Alzheimer DiseasePhase 2ADRC PETNCT07758660
Alzheimer's Disease Research Center (ADRC) PET Component Study
A Phase 2 study testing 18F-MK6240 and 18F-Florbetaben (FBB) in people with Alzheimer Disease and Mild Cognitive Impairment (MCI), run by Patrick Lao at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment (MCI), Dementia
- What is being tested?
- 18F-MK6240 and 18F-Florbetaben (FBB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2026to 31 May 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Alzheimer's Disease Research Center PET Component
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).
Read the 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.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment (MCI), Dementia
- Being tested
- 18F-MK6240, 18F-Florbetaben (FBB)
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-MK6240Drug
Also called [18F-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.
18F-Florbetaben (FBB)Drug
Also called [18F] Florbetaben
Florbetaben has been approved by the FDA to help diagnose Alzheimer's disease. Florbetaben measures amyloid in the brain.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive impairment | Experimental | 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. Receives: Drug: 18F-MK6240; Drug: 18F-Florbetaben (FBB) |
| No cognitive impairment | Active comparator | Healthy elderly controls and nonpatient volunteers with subjective or objective features of normal aging. Receives: Drug: 18F-MK6240; Drug: 18F-Florbetaben (FBB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start6 Aug 2026
- Primary completion31 May 2031 (estimated)
- Study completion31 May 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patrick Lao
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Patrick Lao, Columbia University
- Investigators
- Patrick J Lao, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758660
- Sponsor's protocol ID
- ACYY0282
- Other IDs
- P30AG066462
- Acronym
- ADRC PET
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available upon reasonable request from a qualified investigator.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alzheimer's Disease Research Center PET Component
- ClinicalTrials.gov ID
- NCT07758660
- Acronym / sponsor ID
- ADRC PET / ACYY0282
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment (MCI), Dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Patrick LaoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 31 May 2033 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive impairment | Experimental | Drug: 18F-MK6240, Drug: 18F-Florbetaben (FBB)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. |
| No cognitive impairment | Active comparator | Drug: 18F-MK6240, Drug: 18F-Florbetaben (FBB)Healthy elderly controls and nonpatient volunteers with subjective or objective features of normal aging. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-MK6240Also: [18F-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. | Drug | Cognitive impairment, No cognitive impairment |
| 18F-Florbetaben (FBB)Also: [18F] FlorbetabenFlorbetaben has been approved by the FDA to help diagnose Alzheimer's disease. Florbetaben measures amyloid in the brain. | Drug | Cognitive impairment, No cognitive impairment |
Primary outcome
18F-FBB Standardized Uptake Value Ratio
Time frame: 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
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data will be available upon reasonable request from a qualified investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick J Lao, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-MK6240 and 18F-Florbetaben (FBB) in people with Alzheimer Disease and Mild Cognitive Impairment (MCI), run by Patrick Lao at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18F-FBB Standardized Uptake Value Ratio (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.