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Not yet recruitingNCT07873463Updated Oct 14, 2026

Flutemetamol F 18 Injection Formulation Comparison

A Phase 2 interventional study of GE-287 and Vizamyl in Cognitive Dysfunction, sponsored by GE Healthcare. Not yet recruiting at 6 sites in United States. Open to participants aged 50 Years to 110 Years. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by GE Healthcare · Phase 2, Interventional, and Diagnostic

Updated Oct 14, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
50 Years to 110 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cognitive Dysfunction

Keywords

  • Alzheimer's disease
  • Cognitive impairment
  • PET imaging
03

In context

Cognitive Dysfunction

3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.

This study's planned enrollment of 20 is below the median of 64 across 2,855 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

GE Healthcare is the lead sponsor of 175 studies on the registry; 20 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.

Browse GE Healthcare studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The participant is at least 50 years of age
  • The participant (or a legally authorized representative of the participant) has read, signed, and dated an informed consent form (ICF) before any study procedures are performed.
  • The participant has been referred for PET imaging with VIZAMYL (flutemetamol F 18 injection) to estimate amyloid β neuritic plaque density for a) evaluation of suspected AD or other causes of cognitive decline and/or b) assessment of participant eligibility for amyloid β-directed therapy for MCI or mild AD as described in the prescribing information of the therapeutic products.
  • The participant is able and willing to comply with all study procedures, including lying supine and still in the PET scanner for at least 60 minutes (approximately 2.5 hours total per imaging session, including a break that will be approximately 30 minutes).

  • The participant is surgically sterile (has had documented bilateral oophorectomy, bilateral salpingectomy, hysterectomy, bilateral orchidectomy, and/or vasectomy with confirmation of success), postmenopausal (cessation of menses for more than 1 year), or:

    1. If the participant can become pregnant, the participant must:

      • use a highly effective method of contraception from Screening until 30 days after the last dose of flutemetamol F 18 injection,
      • have negative results for serum or urine human chorionic gonadotropin pregnancy tests performed at Screening and on the imaging days (with the result known before each administration), and
      • agree not to harvest or donate eggs until at least 30 days after the last dose of IMP.
    2. If the participant can impregnate another person and has a sexual partner who can become pregnant, the participant and partner must use adequate contraception from Screening until 90 days after the last dose of flutemetamol F 18 injection, and the participant must agree not to harvest or donate sperm from screening through 90 days after the last dose of flutemetamol F 18 injection. If the participant has a sexual partner who is already pregnant, both the participant and the partner must provide written informed consent, and both must agree to abstain from any form of sexual contact for at least 24 hours after flutemetamol F 18 injection administration, and both must agree that once sexual contact resumes, they will use condoms until at least 90 days after administration of the last dose of flutemetamol F 18 injection.

Exclusion criteria

Exclusion Criteria:

  • The participant received or plans to receive another IMP within 30 days before signing informed consent until the end of participation in this study.
  • The participant has been treated with, or is being treated with, any medicinal product (drug, biologic, or device) believed to be disease-modifying with regard to MCI or AD (such as an anti-amyloid drug), or initiation of such a medical product cannot be postponed until the participant is no longer in this study.
  • Including participation in this study, the participant will have received >50 mSv total radiation exposure from medical procedures/tests in the past 12 months.
  • The participant has had a procedure (therapeutic or diagnostic) involving a radioisotope and it is not possible to wait at least 4 disintegration half-lives before PET imaging.
  • The participant has a measured or estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 based on eligibility serum laboratory assessments.
  • The participant has a total bilirubin level >1.5X the upper limit of normal (ULN) and/or an aspartate transaminase (AST; serum glutamic-oxaloacetic transaminase [SGOT]) level >3X ULN, and/or an alanine transaminase (ALT, serum glutamic-pyruvic transaminase [SGPT]) level >3X ULN based on eligibility serum laboratory assessments.
  • Except for the participant's cognitive impairment, the participant has a history or current evidence of any condition, therapy, or other circumstance that might confound the results of the study, interfere with participation for the full duration of the study, or put the participant at undue risk as judged by the investigator, such that it is not in the best interest of the participant to participate in this study.
  • The participant has known/suspected structural abnormalities such as a space-occupying lesion or medical devices such as stents, coils, or electrodes in any key region that may interfere with PET imaging or interpretation/analysis of image data.
  • The participant is pregnant, planning to become pregnant, or lactating.
  • The participant has known or suspected diabetes.
  • The participant is not willing or able to fast completely (except for water and any required medications) for at least 6 hours before administration of IMP until after the post-dose blood samples have been collected on each imaging day.
  • The participant has known or suspected allergy or hypersensitivity to either IMP or any of their ingredients (including PS80).
  • The participant was previously enrolled in this study.
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Other
    GE-287 then Vizamyl

    Drug: GE-287 · Drug: Vizamyl

  • Other
    VIZAMYL then GE-287

    Drug: Vizamyl · Drug: GE-287

Interventions

  • DrugGE-287

    Drug: GE-287 185 MBq (±10%) of GE-287 administered intravenously

  • DrugVizamyl

    Drug: Vizamyl 185 MBq (±10%) of Vizamyl administered intravenously

  • DrugVizamyl

    Drug: Vizamyl 185 MBq (±10%) of Vizamyl administered intravenously

  • DrugGE-287

    Drug: GE-287 185 MBq (±10%) of GE-287 administered intravenously

06

What researchers measure

Primary outcomes

  1. Comparison of Standard Uptake Value ratio in frontal and anterior cingulate brain region

    Time frame: 90-100 minutes after product administration

  2. Comparison of SUVr in posterior cingulate and precuneus brain region

    Time frame: 90-100 minutes after product administration

  3. Comparison of SUVr in lateral temporal brain region

    Time frame: 90-100 minutes after product administration

  4. Comparison of SUVr in inferolateral parietal brain region

    Time frame: 90-100 minutes after product administration

  5. Comparison of Standard Uptake Value (SUV) in heart

    Time frame: 0-60 minutes after product administration

  6. Comparison of SUV in liver

    Time frame: 0-60 minutes after product administration

  7. Comparison of SUV in kidneys

    Time frame: 0-60 minutes after product administration

Secondary outcomes

  1. Comparison of global brain Centiloid values

    Time frame: 90-100 minutes after product administration

  2. Comparison of SUV in heart

    Time frame: 105-150 minutes after product administration

  3. Comparison of SUV in liver

    Time frame: 105-150 minutes after product administration

  4. Comparison of SUV in kidneys

    Time frame: 105-150 minutes after product administration

  5. Comparison of blinded visual image interpretations without quantification

    Time frame: 90-100 minutes after product administration

  6. Comparison of blinded visual image interpretations with quantification

    Time frame: Time Frame: 90-100 minutes after product administration

  7. Comparison of inter-reader agreement of the blinded visual image interpretations without quantification

    Time frame: 90-100 minutes after product administration

  8. Comparison of inter-reader agreement of the blinded visual image interpretations with quantification

    Time frame: 90-100 minutes after product administration

  9. Safety: Treatment-emergent adverse event [TEAE] incidence

    Time frame: From pre-administration through 24 hours after product administration

  10. Safety: Changes from baseline in blood hematology

    Time frame: From pre-administration through 180 minutes after product administration

  11. Safety: Change from baseline in serum biochemistry

    Time frame: from pre-administration through 180 minutes after product administration

  12. Safety: changes from baseline in urinalysis

    Time frame: from pre-administration through 180 minutes after product administration

  13. Safety: changes from baseline in blood pressure

    Time frame: from pre-administration through 180 minutes after product administration

  14. Safety: changes from baseline in heart rate

    Time frame: from pre-administration through 180 minutes after product administration

  15. Safety: changes from baseline in respiratory rate

    Time frame: from pre-administration through 180 minutes after product administration

  16. Safety: changes from baseline in temperature

    Time frame: from pre-administration through 180 minutes after product administration

  17. Safety: changes from baseline in general appearance, rated as normal or abnormal by a qualified healthcare provider.

    Time frame: from pre-administration through 180 minutes after product administration

  18. Safety: changes from baseline in examination of the heart, rated as normal or abnormal by a qualified healthcare provider.

    Time frame: from pre-administration through 180 minutes after product administration

  19. Safety: changes from baseline in examination of the lungs, rated as normal or abnormal by a qualified healthcare provider.

    Time frame: from pre-administration through 180 minutes after product administration

  20. Safety: changes from baseline in 12-lead electrocardiograms [ECGs] heart rate

    Time frame: from pre-administration through 180 minutes after product administration.

  21. Safety: changes from baseline in 12-lead electrocardiogram [ECG] heart rhythm

    Time frame: from pre-administration through 180 minutes after product administration

  22. Safety: changes from baseline in 12-lead electrocardiogram [ECG] RR interval

    Time frame: from pre-administration through 180 minutes after product administration

  23. Safety: changes from baseline in 12-lead electrocardiogram [ECG] PR interval

    Time frame: from pre-administration through 180 minutes after product administration

  24. Safety: changes from baseline in 12-lead electrocardiogram [ECG] QRS interval

    Time frame: from pre-administration through 180 minutes after product administration

  25. Safety: changes from baseline in 12-lead electrocardiogram [ECG] QT interval

    Time frame: from pre-administration through 180 minutes after product administration

  26. Safety: changes from baseline in 12-lead electrocardiogram [ECG] QTc interval

    Time frame: from pre-administration through 180 minutes after product administration

  27. Safety: changes from baseline in 12-lead electrocardiogram [ECG] notation of abnormalities

    Time frame: from pre-administration through 180 minutes after product administration

07

Study locations

6 sites
  • Visionary Investigator Network
    Aventura, Florida 33180, United States
  • Meritt Island Research, LLC dba. Flourish Research
    Merritt Island, Florida 32952, United States
  • Visionary Investigator Network
    Miami, Florida 33133, United States
  • Visionary Investigator Network
    Miami, Florida 33176, United States
  • Clinical Site Partners, LLC dba Flourish Research
    Winter Park, Florida 32789, United States
  • Center for Advanced Research & Education LLC dba Flourish Research Gainesville
    Gainesville, Georgia 30501, United States
08

References and documents

Individual participant data

Plan to share: No — There is not a plan to make IPD available.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.

Of 39 industry-sponsored phase 2 interventional studies under Cognitive Dysfunction, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 37. This study's planned 5 months is below that.

Counting every sponsor, half of 183 studies reached it within 44 months; a quarter within 22 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2026
First posted
Oct 14, 2026
StartEst.
Sep 22, 2026
Primary completionEst.
Feb 25, 2027
CompletionEst.
Feb 25, 2027
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07873463
Lead sponsor
GE Healthcare
Collaborators
PSI CRO
Responsible party
Sponsor
First posted
Oct 14, 2026
Start date
Sep 22, 2026 (estimated)
Primary completion
Feb 25, 2027 (estimated)
Completion
Feb 25, 2027 (estimated)
Last update
Oct 14, 2026

Study contacts

Paul Sherwin
Contact
PaulSherwin@gehealthcare.com
+1 (609) 5103686
Victoria Haas
Contact
ge287201@gehealthcare.com
011 33 6 29 86 53 56
Paul Sherwin
study director · GE Healthcare

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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