Clinical trial NCT03706261: Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults
Official title: Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Keywords: Tau
Amyloid
MK-6240
Florbetaben
Racial/Ethnic Minority
Alzheimer's disease
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-10-15
Enrollment: 145
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Regional SUVR value for 18F-MK-6240
timeFrame: Up to 5 years
measure: Amyloid Positivity (Aβ+) for 18F-Florbetaben
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Adam M. Brickman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: