Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults

Sponsor

Adam Brickman (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03706261

Collaborator

National Institute on Aging (NIA) (NIH)

150

Enrollment

Location

Arm

50.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: 18F-MK-6240 Drug: 18F-Florbetaben	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults

Actual Study Start Date :

Mar 22, 2019

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Offspring Cohort 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.	Drug: 18F-MK-6240 Administration of 5 mCi of 18F-MK-6240 for tau PET. Other Names: [18F]MK-6240 Drug: 18F-Florbetaben 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. Other Names: [18F]Florbetaben

Arm

Intervention/Treatment

Experimental: Offspring Cohort

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.

Drug: 18F-MK-6240

Administration of 5 mCi of 18F-MK-6240 for tau PET.

Other Names:

[18F]MK-6240

Drug: 18F-Florbetaben

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.

Other Names:

[18F]Florbetaben

Outcome Measures

Primary Outcome Measures

Regional SUVR value for 18F-MK-6240 [Up to 5 years]
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 [Up to 5 years]
18F-Florbetaben will be calculated to investigate the potential moderation of amyloid on the associations with tau.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.