An observational study in Alzheimer Disease, sponsored by University of Washington. Status unknown. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2022-11-02.
Sponsored by University of Washington · Observational
This is a cross-sectional, observational study that characterizes research participants with Alzheimer's disease (AD) for their patterns of brain degeneration with the investigational tau positron emission tomography (PET) radiotracer [18F] MK-6240. The goal is to describe the topographic pattern of involvement of cerebral brain regions (topographic phenotyping) in early stage AD participants using tau PET in a sub-cohort of the University of Washington Alzheimer's Disease Research Center (ADRC) Clinical Cohort, and to make this phenotype information available to affiliated research studies at the University of Washington and to the general scientific community via the National Alzheimer's Coordinating Center.
Memory loss and dementia, including Alzheimer's disease (AD), are heterogeneous in terms of pattern of symptoms and brain atrophy, likely due to underlying variability in AD biological processes, as well as comorbidity (separate diseases that co-occur with AD). The correspondence between clinical findings and underlying cause is imperfect, though, and the field has benefitted tremendously from development of biomarkers that can be used for diagnosis, for estimation of the biological burden of pathology, and/or for tracking disease trajectories. For example, in the National Institute on Aging-Alzheimer's Association (NIA-AA) research framework, biomarkers of Amyloid beta, phosphorylated Tau, and Neurodegeneration (A/T/N) standardize the separation of cases with Alzheimer pathophysiology from those without it.
A sub-cohort of UW ADRC Clinical Core participants who have amyloid deposition (A+ by cerebrospinal fluid [CSF] or amyloid PET) and mild degrees of cognitive impairment will be investigated for their specific pattern of tau deposition with tau PET. Additionally, participants who are thought to be resilient to Alzheimer disease, e.g. 85 years or older and normal cognition, or A+ by CSF or amyloid PET and normal cognition, will also be investigated for their specific pattern of tau deposition with tau PET.
The ADRC Imaging and Biomarker Core will conduct and analyze these scans, and store the data in the Integrated Brain Imaging Center at the University of Washington Medical Center campus, which is directed by the PI, Dr. Grabowski. It will also use other data collected by ADRC Cores (such as neuropsychology testing) to perform other analysis, such as estimating resilience measures (i.e. the ability of the brain to function well in spite of the presence of AD).
This sub-cohort will aid in the investigation of Alzheimer's disease and related dementias (ADRD) by providing a means to better understand the relationships between the spatial patterns of tau deposition, neurodegeneration in the brain, cognitive symptoms, and resilience. It will provide a ready source of potential participants to the larger research community. By standardizing and supporting the collection imaging and CSF for research participants with Alzheimer's disease and related dementias under the ADRC, we promote research synergism and productivity across UW studies of AD and related disorders.
3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's planned enrollment of 300 is above the median of 200 across 780 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
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Individuals with preclinical, prodromal, or mild dementia due to Alzheimer's disease, based on amyloid biomarker evidence
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The group is composed of individuals with a consensus diagnosis of amnestic mild cognitive impairment (MCI) or amnestic multimodal MCI or dementia primarily attributed to Alzheimer's disease (AD), as determined by the UW ADRC Clinical Core. They will have age of presentation \> 55 years, sporadic onset, CDR (Clinical Dementia Rating Scale) score 0.5-1.0, and sufficient English competency to complete a standardized cognitive testing battery. All will have no contraindication to MRI and will have had an MRI scan in the UW ADRC Imaging and Biomarker Core. These participants will undergo PET scanning with the investigational tau tracer \[18F\] MK6240
Drug: investigational radiotracer [18F]MK6240
Brain PET scan
tau PET SUVR image
Parametric \[18F\]MK6240 standardized uptake ratio images (SUVR) generated using an inferior cerebellar gray matter reference region.
Time frame: Day 1
No study locations are listed for this record.
Plan to share: Yes — De-identified tau PET scans will be shared with the National Alzheimer's Coordinating Center (NACC) through the Standardized and Centralized Alzheimer's Neuroimaging initiative (U24), which will make these data available under a data use agreement to non-commercial entities and non- commercial research projects. De-identified tau PET scans will be shared with Cerveau Technologies, Inc, for their own Imaging Core database of tau PET scans internationally, under terms of our Master Research Agreement. Non-identifying information about the participants, e.g. age, sex, apolipoprotein E (APOE) genotype, research diagnosis, is also to be included in the Cerveau imaging core database.
Supporting information: Study protocol, Clinical study report
Time frame: tau PET imaging data will be uploaded to NACC within 6 months of data acquisition. tau PET imaging data will be uploaded to Cerveau Technologies, Inc within 6 months of data acquisition
Access criteria: per National Alzheimer's Coordinating Center policy per Cerveau Technologies, Inc policy
Data sharing details ↗ · www.alz.washington.edu
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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