R21 Roche: 3-Way Tau Tracers in AD

PHASE1RecruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

February 1, 2023

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
Alzheimer Disease
Interventions
DRUG

[18F]RO-948

"Johns Hopkins University has conducted the first in human study in collaboration with Roche for 18F-RO948and found that 18F-RO948isa promising radioligand for imaging tau pathology in AD, showing excellent brain uptake and displaying little off-target binding(22, 17, 34).The injected activity for18F-RO948will be as low as practicable, while still allowing accurate quantification of the PET images.The injected dose of 370MBq(10mCi)has been selected based on the radiation dose estimates for18F-RO948gathered in human subjects provided by Michael Stabin, Ph.D., and in accordance with the principle that radiation doses should be as low as reasonably achievable.~This radiotracer will be manufactured on site in the Mallinckrodt Institute of Radiology Cyclotron Facility, a certified Nuclear Pharmacy."

DRUG

18F-MK6240

"18F-MK6240 is an investigational PET radiotracer discovered by Merck Research Laboratories and is being developed by Cerveau Technologies, Inc.,for imaging neurofibrillary tangles (NFTs)in the brains of people withAlzheimerdisease.18F-MK6240 has been reported to exhibit good kinetics with high binding levels to brain regions associated with deposition of neurofibrillary tangles in people with AD(35,36).The tracer has been used to monitor the progression of AD.The injected activity for18F-MK6240 will be as low as practicable, while still allowing accurate quantification of the PET images.The injected dose will be 185MBq(5mCi) has been selected based on the radiation dose estimates gathered in human subjects(37)and in accordance with the principle that radiation doses should be as low as reasonably achievable.~This radiotracer will be manufactured on site in the Mallinckrodt Institute of Radiology Cyclotron Facility, a certified Nuclear Pharmacy."

DRUG

18F-GTP1

"18F-GTP1is anInvestigational tau PET radiotracer being developed by Genentech for imaging intraneuronal neurofibrillary tangles in patients with AlzheimerDisease. 18F-GTP1 has been reported to exhibit high affinity and selectively for tau pathology, favorable dosimetry and brain kinetics. Degree of 18F-GTP1-specific binding increased withAD severity, could differentiate diagnostic cohorts, and monitor longitudinal change in tau burden.~18F-GTP1 will be provided from LMI sourced through Illinois or New Jersey certified location."

Trial Locations (1)

63110

RECRUITING

Washington University School of Medicine, St Louis

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

Washington University School of Medicine

OTHER