Alzheimer DiseaseNCT04437290
University of Washington Alzheimer's Disease Research Center (UW ADRC) Imaging & Biomarker Core
An observational study of Alzheimer Disease, run by University of Washington.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- investigational radiotracer [18F]MK6240
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with preclinical, prodromal, or mild dementia due to Alzheimer's disease, based on amyloid biomarker evidence
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- investigational radiotracer [18F]MK6240
- Keywords
- mild cognitive impairment, dementia, tau
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
investigational radiotracer [18F]MK6240Drug
Brain PET scan
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: investigational radiotracer [18F]MK6240 |
What is being measured
The primary outcome is the main question the study is designed to answer.
tau PET SUVR image
Parametric [18F]MK6240 standardized uptake ratio images (SUVR) generated using an inferior cerebellar gray matter reference region.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study startNov 2022 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Ellison Foundation
- Responsible party
- Principal investigator, Thomas Grabowski, University of Washington
- Investigators
- Thomas J Grabowski, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437290
- Sponsor's protocol ID
- STUDY00009617
- Other IDs
- P30AG066509
- Status last verified
- Oct 2022
- First submitted
- 15 Jun 2020
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 29880509Pascoal 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.
PubMed 30064520Koole 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.
PubMed 31111397
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Washington Alzheimer's Disease Research Center (UW ADRC) Imaging & Biomarker Core
- ClinicalTrials.gov ID
- NCT04437290
- Acronym / sponsor ID
- STUDY00009617
- Conditions
- Alzheimer Disease
- Keywords
- mild cognitive impairment, dementia, tau
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Ellison Foundation
- Study start
- Nov 2022 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alzheimer disease | – | Drug: investigational radiotracer [18F]MK6240The 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 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with preclinical, prodromal, or mild dementia due to Alzheimer's disease, based on amyloid biomarker evidence
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| investigational radiotracer [18F]MK6240Brain PET scan | Drug | Alzheimer disease |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Background: PubMed 29880509Lohith 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.
- Background: PubMed 30064520Pascoal 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.
- Background: PubMed 31111397Koole 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J Grabowski, MD principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina Caso (206-221-9038, cdcaso@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tau PET SUVR image (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04437290, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.