Flutemetamol Formulations for Cognitive Impairment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new version of a drug used during brain scans to detect amyloid protein, which is linked to Alzheimer's and memory issues. The goal is to determine if the new drug matches the current one in effectiveness and safety. Participants should be experiencing cognitive decline and require a PET scan for amyloid-related assessment. The trial will examine how the drug distributes in the body and identify any side effects. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Vizamyl, already approved for brain scans, is generally safe and well-tolerated. It aids in detecting amyloid protein, which is linked to Alzheimer's disease. Importantly, studies indicate that it does not cause genetic damage, a positive sign for safety.
For the new version, GE-287, less information is available. Since this study is in its early stages, researchers are still carefully checking safety. Early trials typically focus on ensuring a treatment's safety for people, so any serious side effects would likely have been identified by now.
Both treatments aim to detect brain changes related to memory problems. These studies are designed to closely monitor for any side effects, prioritizing participant safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about GE-287 and Vizamyl because they offer new approaches to addressing cognitive impairment. Unlike the standard treatments that often focus on symptom management, Vizamyl utilizes flutemetamol F 18, a radioactive tracer that helps visualize amyloid plaques in the brain, a key feature of Alzheimer's disease. GE-287 is unique because it potentially targets different aspects of cognitive decline, offering a complementary approach to existing options. These innovations provide hope for more precise diagnosis and possibly more effective treatment strategies for cognitive impairment.
What evidence suggests that this trial's treatments could be effective for cognitive impairment?
Research has shown that Vizamyl helps doctors identify amyloid protein in the brain, which is linked to Alzheimer's disease. In two studies involving 384 participants, Vizamyl effectively detected Alzheimer's by targeting amyloid plaques. These plaques are significant because they are associated with memory problems.
In this trial, participants will receive both Vizamyl and the new version, GE-287, in different sequences. Researchers are developing GE-287 to determine if it performs as well as Vizamyl. Although human data on GE-287 is not yet available, it is designed to be more comfortable for patients and easier to produce. The goal is for it to detect amyloid in the brain just as effectively.678910Who Is on the Research Team?
Paul Sherwin
Principal Investigator
GE Healthcare
Are You a Good Fit for This Trial?
This trial is for people with memory or thinking problems, such as cognitive impairment or agitation, who need a PET brain scan to check for amyloid protein. Participants should not have conditions that would make the scan unsafe.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either GE-287 or VIZAMYL for PET brain scans to compare formulations
Crossover
Participants switch to the alternate formulation for further comparison
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GE-287
- Vizamyl (flutemetamol F 18 injection)
Trial Overview
The study compares two versions of flutemetamol F 18 injection—GE-287 (a new formulation) and Vizamyl (the current one)—to see if the new version works just as well in detecting amyloid in the brain during PET scans and if it is safe.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
GE Healthcare
Lead Sponsor
Fotis Vlachos
GE Healthcare
Chief Marketing Officer since 2024
PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania
Peter J. Arduini
GE Healthcare
Chief Executive Officer since 2022
MBA from Northwestern University, BSc in Marketing from Susquehanna University
PSI CRO
Industry Sponsor
Citations
Resilience to cognitive impairment in the oldest-old - PMC - NIH
The EMIF-AD 90+ Study aims to identify factors associated with resilience to cognitive impairment in the oldest-old. In this paper we reviewed previous studies ...
Evaluation of Cognitive and Physical Training on MCI Elders
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NCT00010803 | Ginkgo Biloba Prevention Trial in Older ...
This study will determine the effect of 240mg/day Ginkgo biloba in decreasing the incidence of dementia and specifically Alzheimer's disease (AD), slowing ...
4.
alzforum.org
alzforum.org/news/research-news/paper-alert-guidage-trial-data-ginkgo-biloba-publishedPaper Alert—GuidAge Trial Data on Ginkgo Biloba Published
“ginkgo biloba does not prevent dementia in elderly individuals with or without memory complaint or cognitive impairment, and is not effective ...
Effects of Cognitive Intervention for Older Adults With ...
The purpose of this study is to evaluate the effects of training in memory skills vs. use of external memory aids on everyday memory functioning in older people
Cognitive resilience among APOE ε4 carriers in the oldest old
Objectives: Relatively few APOE ε4+ carriers survive to old age (age 80+) without cognitive impairment (CI); thus, little is known about distinguishing ...
7.
gaintherapeutics.com
gaintherapeutics.com/newsroom/press-releases/press-releases-2024/gain-therapeutics-presents-preclinical-gt-02287-data-at-neuroscience-2024/Gain Therapeutics Presents Preclinical GT-02287 Data at ...
GT-02287 was shown to rescue deficits in neuromuscular function and motor coordination in both models as well as to prevent the development of ...
8.
uspreventiveservicestaskforce.org
uspreventiveservicestaskforce.org/uspstf/document/evidence-summary28/cognitive-impairment-in-older-adults-screening-2014Cognitive Impairment in Older Adults: Screening
Background: Earlier identification of cognitive impairment may reduce patient and caregiver morbidity. Purpose: To systematically review the ...
Alzheimer's Drug Fails Cognitive Endpoint
We believe that the data supports the advancement of a 100-mg dose of CT1812 in additional clinical trials in a mild-to-moderate AD patient ...
10.
healthcare-brew.com
healthcare-brew.com/stories/2024/09/25/ge-healthcare-clearance-alzheimers-detection-toolGE HealthCare wins clearance for Alzheimer's detection tool
The Chicago-based medical device company announced on September 17 that it received FDA clearance to use its brain-scanning software MIMneuro, ...
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