- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04437290
University of Washington Alzheimer's Disease Research Center (UW ADRC) Imaging & Biomarker Core
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Amnestic MCI or Amnestic multimodal MCI or dementia primarily attributed to AD, by consensus diagnosis in the ADRC Clinical Core;
- 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.
- Age of presentation for first evaluation > 55 years;
- 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;
- Clinical Dementia Rating scale (CDR) score 0.5 or 1.0;
- English competency sufficient to complete cognitive testing battery to the satisfaction of ADRC neuropsychologist;
- MRI scan in the Clinical Core, with additional selection for topographic diversity, based on the MRI imaging.
Exclusion Criteria:
- History of symptomatic cerebrovascular disease (CVD) or CVD evaluated to contribute significantly to cognitive impairments;
- Parkinsonism, or meeting revised McKeith criteria for possible or probable Dementia with Lewy bodies;
- Contraindication to MRI scanning (e.g. metal implants, severe claustrophobia);
- Premorbid history of neurologic disease that may contribute to cognitive impairment (e.g. multiple sclerosis, epilepsy, brain tumor);
- History of developmental dyslexia or other developmental disorder affecting validity of cognitive tests. These exclusion criteria minimize comorbidity;
- Pregnancy or breast-feeding.
Study Plan
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
Sponsor
Investigators
- Principal Investigator: Thomas J Grabowski, MD, University of Washington
Publications and helpful links
General Publications
- Lohith TG, Bennacef I, Vandenberghe R, Vandenbulcke M, Salinas CA, Declercq R, Reynders T, Telan-Choing NF, Riffel K, Celen S, Serdons K, Bormans G, Tsai K, Walji A, Hostetler ED, Evelhoch JL, Van Laere K, Forman M, Stoch A, Sur C, Struyk A. Brain Imaging of Alzheimer Dementia Patients and Elderly Controls with 18F-MK-6240, a PET Tracer Targeting Neurofibrillary Tangles. J Nucl Med. 2019 Jan;60(1):107-114. doi: 10.2967/jnumed.118.208215. Epub 2018 Jun 7.
- Pascoal TA, Shin M, Kang MS, Chamoun M, Chartrand D, Mathotaarachchi S, Bennacef I, Therriault J, Ng KP, Hopewell R, Bouhachi R, Hsiao HH, Benedet AL, Soucy JP, Massarweh G, Gauthier S, Rosa-Neto P. In vivo quantification of neurofibrillary tangles with [18F]MK-6240. Alzheimers Res Ther. 2018 Jul 31;10(1):74. doi: 10.1186/s13195-018-0402-y.
- Koole M, Lohith TG, Valentine JL, Bennacef I, Declercq R, Reynders T, Riffel K, Celen S, Serdons K, Bormans G, Ferry-Martin S, Laroque P, Walji A, Hostetler ED, Briscoe RJ, de Hoon J, Sur C, Van Laere K, Struyk A. Preclinical Safety Evaluation and Human Dosimetry of [18F]MK-6240, a Novel PET Tracer for Imaging Neurofibrillary Tangles. Mol Imaging Biol. 2020 Feb;22(1):173-180. doi: 10.1007/s11307-019-01367-w.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00009617
- P30AG066509 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
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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