scanning period.
Intervention Type
Drug
Intervention Name(s)
18F-MK-6240
Other Intervention Name(s)
[18F]MK-6240
Intervention Description
Administration of 5 mCi of 18F-MK-6240 for tau PET.
Intervention Type
Drug
Intervention Name(s)
18F-Florbetaben
Other Intervention Name(s)
[18F]Florbetaben
Intervention Description
Administration of 8.1 mCi as a slow single intravenous bolus (6 sec/mL) in a total volume of up to 10 mL of 18F-Florbetaben for Aβ PET imaging.
Primary Outcome Measure Information:
Title
Regional SUVR value for 18F-MK-6240
Description
Regional standardized uptake value ratio (SUVR) for 18F-MK-6240 will be calculated to investigate associations with measures of memory, olfactory function, and cerebrovascular disease.
Time Frame
Up to 5 years
Title
Amyloid Positivity (Aβ+) for 18F-Florbetaben
Description
18F-Florbetaben will be calculated to investigate the potential moderation of amyloid on the associations with tau.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 35 - 85 years Have either mild cognitive impairment or mild clinical Alzheimer's disease; or have no problem with memory or thinking. Able to participate in all scheduled evaluations and to complete all required tests and procedures 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 a certain brain disease other than mild cognitive impairment or mild clinical Alzheimer's disease. Certain significant medical conditions. Examples are uncontrolled epilepsy or multiple serious injuries. Unable to lie still for PET scans. Radiation exposure for research studies in the last year that would put you past allowable limits if included in this study. Participation in the last year in a clinical trial for a disease modifying drug for AD unless it can be determined that your received placebo and not active drug. Conditions that preclude entry into the scanner (e.g. claustrophobia, etc.). Inability to have a catheter in your vein for the injection of the radioligand (dye). Currently pregnant or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam M. Brickman, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Analyses are planned to be on the group level. However, we may emphasize cases that are interesting on the individual level.

Learn more about this trial

Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults

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