An observational study in Alzheimer Disease, sponsored by Tammie L. S. Benzinger, MD, PhD. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Tammie L. S. Benzinger, MD, PhD · Observational
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).
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 814 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Tammie L. S. Benzinger, MD, PhD is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
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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.
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Exclusion Criteria:
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Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: MK 6240
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 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.
Time frame: 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.
Time frame: 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
Time frame: 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 \[structuraland functional\]).
Time frame: 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.
Time frame: 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.
Time frame: 12 years from enrollment
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Data sharing details ↗ · www.dian-info.org
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Tammie L. S. Benzinger, MD, PhD