Cognitive DysfunctionPhase 2NCT07873463
Flutemetamol F 18 Injection Formulation Comparison
A Phase 2 study testing GE-287 and Vizamyl in people with Cognitive Dysfunction, run by GE Healthcare at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 110 years
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- GE-287 and Vizamyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesUnited States
- Study dates
- 22 Sep 2026to 25 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- If the participant can become pregnant, the participant must:
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- 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.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
Visionary Investigator Network
Aventura, Florida, 33180
Center for Advanced Research & Education LLC dba Flourish Research Gainesville
Gainesville, Georgia, 30501
Meritt Island Research, LLC dba. Flourish Research
Merritt Island, Florida, 32952
Visionary Investigator Network
Miami, Florida, 33133
Visionary Investigator Network
Miami, Florida, 33176
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789
About this study
Official title: A Multicenter, Phase 2, Open-Label, Randomized, Crossover Comparison of Two Formulations of Flutemetamol F 18 Injection
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.
- Conditions
- Cognitive Dysfunction
- Being tested
- GE-287, Vizamyl
- Keywords
- Alzheimer's disease, Cognitive impairment, PET imaging
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GE-287Drug
Drug: GE-287 185 MBq (±10%) of GE-287 administered intravenously
VizamylDrug
Drug: Vizamyl 185 MBq (±10%) of Vizamyl administered intravenously
VizamylDrug
Drug: Vizamyl 185 MBq (±10%) of Vizamyl administered intravenously
GE-287Drug
Drug: GE-287 185 MBq (±10%) of GE-287 administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| GE-287 then Vizamyl | Other | Not described Receives: Drug: GE-287; Drug: Vizamyl |
| VIZAMYL then GE-287 | Other | Not described Receives: Drug: Vizamyl; Drug: GE-287 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Standard Uptake Value ratio in frontal and anterior cingulate brain region
Measured: 90-100 minutes after product administration
Comparison of SUVr in posterior cingulate and precuneus brain region
Measured: 90-100 minutes after product administration
Comparison of SUVr in lateral temporal brain region
Measured: 90-100 minutes after product administration
Comparison of SUVr in inferolateral parietal brain region
Measured: 90-100 minutes after product administration
Comparison of Standard Uptake Value (SUV) in heart
Measured: 0-60 minutes after product administration
Comparison of SUV in liver
Measured: 0-60 minutes after product administration
Comparison of SUV in kidneys
Measured: 0-60 minutes after product administration
Secondary outcomes (27)
Comparison of global brain Centiloid values
Measured: 90-100 minutes after product administration
Comparison of SUV in heart
Measured: 105-150 minutes after product administration
Comparison of SUV in liver
Measured: 105-150 minutes after product administration
Comparison of SUV in kidneys
Measured: 105-150 minutes after product administration
Comparison of blinded visual image interpretations without quantification
Measured: 90-100 minutes after product administration
Comparison of blinded visual image interpretations with quantification
Measured: Time Frame: 90-100 minutes after product administration
Comparison of inter-reader agreement of the blinded visual image interpretations without quantification
Measured: 90-100 minutes after product administration
Comparison of inter-reader agreement of the blinded visual image interpretations with quantification
Measured: 90-100 minutes after product administration
Safety: Treatment-emergent adverse event [TEAE] incidence
Measured: From pre-administration through 24 hours after product administration
Safety: Changes from baseline in blood hematology
Measured: From pre-administration through 180 minutes after product administration
Safety: Change from baseline in serum biochemistry
Measured: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in urinalysis
Measured: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in blood pressure
Measured: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in heart rate
Measured: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in respiratory rate
Measured: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in temperature
Measured: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in general appearance, rated as normal or abnormal by a qualified healthcare provider.
Measured: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in examination of the heart, rated as normal or abnormal by a qualified healthcare provider.
Measured: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in examination of the lungs, rated as normal or abnormal by a qualified healthcare provider.
Measured: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in 12-lead electrocardiograms [ECGs] heart rate
Measured: from pre-administration through 180 minutes after product administration.
Safety: changes from baseline in 12-lead electrocardiogram [ECG] heart rhythm
Measured: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in 12-lead electrocardiogram [ECG] RR interval
Measured: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in 12-lead electrocardiogram [ECG] PR interval
Measured: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in 12-lead electrocardiogram [ECG] QRS interval
Measured: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in 12-lead electrocardiogram [ECG] QT interval
Measured: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in 12-lead electrocardiogram [ECG] QTc interval
Measured: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in 12-lead electrocardiogram [ECG] notation of abnormalities
Measured: from pre-administration through 180 minutes after product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start22 Sep 2026 (estimated)
- Primary completion25 Feb 2027 (estimated)
- Study completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two-arm crossover design in which each participant will receive both formulations in randomized order, separated by 9 to 14 days.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PSI CRO
- Responsible party
- Sponsor
- Investigators
- Paul Sherwin, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873463
- Sponsor's protocol ID
- GE-287-201
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 2, Open-Label, Randomized, Crossover Comparison of Two Formulations of Flutemetamol F 18 Injection
- ClinicalTrials.gov ID
- NCT07873463
- Acronym / sponsor ID
- GE-287-201
- Conditions
- Cognitive Dysfunction
- Keywords
- Alzheimer's disease, Cognitive impairment, PET imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- PSI CRO
- Study start
- 22 Sep 2026 (estimated)
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 25 Feb 2027 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm crossover design in which each participant will receive both formulations in randomized order, separated by 9 to 14 days.
| Arm | Type | Receives |
|---|---|---|
| GE-287 then Vizamyl | Other | Drug: GE-287, Drug: Vizamyl |
| VIZAMYL then GE-287 | Other | Drug: Vizamyl, Drug: GE-287 |
Who may qualify
- Ages
- 50 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GE-287Drug: GE-287 185 MBq (±10%) of GE-287 administered intravenously | Drug | GE-287 then Vizamyl |
| VizamylDrug: Vizamyl 185 MBq (±10%) of Vizamyl administered intravenously | Drug | GE-287 then Vizamyl |
| VizamylDrug: Vizamyl 185 MBq (±10%) of Vizamyl administered intravenously | Drug | VIZAMYL then GE-287 |
| GE-287Drug: GE-287 185 MBq (±10%) of GE-287 administered intravenously | Drug | VIZAMYL then GE-287 |
Primary outcome
Comparison of Standard Uptake Value ratio in frontal and anterior cingulate brain region
Time frame: 90-100 minutes after product administration
Comparison of SUVr in posterior cingulate and precuneus brain region
Time frame: 90-100 minutes after product administration
Comparison of SUVr in lateral temporal brain region
Time frame: 90-100 minutes after product administration
Comparison of SUVr in inferolateral parietal brain region
Time frame: 90-100 minutes after product administration
Comparison of Standard Uptake Value (SUV) in heart
Time frame: 0-60 minutes after product administration
Comparison of SUV in liver
Time frame: 0-60 minutes after product administration
Comparison of SUV in kidneys
Time frame: 0-60 minutes after product administration
27 secondary outcomes
Comparison of global brain Centiloid values
Time frame: 90-100 minutes after product administration
Comparison of SUV in heart
Time frame: 105-150 minutes after product administration
Comparison of SUV in liver
Time frame: 105-150 minutes after product administration
Comparison of SUV in kidneys
Time frame: 105-150 minutes after product administration
Comparison of blinded visual image interpretations without quantification
Time frame: 90-100 minutes after product administration
Comparison of blinded visual image interpretations with quantification
Time frame: Time Frame: 90-100 minutes after product administration
Comparison of inter-reader agreement of the blinded visual image interpretations without quantification
Time frame: 90-100 minutes after product administration
Comparison of inter-reader agreement of the blinded visual image interpretations with quantification
Time frame: 90-100 minutes after product administration
Safety: Treatment-emergent adverse event [TEAE] incidence
Time frame: From pre-administration through 24 hours after product administration
Safety: Changes from baseline in blood hematology
Time frame: From pre-administration through 180 minutes after product administration
Safety: Change from baseline in serum biochemistry
Time frame: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in urinalysis
Time frame: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in blood pressure
Time frame: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in heart rate
Time frame: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in respiratory rate
Time frame: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in temperature
Time frame: from pre-administration through 180 minutes after product administration
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
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
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
Safety: changes from baseline in 12-lead electrocardiograms [ECGs] heart rate
Time frame: from pre-administration through 180 minutes after product administration.
Safety: changes from baseline in 12-lead electrocardiogram [ECG] heart rhythm
Time frame: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in 12-lead electrocardiogram [ECG] RR interval
Time frame: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in 12-lead electrocardiogram [ECG] PR interval
Time frame: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in 12-lead electrocardiogram [ECG] QRS interval
Time frame: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in 12-lead electrocardiogram [ECG] QT interval
Time frame: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in 12-lead electrocardiogram [ECG] QTc interval
Time frame: from pre-administration through 180 minutes after product administration
Safety: changes from baseline in 12-lead electrocardiogram [ECG] notation of abnormalities
Time frame: from pre-administration through 180 minutes after product administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Sherwin study director
GE Healthcare
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GE-287 and Vizamyl in people with Cognitive Dysfunction, run by GE Healthcare at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Sherwin (+1 (609) 5103686, PaulSherwin@gehealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Standard Uptake Value ratio in frontal and anterior cingulate brain region (time frame: 90-100 minutes after product administration). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.