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Not yet recruitingPhase 2

Flutemetamol F 18 Injection Formulation Comparison

A Multicenter, Phase 2, Open-Label, Randomized, Crossover Comparison of Two Formulations of Flutemetamol F 18 Injection

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 110 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "VIZAMYL (flutemetamol F 18 injection) is a drug used during Positron Emission Tomography (PET) brain scans."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares GE-287, a new form of VIZAMYL, with the current form used in PET brain scans to find amyloid, a protein linked to Alzheimer's disease. It checks how well the new form works, where it goes in the body, and its safety. It is for adults age 50 or older who have been referred for a VIZAMYL brain scan.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be at least 50 years old.
  • You or your legal representative must sign and date a consent form before any study procedures.
  • You must have been referred for a VIZAMYL PET scan to check memory or thinking problems, or to see if you qualify for treatment that targets amyloid.
  • You must be willing and able to follow all study steps, including lying still on your back for at least 60 minutes. Each scan visit takes about 2.5 hours, including a break of about 30 minutes.
  • You must meet the study's rules for preventing pregnancy, unless you have had a confirmed surgery that prevents pregnancy or have gone through menopause with no periods for more than a year.
  • If you can become pregnant, you must use highly effective birth control from screening until 30 days after the last dose. You must have negative pregnancy tests at screening and on scan days, and avoid egg collection or donation until at least 30 days after the last dose.
  • If you can get a partner pregnant, you and that partner must use birth control from screening until 90 days after the last dose. You must also avoid sperm collection or donation during that time.
  • If your partner is pregnant, both of you must give written consent and avoid all sexual contact for at least 24 hours after each dose. After that, you must use condoms until at least 90 days after the last dose.

Who can't join

  • You used another study drug within 30 days before signing consent, or plan to use one during this study. You also cannot have used, currently use, or need to start a treatment meant to slow Alzheimer's disease or mild memory and thinking problems during this study.
  • Your medical radiation exposure, including this study, would be over 50 mSv in 12 months. You also cannot join if a recent radioactive test or treatment has not had enough time to fade before the scan.
  • Your kidney filtering test result is below 60. You also cannot join if liver tests show bilirubin over 1.5 times the normal upper limit, or AST or ALT over 3 times that limit.
  • You have another health problem, treatment, or situation that the study doctor thinks could make the study unsafe, affect the results, or keep you from finishing. A growth or device in an important scan area that could affect the images may also rule you out.
  • You are pregnant, plan to become pregnant, or are breastfeeding.
  • You have known or suspected diabetes, or cannot go without food and drinks other than water for at least 6 hours before each dose until blood samples are collected afterward. Required medicines are allowed.
  • You have a known or suspected allergy to either study drug or any ingredient, including PS80.
  • You have already enrolled in this study before.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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: * 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.

Study sites (6)

FL

GA