Flutemetamol F 18 Injection Formulation Comparison

Part of paid clinical trials in Aventura, Florida.

Sponsor
GE Healthcare
Study ID
NCT07873463
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cognitive Dysfunction

Eligibility Criteria

Sex
ALL
Age
50 Years - 110 Years
Healthy Volunteers
Not accepted

Interventions

  • GE-287 — DRUG
    Drug: GE-287 185 MBq (±10%) of GE-287 administered intravenously
  • Vizamyl — DRUG
    Drug: Vizamyl 185 MBq (±10%) of Vizamyl administered intravenously
  • Vizamyl — DRUG
    Drug: Vizamyl 185 MBq (±10%) of Vizamyl administered intravenously
  • GE-287 — DRUG
    Drug: GE-287 185 MBq (±10%) of GE-287 administered intravenously

Study Details

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.

Key Dates

First listed
Oct 14, 2026
Start date
Sep 22, 2026
Status verified
Oct 2026
Primary completion
Feb 25, 2027
Completion
Feb 25, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

Arms

  • Other: GE-287 then Vizamyl
  • Other: VIZAMYL then GE-287

Primary Outcome Measure

Comparison of Standard Uptake Value ratio in frontal and anterior cingulate brain region [ Time Frame: 90-100 minutes after product administration ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Visionary Investigator NetworkAventuraFlorida33180-
Meritt Island Research, LLC dba. Flourish ResearchMerritt IslandFlorida32952-
Visionary Investigator NetworkMiamiFlorida33133-
Visionary Investigator NetworkMiamiFlorida33176-
Clinical Site Partners, LLC dba Flourish ResearchWinter ParkFlorida32789-
Center for Advanced Research & Education LLC dba Flourish Research GainesvilleGainesvilleGeorgia30501-

Find similar trials in Aventura, FL

By research site
Visionary Investigator Network· Aventura, FLMeritt Island Research, LLC dba. Flourish Research· Merritt Island, FLVisionary Investigator Network· Miami, FLClinical Site Partners, LLC dba Flourish Research· Winter Park, FLCenter for Advanced Research & Education LLC dba Flourish Research Gainesville· Gainesville, GA

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