Phase 2Not yet recruitingAge-related condition
Flutemetamol F 18 Injection Formulation Comparison
A Multicenter, Phase 2, Open-Label, Randomized, Crossover Comparison of Two Formulations of Flutemetamol F 18 Injection
- Sponsor
- GE Healthcare (Industry)
- Enrolment
- 20 planned
- Conditions
- Cognitive Dysfunction
- Interventions
- GE-287; Vizamyl; Vizamyl; GE-287
- Ages
- adults, older adults
- Registry
- NCT07873463
Full record on ClinicalTrials.gov
From the registry
VIZAMYL (flutemetamol F 18 injection) is a drug used during Positron Emission Tomography (PET) brain scans. It helps doctors detect the presence of amyloid protein, which is associated with Alzheimer's disease and other conditions affecting memory or thinking. A new formulation of this drug, called GE-287, has been developed. This new formulation may offer advantages for patient tolerability and can be produced more reliably and efficiently. The aim of the study is to determine whether the new formulation works as well as the current one in identifying amyloid in the brain, how it distributes in the body, and whether it is safe for use. The study will measure how much of the study drug goes to different organs (including the brain, heart, liver, and kidneys) and monitor for any side effects.
Primary outcomes
- Comparison of Standard Uptake Value ratio in frontal and anterior cingulate brain region
- Comparison of SUVr in posterior cingulate and precuneus brain region
- Comparison of SUVr in lateral temporal brain region
- Comparison of SUVr in inferolateral parietal brain region
History
Primary completion expected
Registered
Started