Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 14, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07873463). This is a study registration, not published results. Lead sponsor: GE Healthcare. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 20 participants (ESTIMATED). Conditions: Cognitive Dysfunction. Interventions: DRUG: GE-287; DRUG: Vizamyl; DRUG: Vizamyl; DRUG: GE-287. Primary outcome measures: Comparison of Standard Uptake Value ratio in frontal and anterior cingulate brain region , 90-100 minutes after product administration; Comparison of SUVr in posterior cingulate and precuneus brain region , 90-100 minutes after product administration; Comparison of SUVr in lateral temporal brain region , 90-100 minutes after product administration; Comparison of SUVr in inferolateral parietal brain region , 90-100 minutes after product administration; Comparison of Standard Uptake Value (SUV) in heart , 0-60 minutes after product administration; Comparison of SUV in liver , 0-60 minutes after product administration; Comparison of SUV in kidneys , 0-60 minutes after product administration. Brief summary: 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.