Study of Tau Imaging With the Use of [18F]MK-6240 Tracer (NCT04104659) | Clinical Trial Compass
By InvitationNot Applicable
Study of Tau Imaging With the Use of [18F]MK-6240 Tracer
United States200 participantsStarted 2021-03-01
Plain-language summary
The recent development of a PET tracer,\[18F\]MK-6240(an\[18F\]tau imaging agent,CerveauTechnologies)that has high affinity for the human phosphorylated tau deposits in AD brain offers new opportunities to investigate tau pathology. The investigators will evaluate this imaging agent in individuals from families with a known Autosomal Dominant Alzheimer's Disease (ADAD) mutation. This study of tau PET using \[18F\]MK-6240 is performed in conjunction with DIAN and DIAN Extended Registry (DIAN-EXR).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants have met all eligibility criteria for enrollment into the Dominantly Inherited Alzheimer's Network (DIAN) and DIAN Extended Registry (DIAN EXR) study enrollment criteria.
. Male or female participants, at least 18 years of age.
. Cognitively normal, or with mild dementia, as assessed clinically.
. Participant is able and willing to undergo testing (magnetic resonance imaging (MRI)or computed tomography (CT), PET, radioactive tracer injection; forthose unable to undergo MRI, CT will be used to generate regions-of interest).
. Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration. -
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is listed as 'enrolling by invitation only' — can you tell me whether I or my family member might be eligible to be invited, and what criteria are typically used to select participants?
2Since this trial involves a specialized PET scan using a radioactive tracer called [18F]MK-6240, can you explain what getting that injection and scan actually involves, including how much radiation exposure is typical and whether there are any known risks with this specific tracer?
3The study is tracking how tau protein deposits change over time and across different brain regions — does that mean participants would need to come back for multiple scans over months or years, and how would that fit into our schedule?
4This appears to be a research-only imaging study rather than a treatment trial — so is there any direct medical benefit to me from participating, or is the main value in contributing to Alzheimer's research for future patients?
5Given that this study is looking at the relationship between tau seen on the scan and actual brain pathology, would the results of my scan be shared with me or my care team, and could they change any treatment decisions we're already considering?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Study the temporal dynamics of tau deposition (using [18F]MK-6240).
Timeframe: 12 years from enrollment
2
Study the temporal dynamics of tau deposition (using [18F]MK-6240).
Timeframe: 12 years from enrollment
3
Study the temporal dynamics of tau deposition (using [18F]MK-6240).
Timeframe: 12 years from enrollment
4
Study the spatial (both local and distributed) changes of tau deposition (using [18F]MK-6240).
Timeframe: 12 years from enrollment
5
Study the relationship between in vivo tau deposition and neuropathology.
Timeframe: 12 years from enrollment
6
Study the relationship between in vivo tau deposition and neuropathology.
. Has any condition that, in the Investigator's opinion, couldincrease risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severechronic back pain might not be able to lie still duringthe scanning procedures).
. Is deemed likely unable to perform the imaging procedures for any reason.
. Has hypersensitivity to \[18F\]MK-6240or any of its excipients.
. Contraindications to PET, PET-CT or MR(e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
. Severe claustrophobia.
. Women who are currently pregnant or breast-feeding, and women who do not agree to use reliable contraception, or to refrain from sexual activity for 24 hours following administration of the \[18F\]MK-6240injection will be excluded from the study.
. Currently participating in any research studyreceiving an active study medication for AD, an investigational drug, device, imaging, or placebo within the past 30 days before screening, and throughout this clinical trial up to 2-weeks past any study-related procedures.
. Other than the DIAN study, current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the US Code of Federal Regulations (CFR) Title 21 Section 631.1. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1. It is the responsibility of each site to confirm the date of the most recent PET scan and to work within the guidelines of the local Radioactive Drug Research Committee (RDRC) regarding the imaging interval. -