RecruitingPhase 3NCT06254469

Visualizing Brain Proteinopathies Using [F-18]Flornaptitril-PET in the Prediction of Clinical Progression of Mild Cognitive Impairment With Either Suspected Chronic Traumatic Encephalopathy or Alzheimer's Disease


Sponsor

CereMark Pharma, LLC

Enrollment

230 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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 clinical progression of Mild Cognitive Impairment (MCI) with either Suspected Chronic Traumatic Encephalopathy (CTE) or Alzheimer's Disease (AD). The primary objectives of the study are to: (1) To determine the accuracy of F-18 FNT-PET in prediction of clinical decline and (2) To assess the safety and tolerability of F-18 FNT. The secondary objectives include: (1) To demonstrate the feasibility of F-18 FNT-PET in differentiation of participants with suspected chronic traumatic encephalopathy (CTE) from those with suspected Alzheimer's disease (AD) by trained image readers, (2) To evaluate disease progression in participants with suspected CTE or AD and (3) To evaluate the correlation between F-18 FNT-PET regional and summary visual reads scan and other assessments.


Eligibility

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study uses a specialized PET scan with a new imaging agent called [F-18]flornaptitril to visualize abnormal protein buildup in the brains of people with mild cognitive impairment (MCI). The goal is to determine whether this scan can detect signs of either chronic traumatic encephalopathy (CTE — brain injury from repeated head trauma) or Alzheimer's disease before significant memory loss sets in. **You may be eligible if...** - You are 45 or older with MCI suspected to be related to CTE, or 50 or older with MCI suspected to be related to Alzheimer's disease - You have a trusted companion (friend or family member) who sees you at least 3–4 times per week and can attend all clinic visits with you - Female participants must be post-menopausal or surgically sterilized **You may NOT be eligible if...** - You do not have a regular companion able to assist with study visits - You have other neurological conditions that may explain your cognitive symptoms - You do not meet the specific MCI diagnostic criteria for this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[F-18]Flornaptitril

All participants will receive a single dose of F-18 FNT during an imaging visit.


Locations(1)

Endeavor Health Systems

Evanston, Illinois, United States

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NCT06254469


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