A Phase 2 interventional study of 18F-MK6240 and 18F-Florbetaben (FBB) in Alzheimer Disease, Mild Cognitive Impairment (MCI) and Dementia, sponsored by Patrick Lao. Enrolling by invitation at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Patrick Lao · Phase 2, Interventional, and Diagnostic
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).
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Patrick Lao is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Participants with Alzheimer's disease and related disorders, including but not limited to: Frontotemporal dementia, Lewy Body dementia, Creutzfeldt-Jakob disease, other dementias, and subjective or objective features of mild cognitive change.
Drug: 18F-MK6240 · Drug: 18F-Florbetaben (FBB)
Healthy elderly controls and nonpatient volunteers with subjective or objective features of normal aging.
Drug: 18F-MK6240 · Drug: 18F-Florbetaben (FBB)
MK-6240 is experimental but has been used in several human studies before and has been proven to accurately measure tau in the brain.
Also known as: [18F-MK6240]
Florbetaben has been approved by the FDA to help diagnose Alzheimer's disease. Florbetaben measures amyloid in the brain.
Also known as: [18F] Florbetaben
18F-FBB Standardized Uptake Value Ratio
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).
Time frame: Up to 12 months
18F-MK6240 Standardized Uptake Value Ratio
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).
Time frame: Up to 12 months
Plan to share: Yes — Individual participant data will be available upon reasonable request from a qualified investigator.
Time frame: Up to two weeks after review and approval of the request.
Access criteria: Investigator qualifications and previous work will be reviewed by the PI. Subsequent email correspondence will relay the technical criteria needed for access.
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Patrick Lao