University of Washington Alzheimer's Disease Research Center (UW ADRC) Imaging & Biomarker Core

October 31, 2022 updated by: Thomas Grabowski, University of Washington
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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Christina Caso
  • Phone Number: 206-221-9038
  • Email: cdcaso@uw.edu

Study Contact Backup

  • Name: Annika Noreen, PhD
  • Phone Number: 206-685-1221
  • Email: annikn@uw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

53 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals with preclinical, prodromal, or mild dementia due to Alzheimer's disease, based on amyloid biomarker evidence

Description

Inclusion Criteria:

  1. Amnestic MCI or Amnestic multimodal MCI or dementia primarily attributed to AD, by consensus diagnosis in the ADRC Clinical Core;
  2. Evidence of A+ T+ Alzheimer disease by CSF evaluation (e.g. low amyloid beta(AB)42 or 42/40 ratio and elevated p-181-tau); or evidence of A+ Alzheimer disease by amyloid PET.
  3. Age of presentation for first evaluation > 55 years;
  4. Sporadic onset, defined by not from a known autosomal dominant AD family and not more than 1 first degree relative with dementia onset before age 65;
  5. Clinical Dementia Rating scale (CDR) score 0.5 or 1.0;
  6. English competency sufficient to complete cognitive testing battery to the satisfaction of ADRC neuropsychologist;
  7. MRI scan in the Clinical Core, with additional selection for topographic diversity, based on the MRI imaging.

Exclusion Criteria:

  1. History of symptomatic cerebrovascular disease (CVD) or CVD evaluated to contribute significantly to cognitive impairments;
  2. Parkinsonism, or meeting revised McKeith criteria for possible or probable Dementia with Lewy bodies;
  3. Contraindication to MRI scanning (e.g. metal implants, severe claustrophobia);
  4. Premorbid history of neurologic disease that may contribute to cognitive impairment (e.g. multiple sclerosis, epilepsy, brain tumor);
  5. History of developmental dyslexia or other developmental disorder affecting validity of cognitive tests. These exclusion criteria minimize comorbidity;
  6. Pregnancy or breast-feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Alzheimer disease
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
Brain PET scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tau PET SUVR image
Time Frame: Day 1
Parametric [18F]MK6240 standardized uptake ratio images (SUVR) generated using an inferior cerebellar gray matter reference region.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Thomas J Grabowski, MD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

April 30, 2025

Study Completion (Anticipated)

April 30, 2025

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 15, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing 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

IPD Sharing Access Criteria

per National Alzheimer's Coordinating Center policy

per Cerveau Technologies, Inc policy

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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