Cognitive Dysfunction study: GE-287 vs Vizamyl
Official title Flutemetamol F 18 Injection Formulation Comparison
ClinicalTrials.gov ID: NCT07873463
What this study is testing
What is GE-287?
GE-287 is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for cognitive dysfunction.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- VIZAMYL (flutemetamol F 18 injection) is a drug used during Positron Emission Tomography (PET) brain scans.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 110
You may be able to join if
- 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...
- The participant has been referred for PET imaging with VIZAMYL (flutemetamol F 18 injection) to estimate amyloid β neuritic plaque density for a)...
- 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...
- use a highly effective method of contraception from Screening until 30 days after the last dose of flutemetamol F 18 injection,
You likely can't join if
- 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...
- Including participation in this study, the participant will have received \>50 mSv total radiation exposure from medical procedures/tests in the past...
- The participant has had a procedure (therapeutic or diagnostic) involving a radioisotope and it is not possible to wait at least 4 disintegration...
- 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
See the full eligibility 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)...
- 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...
- 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...
- 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...
- 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
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Aventura, Florida, United States
- Miami, Florida, United States
- Winter Park, Florida, United States
- Gainesville, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 110 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aventura, Florida, United States; Miami, Florida, United States; Winter Park, Florida, United States; Gainesville, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.