Actively Recruiting
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
Led by CereMark Pharma, LLC · Updated on 2025-07-30
230
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Mild Cognitive Impairment (MCI) due to suspected Chronic Traumatic Encephalopathy (CTE) if aged over 45, or suspected Alzheimer's Disease (AD) if aged over 50
- Have a trial partner interacting 3-4 times per week to assist with trial procedures
- Provide informed consent with a trial partner
- Female participants must be surgically sterilized, post-menopausal for at least 1 year, or have a negative pregnancy test
- Willing to comply with trial procedures and communicate with trial personnel
- Willing to attend follow-up visits at 1 and 2 years after imaging (Part B)
- Global Clinical Dementia Rating (CDR) score of 0.5
- For suspected CTE: Meet diagnostic criteria including persistent symptoms over 2 years, history of repetitive head trauma, progressive course, delayed symptom onset, and cognitive decline in multiple domains
- For suspected CTE: Have at least one supportive feature such as emotional dysregulation, behavioral change, or motor disturbance
- For suspected AD: Meet diagnostic guidelines including documented memory decline for at least 1 year, MMSE-2 score 22 to 30, biomarker positive for plasma p-tau, Modified Hachinski Ischemic Score ≤4, no delirium or other mental disorder explaining cognitive deficits, and stable or no treatment with specific Alzheimer's medications
- Healthy volunteers (Part A): Medically healthy, age within 3 years of MCI participants, no cognitive impairment, no family history of early-onset AD or other neurodegenerative diseases, MMSE-2 score ≥27
You will not qualify if you...
- Pregnant or breastfeeding
- Unable to remain still during imaging or tolerate neuropsychological, clinical, or PET scan studies
- History of stroke, transient ischemic attack, seizures, or head/neck conditions within 12 months affecting head circulation or image interpretation
- Major neurological or physical illnesses that could affect results
- Psychiatric disorders that interfere with trial procedures
- Conditions or circumstances interfering with data collection
- History of significant drug or alcohol abuse
- Prior exposure to F-18 FNT or investigational products within 30 days
- Allergic reactions to albumin or severe anemia or cardiac failure contraindicating albumin
- Unstable cardiac disease or uncontrolled hypertension
- Use of benzodiazepines within 24 hours before visits
- Planned use of ibuprofen or naproxen within 5 days before PET scan
- Recent radioactive drug use or scans conflicting with trial
- Implants or MRI contraindications
- Brain lesions or infections unrelated to trial
- Participation in other clinical trials with investigational agents within 90 days
- Monoclonal antibody treatment within 180 days
- Plan to receive approved treatments for early AD during trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Endeavor Health Systems
Evanston, Illinois, United States, 60201
Actively Recruiting
Research Team
H
Henry M Chilton, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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