Study of Tau Imaging With the Use of [18F]MK-6240 Tracer

• Conditions: Alzheimer Disease
• Interventions: Drug: MK 6240

• Registration Number: NCT04104659
• Lead Sponsor: Tammie L. S. Benzinger, MD, PhD

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-26
• Study Start: 2021-03-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17
• Primary Completion: 2025-04-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. 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.
2. Male or female participants, at least 18 years of age.
3. Cognitively normal, or with mild dementia, as assessed clinically.
4. 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).
5. Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration. -

Exclusion Criteria

1. 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).
2. Is deemed likely unable to perform the imaging procedures for any reason.
3. Has hypersensitivity to [18F]MK-6240or any of its excipients.
4. 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.
5. Severe claustrophobia.
6. 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.
7. 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.
8. 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. -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MK 6240	MK 6240	-

Primary Outcome Measures

Name	Time	Method
Study the relationship between in vivo tau deposition and neuropathology.	12 years from enrollment	Neuropathological results will be aligned with in vivo imaging using an ex vivo MRI prior to sectioning.
Study the temporal dynamics of tau deposition (using [18F]MK-6240).	12 years from enrollment	A statistical approach will be applied but will consider both Aβ and tau PET. Neuropsychometric measures will be grouped into composites representing working memory, episodic memory, language function, and a global composite. Linear mixed effects models will be implemented including family and DIAN site as random effects. Models will include baseline levels of Aβ PET and tau PET from summary measures, EYO, group (asymptomatic and symptomatic), and all interactions
Study the spatial (both local and distributed) changes of tau deposition (using [18F]MK-6240).	12 years from enrollment	Using novel mathematical models, we will correlate the topography of tau PET with both cross-sectional and longitudinal spatial patterns seen with other imaging biomarkers (Aβ PET and MRI \[structuraland functional\]).

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States