Study of Tau Imaging in Alzheimer's Disease
This study is looking at how a special imaging agent, [18F]MK-6240, can help us understand Alzheimer's disease. [18F]MK-6240 is a PET tracer (a substance that helps show things on a PET scan) that attaches to tau deposits in the brain. Tau deposits are abnormal protein clumps linked to Alzheimer's. Researchers want to see how these tau deposits change over time in people who have a genetic form of Alzheimer's. You might be able to join if you are at least 18 years old, have met the eligibility for the DIAN or DIAN EXR studies, and are either cognitively normal or have mild dementia. The study aims to understand the progression of tau deposits over 12 years. The current recruitment status is unclear.
- Study design
- This is an observational study, meaning researchers will watch and collect information without giving a specific treatment. It plans to include 200 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 years from enrollment to study the changes in tau deposits.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of Tau Imaging With the Use of [18F]MK-6240 Tracer
At a glance
Conditions
NCT04104659
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Washington University School of Medicine
St Louis, Missourino site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Tammie Benzinger, MD, PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Study the temporal dynamics of tau deposition (using [18F]MK-6240).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).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).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).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.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.12 years from enrollment
Neuropathological results will be aligned with in vivo imaging using an ex vivo MRI prior to sectioning.