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.
Diagnosis of MCI due to suspected AD according to workgroups of the Diagnostic Guidelines of the National Institute on Aging and Alzheimer's Association (NIA-AA)
Documented evidence of memory decline with gradual onset and slow progression for at least 1 year. If medically documented evidence is not available, an informant may provide confirmatory evidence
An MMSE-2 score of 22 to 30, inclusive, at the Screening Visit
Biomarker positive based on predefined plasma p-tau cutoff
Pregnant or breastfeeding
Unable to remain still for duration of imaging procedure or have an inability to tolerate neuropsychological, clinical, or PET scan studies (e.g., head tremor that may cause head motion artifact, uncontrollable psychosis, acute suicidality)
History of stroke, transient ischemic attack, seizures, or other condition of the head or neck within 12 months prior to the Screening Visit that, in the Investigator's opinion, might affect circulation to the head or image interpretation
Preexisting major neurologic or other physical illness that could confound results (e.g., multiple sclerosis, diabetes, cancer)
Parallel
[F-18]Flornaptitril
DrugAll participants will receive a single dose of F-18 FNT during an imaging visit.
Accuracy of F-18 FNT-PET in prediction of clinical decline
The correlation between predictive development of neurodegeneration as made from F-18 FNT-PET and score change from baseline on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at the 2-year Follow-up Visit
Assessment of the safety of F-18 FNT using adverse events and serious adverse events.
Adverse events and serious adverse events will be monitored in patients following F-18 FNT administration.
Assessment of the safety of F-18 FNT using vital signs.
A patients body temperature, respiratory rate, sitting radial pulse rate, and sitting systolic and diastolic blood pressures will be monitored in patients following F-18 FNT administration.
Assessment of the safety of F-18 FNT using clinical laboratory assessments.
A patients complete blood count with differential, free T4 Index, Vitamin B12 serum, chemistry panel (glucose, calcium, sodium, potassium, carbon dioxide, chlorine, albumin and total protein, ALP, ALT, AST, bilirubin, BUN, creatinine), benzodiazepines, uric acid, thyroid-stimulating hormone, and cholesterol will be monitored in patients following F-18 FNT administration.
Feasibility of F-18 FNT-PET to differentiate suspected CTE from suspected AD.
The binding patterns of F-18 FNT-PET will be assed in each patient to differentiate those patients with suspected chronic traumatic encephalopathy (CTE) from those with suspected Alzheimer's disease (AD) by trained image readers using pattern determination (for presence versus no presence of CTE or AD type pattern).
Evaluation of disease progression in participants with suspected CTE or AD using the CDR-SB at the 2-year follow-up visit.
The change from baseline in scores on the Clinical Dementia Rating Scale Sum of Box Scores (CDR-SB) at the 2-year follow-up visit will be used to assess the disease progression in participants with suspected CTE or AD.
Evaluation of disease progression in participants with suspected CTE or AD using the 36-Item Short Form Survey (SF-36).
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of 36-Item Short Form Survey (SF-36).
Evaluation of disease progression in participants with suspected CTE or AD using the STOP-BANG Questionnaire for Sleep Apnea.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the STOP-BANG Questionnaire for Sleep Apnea.
Correlation of F-18 FNT binding patterns neuropathology at autopsy.
To determine the correlation between regional F-18 FNT binding and regional neuropathology (concentration of tau tangles and amyloid-beta (Aβ) plaques) at autopsy.
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