Alzheimer Disease, Mild Cognitive Impairment (MCI), Dementia
Conditions
Brief summary
The purpose of this study is to further engage and characterize Alzheimer's Disease Research Center (ADRC) participants through additional research opportunities, particularly PET imaging. Amyloid and Tau PET imaging will be collected in 24 participants per year, for a total of 120 participants over five years. All participants will be followed longitudinally, including through potential transitions from normal aging to mild cognitive impairment (MCI) and Alzheimer's disease and related dementias (ADRD).
Detailed description
This study is a PET imaging component of the broader Alzheimer's Disease Research Center (ADRC) Clinical Core being conducted at Columbia University Irving Medical Center and is designed to further characterize ADRC participants through amyloid and tau PET imaging. The PET component supports the broader ADRC goals of maintaining a well-characterized, diverse longitudinal cohort across the spectrum of normal aging, mild cognitive impairment (MCI), and Alzheimer's disease and related dementias (ADRD), and facilitating collaborative research on cognitive aging and ADRD. Participants in this study must first be enrolled in the parent ADRC protocol. Individuals may be approached for participation in the PET component at the time of ADRC enrollment or may be contacted after enrollment to determine their interest in participating. Participants will complete up to three outpatient visits over a 12-month period. Study procedures include informed consent, Amyloid PET, and Tau PET imaging of the brain. Depending on scheduling and eligibility, informed consent and PET imaging may occur on the same day. PET imaging data collected through this study will complement the longitudinal clinical and cognitive characterization performed under the parent ADRC protocol. Because ADRC participants are followed longitudinally, PET imaging may help characterize participants across the spectrum of cognitive aging, including potential transitions from normal cognition to MCI and ADRD.
Interventions
DRUG18F-MK6240
MK-6240 is experimental but has been used in several human studies before and has been proven to accurately measure tau in the brain.
Florbetaben has been approved by the FDA to help diagnose Alzheimer's disease. Florbetaben measures amyloid in the brain.
Sponsors
Patrick Lao
National Institute on Aging (NIA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Enrolled in the Alzheimer's Disease Resource Center (ADRC) * With or without memory problems or impairment * Able to participate in all scheduled evaluations and to complete all required tests and procedures in either English or Spanish. * In the opinion of the PI, the participant must be considered likely to comply with the study protocol and to have a high probability of completing the study.
Exclusion criteria
* Conditions precluding entry into the scanners (e.g., morbid obesity, claustrophobia, etc.) * Pregnant and/or breastfeeding * In the opinion of the PI, the subject has been determined unlikely to complete all procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 18F-FBB Standardized Uptake Value Ratio | Up to 12 months | The standardized uptake value ratio is the concentration of radioactivity measured from the 18F-FBB PET scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region). |
| 18F-MK6240 Standardized Uptake Value Ratio | Up to 12 months | The standardized uptake value ratio is the concentration of radioactivity measured from the 18F-MK6240 PET scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPatrick J Lao, PhD
Columbia University
Outcome results
None listed