Alzheimer DiseaseMKADADNCT04104659
Study of Tau Imaging With the Use of [18F]MK-6240 Tracer
An observational study of Alzheimer Disease, run by Tammie L. S. Benzinger, MD, PhD at 1 site in United States.
Trial summary
The recent development of a PET tracer,[18F]MK-6240(an[18F]tau imaging agent,CerveauTechnologies)that has high affinity for the human phosphorylated tau deposits in AD brain offers new opportunities to investigate tau pathology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- MK 6240
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 1 Jun 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants have met all eligibility criteria for enrollment into the Dominantly Inherited Alzheimer's Network (DIAN) and DIAN Extended Registry (DIAN EXR) study enrollment criteria.
Who may be able to join
- Participants have met all eligibility criteria for enrollment into the Dominantly Inherited Alzheimer's Network (DIAN) and DIAN Extended Registry (DIAN EXR) study enrollment criteria.
- Male or female participants, at least 18 years of age.
- Cognitively normal, or with mild dementia, as assessed clinically.
- Participant is able and willing to undergo testing (magnetic resonance imaging (MRI)or computed tomography (CT), PET, radioactive tracer injection; forthose unable to undergo MRI, CT will be used to generate regions-of interest).
- Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration. -
Who cannot join
- Has any condition that, in the Investigator's opinion, couldincrease risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severechronic back pain might not be able to lie still duringthe scanning procedures).
- Is deemed likely unable to perform the imaging procedures for any reason.
- Has hypersensitivity to [18F]MK-6240or any of its excipients.
- Contraindications to PET, PET-CT or MR(e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
- Severe claustrophobia.
- Women who are currently pregnant or breast-feeding, and women who do not agree to use reliable contraception, or to refrain from sexual activity for 24 hours following administration of the [18F]MK-6240injection will be excluded from the study.
- Currently participating in any research studyreceiving an active study medication for AD, an investigational drug, device, imaging, or placebo within the past 30 days before screening, and throughout this clinical trial up to 2-weeks past any study-related procedures.
- Other than the DIAN study, current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the US Code of Federal Regulations (CFR) Title 21 Section 631.1. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1. It is the responsibility of each site to confirm the date of the most recent PET scan and to work within the guidelines of the local Radioactive Drug Research Committee (RDRC) regarding the imaging interval. -
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
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Multicenter Study of Tau Imaging With the Use of [18F]MK-6240 Tracer in Individuals at Risk for and With Autosomal Dominant Alzheimer's Disease
The recent development of a PET tracer,[18F]MK-6240(an[18F]tau imaging agent,CerveauTechnologies)that has high affinity for the human phosphorylated tau deposits in AD brain offers new opportunities to investigate tau pathology. The investigators will evaluate this imaging agent in individuals from families with a known Autosomal Dominant Alzheimer's Disease (ADAD) mutation. This study of tau PET using [18F]MK-6240 is performed in conjunction with DIAN and DIAN Extended Registry (DIAN-EXR).
- Conditions
- Alzheimer Disease
- Being tested
- MK 6240
- Keywords
- tau, PET, MK 6240, ADAD
- 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.
MK 6240Drug
PET tracer, [18F]MK-6240 (an[18F]tau imaging agent,CerveauTechnologies)that has high affinity for the human phosphorylated tau deposits in AD brain offers new opportunities to investigate tau pathology.(Hostetler, Walji et al. 2016, Lohith, Bennacef et al. 2016, Walji, Hostetler et al. 2016, Lohith, Bennacef et al. 2017, Neelamegam, Yokell et al. 2017).We will evaluate this imaging agent in individuals from families with a known Autosomal Dominant Alzheimer's Disease (ADAD) mutation.
The planned dosage for [18F]MK-6240 is a single intravenous bolus injection of 185 MBq (5.0 mCi) in a large peripheral vein followed by a 10 mL normal saline (0.9% NaCl) flush.
| Study group | Role | What they receive |
|---|---|---|
| MK 6240 | Not described Receives: Drug: MK 6240 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the temporal dynamics of tau deposition (using [18F]MK-6240).
Aim 3 multivariate linear regression models will be implemented within the general linear mixed model framework and estimated using restricted maximum likelihood estimation. This approach allows for the estimation of the association between [18F]MK-6240 and tauopathy measures across all brain regions to be studied in a single model, by considering the dependency in the plaque measures caused by multiple brain regions being nested within a single patient.
Measured: 12 years from enrollment
Study the temporal dynamics of tau deposition (using [18F]MK-6240).
We will first fit a model in training samples and then use the fitted model to predict the longitudinal changes in tau PET and compare the predicted changes with observed data in independent validation samples. This process will be repeated multiple times, thus correcting for the upward bias and computing "honest" measures of replicability of a specific statistical model. We will repeat the cross-validation process for all scientifically interpretable candidate models that we will consider when comparing to tau PET data. A pseudo-panel from additional cross-sectional datasets can also be used in which observations of different subjects in different time-to-onset lengths are matched across observable covariates.
Measured: 12 years from enrollment
Study the temporal dynamics of tau deposition (using [18F]MK-6240).
A statistical approach will be applied but will consider both Aβ and tau PET. Neuropsychometric measures will be grouped into composites representing working memory, episodic memory, language function, and a global composite. Linear mixed effects models will be implemented including family and DIAN site as random effects. Models will include baseline levels of Aβ PET and tau PET from summary measures, EYO, group (asymptomatic and symptomatic), and all interactions
Measured: 12 years from enrollment
Study the spatial (both local and distributed) changes of tau deposition (using [18F]MK-6240).
Using novel mathematical models, we will correlate the topography of tau PET with both cross-sectional and longitudinal spatial patterns seen with other imaging biomarkers (Aβ PET and MRI [structuraland functional]).
Measured: 12 years from enrollment
Study the relationship between in vivo tau deposition and neuropathology.
We will perform quantitative measures of cortical tauopathy NFT, NP, and neuropil thread (NT) burden in twenty-five brain areas using tau-immunostained sections and automated stereological methods.
Measured: 12 years from enrollment
Study the relationship between in vivo tau deposition and neuropathology.
Neuropathological results will be aligned with in vivo imaging using an ex vivo MRI prior to sectioning.
Measured: 12 years from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Mar 2021
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jun 2027 (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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tammie L. S. Benzinger, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tammie L. S. Benzinger, MD, PhD, Washington University School of Medicine
- Investigators
- Tammie Benzinger, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104659
- Sponsor's protocol ID
- IRB #201901045
- Acronym
- MKADAD
- Status last verified
- Jun 2026
- First submitted
- 17 Apr 2019
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data will be maintained at Washington University. This de-identified data may also be shared with other investigators doing research in similar fields such as Alzheimer disease, other neurological disorders or related brain diseases andabnormalities. These investigators may be at Washington University or at other research institutions. This de-identified data may also be shared with large repositories for broad sharing with the research community. If the participant's research data is placed in one of these repositories, only qualified researchers who have received prior approval from individuals that monitor the use of the datawill be able to look at this information. Information from this research study has been or will be entered into a clinical trial databank that is maintained by the National Institutes of Health/National Library of Medicine.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Tau Imaging With the Use of [18F]MK-6240 Tracer in Individuals at Risk for and With Autosomal Dominant Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04104659
- Acronym / sponsor ID
- MKADAD / IRB #201901045
- Conditions
- Alzheimer Disease
- Keywords
- tau, PET, MK 6240, ADAD
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tammie L. S. Benzinger, MD, PhDUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 26 Sep 2019 (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 recent development of a PET tracer,[18F]MK-6240(an[18F]tau imaging agent,CerveauTechnologies)that has high affinity for the human phosphorylated tau deposits in AD brain offers new opportunities to investigate tau pathology. The investigators will evaluate this imaging agent in individuals from families with a known Autosomal Dominant Alzheimer's Disease (ADAD) mutation. This study of tau PET using [18F]MK-6240 is performed in conjunction with DIAN and DIAN Extended Registry (DIAN-EXR).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MK 6240 | – | Drug: MK 6240 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants have met all eligibility criteria for enrollment into the Dominantly Inherited Alzheimer's Network (DIAN) and DIAN Extended Registry (DIAN EXR) study enrollment criteria.
Key inclusion criteria (5 listed)
- Participants have met all eligibility criteria for enrollment into the Dominantly Inherited Alzheimer's Network (DIAN) and DIAN Extended Registry (DIAN EXR) study enrollment criteria.
- Male or female participants, at least 18 years of age.
- Cognitively normal, or with mild dementia, as assessed clinically.
- Participant is able and willing to undergo testing (magnetic resonance imaging (MRI)or computed tomography (CT), PET, radioactive tracer injection; forthose unable to undergo MRI, CT will be used to generate regions-of interest).
- Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration. -
Key exclusion criteria (8 listed)
- Has any condition that, in the Investigator's opinion, couldincrease risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severechronic back pain might not be able to lie still duringthe scanning procedures).
- Is deemed likely unable to perform the imaging procedures for any reason.
- Has hypersensitivity to [18F]MK-6240or any of its excipients.
- Contraindications to PET, PET-CT or MR(e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
- Severe claustrophobia.
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 |
|---|---|---|
| MK 6240PET tracer, [18F]MK-6240 (an[18F]tau imaging agent,CerveauTechnologies)that has high affinity for the human phosphorylated tau deposits in AD brain offers new opportunities to investigate tau pathology.(Hostetler, Walji et al. 2016, Lohith, Bennacef et al. 2016, Walji, Hostetler et al. 2016, Lohith, Bennacef et al. 2017, Neelamegam, Yokell et al. 2017).We will evaluate this imaging agent in individuals from families with a known Autosomal Dominant Alzheimer's Disease (ADAD) mutation. The planned dosage for [18F]MK-6240 is a single intravenous bolus injection of 185 MBq (5.0 mCi) in a large peripheral vein followed by a 10 mL normal saline (0.9% NaCl) flush. | Drug | MK 6240 |
Primary outcome
Study the temporal dynamics of tau deposition (using [18F]MK-6240).
Time frame: 12 years from enrollment
Aim 3 multivariate linear regression models will be implemented within the general linear mixed model framework and estimated using restricted maximum likelihood estimation. This approach allows for the estimation of the association between [18F]MK-6240 and tauopathy measures across all brain regions to be studied in a single model, by considering the dependency in the plaque measures caused by multiple brain regions being nested within a single patient.
Study the temporal dynamics of tau deposition (using [18F]MK-6240).
Time frame: 12 years from enrollment
We will first fit a model in training samples and then use the fitted model to predict the longitudinal changes in tau PET and compare the predicted changes with observed data in independent validation samples. This process will be repeated multiple times, thus correcting for the upward bias and computing "honest" measures of replicability of a specific statistical model. We will repeat the cross-validation process for all scientifically interpretable candidate models that we will consider when comparing to tau PET data. A pseudo-panel from additional cross-sectional datasets can also be used in which observations of different subjects in different time-to-onset lengths are matched across observable covariates.
Study the temporal dynamics of tau deposition (using [18F]MK-6240).
Time frame: 12 years from enrollment
A statistical approach will be applied but will consider both Aβ and tau PET. Neuropsychometric measures will be grouped into composites representing working memory, episodic memory, language function, and a global composite. Linear mixed effects models will be implemented including family and DIAN site as random effects. Models will include baseline levels of Aβ PET and tau PET from summary measures, EYO, group (asymptomatic and symptomatic), and all interactions
Study the spatial (both local and distributed) changes of tau deposition (using [18F]MK-6240).
Time frame: 12 years from enrollment
Using novel mathematical models, we will correlate the topography of tau PET with both cross-sectional and longitudinal spatial patterns seen with other imaging biomarkers (Aβ PET and MRI [structuraland functional]).
Study the relationship between in vivo tau deposition and neuropathology.
Time frame: 12 years from enrollment
We will perform quantitative measures of cortical tauopathy NFT, NP, and neuropil thread (NT) burden in twenty-five brain areas using tau-immunostained sections and automated stereological methods.
Study the relationship between in vivo tau deposition and neuropathology.
Time frame: 12 years from enrollment
Neuropathological results will be aligned with in vivo imaging using an ex vivo MRI prior to sectioning.
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 8 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified study data will be maintained at Washington University. This de-identified data may also be shared with other investigators doing research in similar fields such as Alzheimer disease, other neurological disorders or related brain diseases andabnormalities. These investigators may be at Washington University or at other research institutions. This de-identified data may also be shared with large repositories for broad sharing with the research community. If the participant's research data is placed in one of these repositories, only qualified researchers who have received prior approval from individuals that monitor the use of the datawill be able to look at this information. Information from this research study has been or will be entered into a clinical trial databank that is maintained by the National Institutes of Health/National Library of Medicine.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
Tammie Benzinger, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Tammie L. S. Benzinger, MD, PhD 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 5 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: enrolling by invitation, as of the sponsor's last update on 8 Jun 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.
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?
Study the temporal dynamics of tau deposition (using [18F]MK-6240). (time frame: 12 years from enrollment). The study lists 6 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 8 Jun 2026.