Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults

Alzheimer Disease Clinical Trial

Official title:

Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03706261
• Other study ID #: AAAR8986
• Secondary ID: 1RF1AG058067-01A
• Status: Completed
• Phase: Phase 1
• Start date: March 22, 2019
• Est. completion date: July 14, 2023

Study information

• Verified date: September 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: July 14, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• 18F-MK-6240
Administration of 5 mCi of 18F-MK-6240 for tau PET.
• 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 Aß PET imaging.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Adam Brickman	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 5 years
Primary	Amyloid Positivity (Aß+) for 18F-Florbetaben	18F-Florbetaben will be calculated to investigate the potential moderation of amyloid on the associations with tau.	Up to 5 years