Alzheimer DiseasePhase 1NCT03706261
Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults
A Phase 1 study testing 18F-MK-6240 and 18F-Florbetaben in people with Alzheimer Disease, run by Adam Brickman at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- 18F-MK-6240 and 18F-Florbetaben
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2019to 14 Jul 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- 18F-MK-6240, 18F-Florbetaben
- Keywords
- Tau, Amyloid, MK-6240, Florbetaben, Racial/Ethnic Minority, Alzheimer's disease
- Medical subject headings
- Alzheimer Disease, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-MK-6240Drug
Also called [18F]MK-6240
Administration of 5 mCi of 18F-MK-6240 for tau PET.
18F-FlorbetabenDrug
Also called [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 Aβ PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| Offspring Cohort | Experimental | Racially/ethnically diverse subjects with or without a positive family history of Alzheimer's disease (AD) will have one PET scan with 18F-MK-6240 over a 30 to 60-minute scanning period, and one PET scan with 18F-Florbetaben over a 20-minute scanning period. Receives: Drug: 18F-MK-6240; Drug: 18F-Florbetaben |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Number of Participants With Amyloid Positivity (Aβ+) for 18F-Florbetaben
18F-Florbetaben will be calculated to investigate the potential moderation of amyloid on the associations with tau.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start22 Mar 2019
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adam Brickman
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Adam Brickman, Columbia University
- Investigators
- Adam M. Brickman, Ph.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706261
- Sponsor's protocol ID
- AAAR8986
- Other IDs
- 1RF1AG058067-01A1
- Status last verified
- Jul 2025
- First submitted
- 11 Oct 2018
- Last updated
- 1 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Analyses are planned to be on the group level. However, we may emphasize cases that are interesting on the individual level.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults
- ClinicalTrials.gov ID
- NCT03706261
- Acronym / sponsor ID
- AAAR8986
- Conditions
- Alzheimer Disease
- Keywords
- Tau, Amyloid, MK-6240, Florbetaben, Racial/Ethnic Minority, Alzheimer's disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Adam BrickmanUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Posted 1 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Offspring Cohort | Experimental | Drug: 18F-MK-6240, Drug: 18F-FlorbetabenRacially/ethnically diverse subjects with or without a positive family history of Alzheimer's disease (AD) will have one PET scan with 18F-MK-6240 over a 30 to 60-minute scanning period, and one PET scan with 18F-Florbetaben over a 20-minute scanning period. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
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-MK-6240Also: [18F]MK-6240Administration of 5 mCi of 18F-MK-6240 for tau PET. | Drug | Offspring Cohort |
| 18F-FlorbetabenAlso: [18F]FlorbetabenAdministration 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 Aβ PET imaging. | Drug | Offspring Cohort |
Primary outcome
Regional SUVR Value for 18F-MK-6240
Time frame: 1 day
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.
Number of Participants With Amyloid Positivity (Aβ+) for 18F-Florbetaben
Time frame: 1 day
18F-Florbetaben will be calculated to investigate the potential moderation of amyloid on the associations with tau.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Analyses are planned to be on the group level. However, we may emphasize cases that are interesting on the individual level.
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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. This study is not recruiting at the moment.
Adam M. Brickman, Ph.D. 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 1 study testing 18F-MK-6240 and 18F-Florbetaben in people with Alzheimer Disease, run by Adam Brickman 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 8 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: finished, as of the sponsor's last update on 1 Aug 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Regional SUVR Value for 18F-MK-6240 (time frame: 1 day). 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 1 Aug 2025.