Flornaptitril-PET for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how well a new imaging method, using a substance called F-18 Flornaptitril (a radiotracer), can predict the progression of memory problems in people with Mild Cognitive Impairment (MCI) potentially due to Alzheimer's Disease or Chronic Traumatic Encephalopathy (CTE). The goal is to determine if this imaging can accurately forecast further cognitive decline and safely distinguish between these two conditions. People with a history of memory issues due to suspected Alzheimer's or repeated head injuries may be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking diagnostic tool.
Do I have to stop taking my current medications for the trial?
If you are taking acetylcholinesterase inhibitors or memantine, you should continue on a stable dosage for the trial. However, you must avoid benzodiazepines within 24 hours before trial visits and ibuprofen or naproxen within 5 days before the PET scan.
Is there any evidence suggesting that [F-18]Flornaptitril is likely to be safe for humans?
Research has shown that F-18 Flornaptitril, a new drug for medical imaging, has been safely tested in earlier studies. These studies found that people generally tolerate the treatment well, with no major safety issues reported. Used with PET scans, which are special imaging tests, F-18 Flornaptitril helps doctors see inside the brain. This enables doctors to safely use it to understand how brain conditions like Alzheimer's Disease or Chronic Traumatic Encephalopathy might develop over time.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about [F-18]Flornaptitril because it offers a novel approach to diagnosing Alzheimer's Disease (AD) and Chronic Traumatic Encephalopathy (CTE). Unlike existing treatments that primarily focus on managing symptoms, [F-18]Flornaptitril is a radioactive tracer used in PET imaging to detect specific brain changes associated with these conditions. This imaging technique allows for more accurate and earlier detection of the diseases by highlighting abnormal protein deposits in the brain, which are hallmarks of AD and CTE. This could lead to better-targeted therapies and improved patient outcomes by catching the diseases in their earlier stages.
What evidence suggests that F-18 Flornaptitril-PET is effective for predicting clinical progression in Alzheimer's Disease and Chronic Traumatic Encephalopathy?
Research shows that [F-18]Flornaptitril PET scans can identify tau and beta-amyloid proteins in the brain. These proteins are key indicators of Alzheimer's disease and suspected chronic traumatic encephalopathy (CTE). The trial includes separate arms for participants with mild cognitive impairment (MCI) due to suspected Alzheimer's disease and those with MCI due to suspected CTE. Studies suggest that this imaging method might predict how mild cognitive impairment will progress in people with these conditions. Identifying these protein build-ups aids in understanding disease development. Early findings also indicate that [F-18]Flornaptitril can safely differentiate between Alzheimer's and CTE, which is crucial for creating specific treatment plans.26789
Who Is on the Research Team?
Chad Yucus, MD
Principal Investigator
Endeavor Health System
Are You a Good Fit for This Trial?
This trial is for adults with Mild Cognitive Impairment (MCI) suspected to be due to Chronic Traumatic Encephalopathy (CTE) or Alzheimer's Disease (AD). They must have stable mental health, not explained by other disorders or conditions, and should either be on a steady dose of cognitive medications or not require them. Participants need a partner for clinic visits and compliance, an MMSE-2 score of 22-30, and documented memory decline.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive F-18 FNT-PET imaging to evaluate safety and efficacy for predicting clinical progression of MCI with suspected CTE or AD
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of disease progression and safety evaluations
What Are the Treatments Tested in This Trial?
Interventions
- [F-18]Flornaptitril
Trial Overview
[F-18]Flornaptitril-PET imaging is being tested to predict clinical progression in MCI patients with possible CTE or AD. The study aims to assess the accuracy of this PET scan in predicting decline, differentiate between CTE and AD, evaluate disease progression over time, and correlate scan results with other assessments.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Part B plans to enroll 90 participants with MCI due to suspected CTE from concussive and percussive injuries in approximately 1:1 ratio for primary accuracy assessments of F-18 FNT-PET imaging.
Part B plans to enroll 90 participants with MCI due to suspected AD for primary accuracy assessments of F-18 FNT-PET imaging.
Part A plans to enroll 50 participants (approximately 20 participants with mild cognitive impairment \[MCI\] due to suspected CTE, 20 participants with MCI due to suspected AD, and 10 age-matched healthy volunteers, whose age is within 3 years of any participants with MCI due to suspected CTE or AD in Part A).
Find a Clinic Near You
Who Is Running the Clinical Trial?
CereMark Pharma, LLC
Lead Sponsor
Citations
Amyloid-β assessed by florbetapir F 18 PET and 18-month ...
Florbetapir F 18 PET can image amyloid-β (Aβ) aggregates in the brains of living subjects. We prospectively evaluated the prognostic utility of detecting Aβ ...
Predictive Value of 18F-Florbetapir and 18F-FDG PET for ...
The present study examined the predictive values of amyloid PET, 18F-FDG PET, and nonimaging predictors (alone and in combination) for development of Alzheimer ...
CereMark Pharma Begins Phase III Trial of F-18 ...
F-18 Flornaptitril was designed to simultaneously detect tau aggregates and beta-amyloid plaques within a single PET scan
Clinical Relevance of [18F]Florbetaben and [18F]FDG PET ...
[ 18 F]FBB combined with [ 18 F]FDG PET is a helpful tool for differential diagnosis, and supports the patients' management as well as treatment.
Phase III Study of the Correlation Between Florbetapir F18 ...
The study is designed to test the relationship between measurements of brain amyloid using florbetapir F 18 PET imaging and true levels of amyloid by ...
Visualizing Brain Proteinopathies Using [F-18]Flornaptitril ...
CMK-0301 is a multi-site, randomized clinical trial to evaluate the safety and efficacy of [F-18]Flornaptitril-PET (F-18 FNT-PET) for the prediction of ...
[F-18]Flornaptitril - Drug Targets, Indications, Patents
Alzheimer's disease (AD) is a neurodegenerative disorder that results in memory deficits. The effect of AD is the leading cause of dementia ...
Amyvid (Florbetapir F 18 Injection) for intravenous use
HIGHLIGHTS OF PRESCRIBING INFORMATION. These highlights do not include all the information needed to use Amyvid safely and effectively.
F-18 Flornaptitril
F-18 Flornaptitril is a new investigational radiopharmaceutical used in conjunction with Positron Emission Tomography (PET) and has been safely tested in ...
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